Marius Pharmaceuticals

News

The Testosterone Project Launches on National Testosterone Awareness Day, November 17

New Nonprofit Founded by Leading Testosterone Experts Seeks to Provide Equal Access to Care for Both Men and Women

RALEIGH, N.C., Nov. 15 2024 — The Testosterone Project, a new nonprofit founded by leading experts in the fields of testosterone treatment and general metabolic health, launches in conjunction with National Testosterone Awareness Day on November 17. The national nonprofit organization will focus on addressing the stigma and misconceptions surrounding testosterone, advocating for comprehensive testing, and supporting women’s equal access to testosterone deficiency treatment.

The Testosterone Project’s executive board is comprised of industry leaders, medical professionals, and passionate advocates dedicated to expanding access to testosterone treatments and testing. Shalin Shah, longevity expert and CEO of Marius Pharmaceuticals, is joined by Dr. Mohit Khera, a renowned urology expert and professor, and Dr. Kelly Casperson, a urologist and prominent advocate for women’s health. The board will provide scientific expertise, educational resources, and support in promoting testosterone health.

The project also has an extensive, growing advisory board that consists of longevity experts in urology, cardiology, functional medicine, and more. Since testosterone plays such a broad role in metabolic health, the executive board has brought in experts across the entire spectrum, including patients, to help drive the cause.

The Testosterone Project comes at a critical time, addressing the testosterone deficiency health crisis and widespread lack of clear, unbiased information for both men and women. The nonprofit’s long-term goals include descheduling testosterone to improve access and reduce regulatory barriers for testosterone testing standards on blood panels.

The result helps diagnose deficiency and provides insights into overall health, serving as a key marker for underlying conditions. It also supports long-term well-being and makes FDA-approved testosterone available for women who are suffering from the same broad symptoms and health risks as men. The Testosterone Project believes that increasing public and healthcare awareness around testosterone deficiency is key to reducing the stigma and making the therapy mainstream.

Descheduling testosterone would simplify prescribing, increase access, and reduce the stigma around testosterone therapy:

For healthcare providers: could lead to fewer regulatory hurdles
For patients: more accessible and affordable treatment options
For the industry: Fewer regulatory limitations that might encourage further innovation in testosterone therapies

Through lobbying efforts, partnerships with medical organizations, awareness campaigns, and educational outreach to lawmakers and the public, The Testosterone Project will spread awareness and create momentum for critical policy changes surrounding testosterone classification.

For women, there are zero FDA-approved testosterone therapies and limited awareness. By addressing this disparity, The Testosterone Project ensures women have equitable access to hormone therapies that may improve quality of life, combat symptoms of deficiency, and support overall health. According to the National Library of Medicine, women have experienced improved mood, libido, and physical well-being after being on testosterone therapy, underscoring the importance of equality in hormone treatments for men and women.

Executive Board Member Shalin Shah comments, “The time to take a stand is now. The science is overwhelmingly clear on how important this metabolic hormone is and the impact it can make on the overall health of our population. Through education and awareness, we can not only improve the lives of millions but actually start to address some of the ticking time bombs when it comes to our healthcare system’s spending.”

To support The Testosterone Project’s efforts, the public can sign up for newsletters to learn how to get involved, participate in petitions advocating for regulatory changes, and spread awareness through social media. The project will also offer educational materials or webinars to engage the public.

For more information on The Testosterone Project, visit testosteroneproject.com.

News

New Data from Marius Pharmaceuticals Reveals High Prevalence of Low Libido, Energy and Quality of Life in Men

RALEIGH, N.C., Nov. 14, 2024 (GLOBE NEWSWIRE) — Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, has released compelling new insights from a recent Androgen Deficiency in Aging Males (qADAM) questionnaire conducted on their KYZATREX^® (testosterone undecanoate) CIII capsules website. The data collected from 779 participants highlights significant challenges faced by men regarding energy, libido, strength and overall life satisfaction, underscoring the potential impact of testosterone deficiency on quality of life and well-being.

Below are the results from men who responded to the qADAM questionnaire, a validated tool for assessing testosterone deficiency symptoms:

75% rated their libido as poor or terrible
76% rated their energy level as poor or terrible
66% rated their strength and/or endurance as poor or terrible
62% rated their enjoyment of life as poor or terrible
46% rated their happiness level as poor or terrible
72% rated the strength of their erections as somewhat or extremely weak
53% rated their work performance over the past 4 weeks as poor or terrible
59% fall asleep at least 3-4x/week after eating dinner
72% rated their sports ability over the past 4 weeks as poor or terrible

Together, this data reflects a broader pattern of symptoms often associated with low testosterone, highlighting the need for accessible solutions to support men experiencing these challenges. View the infographic for a detailed results breakdown.

“This data reinforces the necessity for greater awareness and resources to address men’s health concerns, particularly testosterone deficiency, which can profoundly affect physical and emotional well-being,” said Amit Shah, Chief Operating Officer of Marius Pharmaceuticals. “At Marius, we are committed to providing safe, effective options for managing low testosterone symptoms with products like KYZATREX.”

KYZATREX is an FDA-approved oral form of testosterone replacement therapy (TRT) indicated for adult males experiencing low or no testosterone due to certain medical conditions. A six-month clinical trial demonstrated that KYZATREX was up to 96% effective at Day 90 at restoring normal testosterone levels in adult men who have low or no testosterone levels due to certain medical conditions.^1,2*

*Per label, 88% of patients had low testosterone levels at Day 90 (worst-case scenario calculation, excluding Site 104). Based on patients who completed the study (n=127), 96% of patients achieved normal testosterone levels at Day 90.¹

Testosterone deficiency, also known as hypogonadism, affects millions of men worldwide and is associated with various chronic conditions, including obesity, diabetes and depression.^3,4 As the global demand for men’s health solutions grows, Marius Pharmaceuticals continues to prioritize patient-centered therapies, empowering men to take control of their health and well-being.

For more information on KYZATREX, visit www.kyzatrex.com.

About Marius Pharmaceuticals
Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company’s vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.

Important Safety Information for KYZATREX^®

KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
If your blood pressure cannot be controlled, KYZATREX may need to be stopped.
Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX.

Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).

Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX may cause other serious side effects including:

Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.
If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
Increased risk of prostate cancer.
Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
In large doses, KYZATREX may lower your sperm count.
Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
Swelling of your ankles, feet, or body (edema), with or without heart failure.
Enlarged or painful breasts.
Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by visiting www.mariuspharma.com.

Keep KYZATREX and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX.

References:

KYZATREX [prescribing information]. Raleigh, NC: Marius Pharmaceuticals; 2022.
Data on file. Raleigh, NC: Marius Pharmaceuticals, 2020.
“Hypogonadism in Men.” Endocrine Society, 31 Mar. 2022, www.endocrine.org/patient-engagement/endocrine-library/hypogonadism.
Shores MM, Sloan KL, Matsumoto AM, et al. Increased incidence of diagnosed depressive illness in hypogonadal older men. Arch Gen Psychiatry. 2004;61(2):162–167.

Media Contact

Marius Pharmaceuticals
Lilly Washburn
lilly@mariuspharma.com

News

nuBioAge, nuHx and Marius Pharmaceuticals Team Up for Collaborative GLP-1 Comparison Study in Male Patients

WEST PALM BEACH, Fla., Sept. 25, 2024 /PRNewswire/ — nuBioAge, a longevity science and wellness network based in West Palm Beach, has announced a partnership between their new comprehensive assessment and research center, nuHx, and Marius Pharmaceuticals, the company behind KYZATREX® (testosterone undecanoate) CIII capsules, an FDA-approved oral testosterone treatment for men. Together, they aim to conduct a pioneering study that will measure the impact of GLP-1s on muscle mass in male patients using the treatment for weight loss.

In conjunction with muscle mass reduction being a known and documented side effect of GLP-1s, a decrease in energy levels and overall strength has been linked to men participating in GLP-1 therapies.¹ While these reductions have been documented, there is currently no supportive treatment available for men struggling to maintain muscle mass and energy levels during GLP-1 therapy. nuHx and Marius Pharmaceuticals are partnering up to not only prove the cause-and-effect relationship between muscle mass reduction and energy loss as it relates to GLP-1s but also develop a first-of-its-kind treatment that leverages testosterone to counteract these effects and promote muscle growth during weight loss therapy.

Marius Pharmaceuticals will supply KYZATREX for this study in partnership with nuBioAge, who is responsible for assembling the study and data interpretation alongside nuHx, who will be performing the ongoing assessments for the patients participating in the study. Patients will be recruited and supplied with medication through Progress Pharmacy, with study design and data analytics supported by Palm Beach Atlantic University’s School of Pharmacy. Bryan Gard, PA-C, head of Gard Wellness Solutions, will oversee patient care as the lead specialist in Hormone Replacement Therapy (HRT) and weight loss.

This study is designed to evaluate how GLP-1 therapy combined with KYZATREX® impacts muscle mass and energy levels in male patients undergoing weight loss. By assessing key metrics such as muscle mass retention, testosterone levels, and VO2 max using advanced biomarker tools like PNOE, Dexascan, and other lab-based methods, the study aims to provide comprehensive insights. nuHx offers a full spectrum of health assessments, making it the ideal setting to track and monitor these effects in male patients on GLP-1 therapy.

“GLP-1s are one of the most revolutionary therapies we have to treat obesity and overall metabolic disorders,” said Franck Kacou, PharmD, co-owner of nuBioAge and Head Pharmacist at Progress Pharmacy. We can enhance the positive benefits of weight loss by improving Body Mass Index (BMI) and body composition in male patients to maintain muscle mass, strength, and energy levels through proper biomarker monitoring and TRT. As a result, we can directly impact and improve a patient’s healthspan, quality of life, and longevity plan.”

To further support the link between GLP-1s and muscle loss, a recent study showed that those taking Semaglutide lost on average 60% fat and 39% muscle mass. Patients on Tirzapetide lost roughly 25% muscle and 75% fat during treatment.² In addition, lower levels of skeletal muscle mass (SMM) and physical strength performance have been linked to a higher risk of cardiovascular disease (CVD) as well as a higher risk of “all-cause mortality” over those with adequate muscle mass.³ To counteract muscle mass reduction, testosterone has proven for years it’s link to muscle mass retention and growth through protein synthesis, making it a potential treatment solution for male GLP-1 patients.⁴

“This collaboration represents an exciting intersection of weight loss and testosterone therapy. By combining the benefits of GLP-1s with the muscle-building potential of testosterone, we believe we can offer a truly comprehensive approach to men’s health,” said Shalin Shah, CEO of Marius Pharmaceuticals. “Our goal is to ensure that men not only achieve weight loss but also maintain the strength and energy they need for a healthy life.”

The study is set to start December 2024 at the nuHx headquarters in West Palm Beach and conclude May 2025 with published study results to follow. nuBioAge and its partner network will continue to pioneer unique studies like this one to contribute to the ongoing accessibility of physician education and knowledge in longevity treatment.

About nuBioAge

nuBioAge is a longevity science and wellness education network serving medical practitioners and allied health professionals focused on delivering patient-centric, evidence-based longevity medicine. With its comprehensive ecosystem of resources, nuBioAge empowers practitioners to leverage advanced pharmacy networks, state-of-the-art assessments and data, and leading longevity research, education and clinical implementation.

Physician-focused, science-backed, and dedicated to advancing transparent practices, nuBioAge is the go-to hub for practitioners committed to delivering clinical longevity medicine for improved healthspan and lifespan outcomes.For more information on how nuBioAge is redefining the future of longevity science, visit www.nubioage.com

About nuHx

nuHx is an extensive health assessment experience focused on whole body analysis through advanced biomarker testing and reporting. Their reporting results inform and assist physicians in crafting individual patient treatment plans that are based on a patients full health story rather than it’s parts. Through their advanced testing, nuHx is able to identify risks through evidence-based data leading to preventative treatment that ultimately improves and optimizes a patients healthspan and longevity plan. For more information on how nuHx is individualizing health assessment experiences, visit www.nuhx.health.

About Progress Pharmacy

Progress Pharmacy is an independent pharmacy in West Palm Beach, Florida committed to providing personalized clinical care to patients seeking natural health and wellness alternatives and pharmacology solutions. With specific pharmacy clinicians trained in counseling each patient population, they aim to help patients find the right medicine for their health condition while working alongside research partners to develop expertly crafted compounds and therapies to best serve their market. For more information on how Progress Pharmacy is enhancing their patients quality of life through modern, personalized medicine, visit www.progresspharmacy.com

About Marius Pharmaceuticals

Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company’s vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.

About KYZATREX® (testosterone undecanoate)

KYZATREX® is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX® was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX® achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX® reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX® patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX® in males less than 18 years old have not been established.

Please see additional Important Safety Information for KYZATREX® below, including Boxed Warning for potential increased blood pressure, or visit www.kyzatrex.com.

Important Safety Information for KYZATREX^® (testosterone undecanoate)

Use
KYZATREX^® (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions.

KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.

Important Safety Information for KYZATREX^®

KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
If your blood pressure cannot be controlled, KYZATREX may need to be stopped.
Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX.

Do not take KYZATREX if you:have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).

Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you:have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX may cause other serious side effects including:

Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.
If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX.These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
Increased risk of prostate cancer.
Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
In large doses, KYZATREX may lower your sperm count.
Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
Swelling of your ankles, feet, or body (edema), with or without heart failure.
Enlarged or painful breasts.
Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by visiting www.mariuspharma.com.

Keep KYZATREX and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX.

References:

Sargeant, J. A., Henson, J., King, J. A., Yates, T., Khunti, K., & Davies, M. J. (2019). A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors on Lean Body Mass in Humans. Endocrinology and Metabolism, 34(3), 247-262. https://doi.org/10.3803/EnM.2019.34.3.247
Rodriguez, P. J., Goodwin Cartwright, B. M., Gratzl, S., Brar, R., Baker, C., Gluckman, T. J., & Stucky, N. L. (2024). Semaglutide vs Tirzepatide for Weight Loss in Adults With Overweight or Obesity. JAMA Internal Medicine, 184(9), 1056-1064. https://doi.org/10.1001/jamainternmed.2024.2525
Srikanthan, P., & Karlamangla, A. S. (2014). Muscle Mass Index as a Predictor of Longevity in Older-Adults. The American Journal of Medicine, 127(6), 547. https://doi.org/10.1016/j.amjmed.2014.02.007
Griggs RC, Kingston W, Jozefowicz RF, Herr BE, Forbes G, Halliday D. Effect of testosterone on muscle mass and muscle protein synthesis. J Appl Physiol (1985). 1989 Jan;66(1):498-503. doi: 10.1152/jappl.1989.66.1.498. PMID: 2917954.

Contact Information:

Hayden Collier
hayden@nuhx.health
www.nuhx.health

Marius Pharmaceuticals
Lilly Washburn
lilly@mariuspharma.com

SOURCE NUBIOAGE LLC

News

MARIUS PHARMACEUTICALS ANNOUNCES ISSUANCE OF TWO KEY PATENTS PROTECTING ITS PROPRIETARY ORAL TESTOSTERONE THERAPY

RALEIGH, N.C., May 21, 2020 (GLOBE NEWSWIRE) — Marius Pharmaceuticals announced today that the United States Patent and Trademark Office (USPTO) has issued two key patents related to its lead asset, Kyzatrex®*. Kyzatrex® is an oral Testosterone Replacement Therapy (TRT) that uses an innovative formulation to improve effectiveness and safety.

These allowed claims will provide strong IP protection to December 2030, over 8 years of potential commercial runway. They supplement Marius Pharmaceuticals’ already robust global patent portfolio for Kyzatrex®, which includes granted patents in the European Union, Canada, China, Taiwan, Japan, New Zealand and other key markets, and pending applications in India, and US. Marius Pharmaceuticals’ patent portfolio includes filings that extend protection to 2033, with the potential to extend protection out to 2040.

The allowed claims protect Kyzatrex®, an innovative formulation designed to increase bioavailability and provide a favorable pharmacokinetic (PK) profile compared to other therapeutic alternatives. Om Dhingra, Chief Executive Officer of Marius commented “This innovation is truly exceptional as we have created a formulation with a unique PK profile which we believe drives important clinical significance.”

Marius Pharmaceuticals’ Chief Financial Officer Shalin Shah said “We are very pleased to strengthen the intellectual property portfolio for Kyzatrex® and excited that it has tremendous potential to be differentiated and unique option in the TRT space. We are also drawing a line in the sand between a new treatment paradigm and old testosterone therapies.”

Marius Pharmaceuticals has recently completed its pivotal Phase 3 study for Kyzatrex® and intends to submit its New Drug Application (NDA) to the Food & Drug Administration (FDA).

About Kyzatrex®

Kyzatrex® is an experimental therapy for the treatment of primary and secondary hypogonadism (congenital or acquired). Testosterone is a crucial hormone that plays key roles in human growth and development and a wide range of other functions including metabolic and cardiovascular. Sources estimate that 15 million men in the United States suffer from hypogonadism, but only approximately 10% are currently treated. The co-morbidities of men suffering from hypogonadism are also a significant burden on patients and the healthcare system, these include Type 2 Diabetes and other serious chronic conditions.

Current marketed treatments are dominated by painful injections and messy topical applications with transference risk. Kyzatrex® is an orally administered therapy, which avoids those drawbacks. Market research points to 93% of patients indicating they would ask their physician about Kyzatrex® and more than half would consider a switch from their current regimen.

About Marius Pharmaceuticals

Marius pharmaceuticals is a cutting-edge biopharma company focusing on treating widespread conditions that have been triggered primarily through Androgen deficiency. Our pipeline consists of assets focused on inflammation while our commercial arm is at the forefront of data science technologies core to our commercialization of our lead asset Kyzatrex®.

*Kyzatrex is a tentative Tradename currently under review with the FDA

For more information, contact:

Shalin Shah

shalin@mariuspharma.com

News

MARIUS PHARMACEUTICALS ANNOUNCES CO-CEOS HIMANSHU H. SHAH AND SHALIN SHAH TO DRIVE GROWTH AHEAD OF ANTICIPATED FDA ACTION OF ITS LEAD ASSET, KYZATREX

January 27, 2021

RALEIGH, N.C., January 28, 2021 – Marius Pharmaceuticals, a specialty pharmaceutical company focusing on treating conditions that are primarily associated with testosterone deficiency, today announced that it has appointed Himanshu H. Shah and Shalin Shah as co-CEOs to drive the next phase of growth as the company looks to a potential launch of KYZATREX® in Q4 2021 and further the development of Marius’ deep clinical pipeline.

Himanshu H. Shah brings over 30 years of experience across global capital markets and will continue his role as chairman of the board in addition to co-CEO. He has advised numerous public and private companies over the past decades to help them unlock substantial shareholder value and execute both innovative and pragmatic business strategies.

“I am proud to continue serving Marius and work on developing the best treatment options for men with hypogonadism, a common but not widely discussed disease among patients and prescribers,” said Himanshu H. Shah, chairman and co-CEO of Marius Pharmaceuticals. “Misconceptions about hypogonadism are having a huge impact on the health of millions of men globally and costing the U.S. healthcare system alone billions of dollars annually. There is a huge opportunity for Marius to address these issues and drastically alter the testosterone therapy landscape.”

Shalin Shah will also step into the role of co-CEO from chief financial officer and executive vice president of strategy for Marius. Shalin has been integral in driving overall strategy at Marius for the past four years and will oversee the growth of the team and execution of innovative models as it expands both clinically and commercially to become a leading pharmaceutical company.

“I am excited for the opportunity to serve Marius in this new capacity, especially at a time when the world is seeing technology and healthcare intersect more than ever, truly helping patients,” said Shalin Shah, co-CEO of Marius Pharmaceuticals. “I am confident in Marius’ mission to better the lives of patients by ensuring adequate levels of testosterone and enhance patient care through disruptive technologies and personalization.”

Om Dhingra, Ph.D., led the company from initial development of the lead compound through two successful Phase 3 clinical trials and will move into the role of vice chairman. He will help guide the company’s clinical development plan and ensure KYZATREX® and its differentiating safety and efficacy data is well known in the medical world.

“It has been my great pleasure serving the company as CEO. I am very proud of the data we have generated, which we believe will position KYZATREX® as the standard of care for patients suffering from hypogonadism globally,” said Dr. Om Dhingra, vice chairman of Marius Pharmaceuticals.

If approved by the FDA, KYZATREX® has the potential to become the new standard of care for treating patients with hypogonadism. Testosterone is a crucial hormone that is essential to sexual and reproductive health, but also has important functions in metabolic, inflammatory, cardiovascular and neurological health. In the U.S. there are at least six million symptomatic men suffering from hypogonadism, and over 100 million men globally. The resulting medical costs associated with men with untreated hypogonadism and related comorbidities are more than $25 billion in the U.S. alone. Current treatments on the market are dominated by therapies with unappealing administration methods, including auto-injections, in-office infusions and topical gels and creams that have a high transference risk. KYZATREX® is an orally administered treatment that avoids the drawbacks that keep men from continuing treatment on available testosterone therapies.

About KYZATREX®

KYZATREX® if approved, will represent a novel oral testosterone replacement therapy option for adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

The ReTUNE™ study was a multi-center, 12-month study across the U.S. that studied the safety and efficacy of KYZATREX® in hypogonadal subjects (total testosterone ≤ 281 ng/dL). Efficacy was determined by number of subjects in the normal, eugonadal range after 90 days of treatment, including dose titrations, while safety was monitored for a further 9 months while on a steady dose. In addition to testosterone parameters, the study collected Patient Reported Outcomes (PROs), which showed statistically significant results both from baseline and against its comparator. A pivotal six-month Phase 3 study was conducted, in which subjects were monitored using ABPM, now considered the standard BP assessment by the FDA and clinical experts. An improved dose regimen was also used in the pivotal six-month Phase 3 study. The results of the Phase 3 studies will be published in leading medical journals and presented at national conferences in 2021.

The FDA has conditionally accepted KYZATREX® as the trade name for this investigational drug. The safety and efficacy have not been fully evaluated by any regulatory authority.

About Marius Pharmaceuticals

Marius is a specialty pharmaceutical company focusing on treating conditions that are primarily associated with hypogonadism, commonly referred to as testosterone deficiency. The company’s mission is to improve the functional lives of patients and reduce the risks of the downstream effects of endocrine imbalance by ensuring appropriate level of testosterone. For more information, please visit www.mariuspharma.com .

Contact:

Emily Brice

919-610-3319

ebrice@fwv-us.com

News

Marius Announces Ambulatory Blood Pressure Results Published in the Journal of Clinical Hypertension with their new testosterone medication KYZATREX™

RALEIGH, N.C., June 11, 2021 —Marius Pharmaceuticals, a patient-centric healthcare company focusing on therapies designed for hypogonadism, more commonly known as testosterone deficiency, today announced the publication of a study on the effects of oral testosterone undecanoate KYZATREX™ on ambulatory blood pressure in hypogonadal men in The Journal of Clinical Hypertension.

“Effects of Oral Testosterone Undecanoate KYZATREX™ on Ambulatory Blood Pressure in Hypogonadal Men”was published by William B. White, M.D., Professor, Cardiology Center, University of Connecticut School of Medicine, Farmington, and former President of the Hypertension Society of North America, Roger Rittmaster, MD, an endocrinologist in Camden, Maine, and Om Dhingra and James Bernstein from Marius. This newly published study shows small increases in ambulatory BP following 120 days on the oral testosterone undecanoate with a plateau and no further changes at 180 days. Changes in ambulatory BP were minimal in patients not taking antihypertensive therapies.

The publication of these results marks a significant milestone in the field of testosterone therapy as ambulatory blood pressure monitoring (ABPM) is the most accurate means to detect small BP changes in clinical trials and practice. Lead author William B. White, M.D. commented, “The changes in ambulatory BP were quite minimal in our study and of no clinical significance in normotensive men, a first in the testosterone space.” As testosterone therapy evolves past injections and gels towards the oral formulations, it is important to determine off-target effects on BP and to be able to compare these effects across the various therapies. Shalin Shah, Co-CEO of Marius commented, “We are extremely proud of the blood pressure data produced across all patient groups. If approved by the FDA, KYZATREX™ has the potential to provide greater clarity to both the physician and patient community on expected blood pressure changes.”

About KYZATREX™

KYZATREX™, if approved, will represent a novel oral testosterone replacement therapy option for adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

The ReTUNE™ study was a multi-center, 12-month study across the U.S. that studied the safety and efficacy of KYZATREX™ in hypogonadal subjects (total testosterone ≤ 281 ng/dL). Efficacy was determined by number of subjects in the normal, eugonadal range after 90 days of treatment, including dose, titrations, while safety was monitored for a further 9 months while on a steady dose. In addition to testosterone parameters, the study collected Patient Reported Outcomes (PROs), which showed statistically significant results both from baseline and against its comparator. A pivotal six-month Phase 3 study was conducted, in which subjects were monitored using ABPM, now considered the standard BP assessment by the FDA and clinical experts. An improved dose regimen was also used in the pivotal six-month Phase 3 study. The results of the Phase 3 studies will be published in leading medical journals and presented at national conferences during 2021.

The FDA has conditionally accepted KYZATREX™ as the trade name for this investigational drug. The safety and efficacy have not been fully evaluated by any regulatory authority.

About Testosterone and Hypogonadism

Hypogonadism, often referred to as testosterone deficiency, is a condition that occurs when the body does not produce adequate levels of testosterone. In addition to testosterone’s widely accepted role in sexual and reproductive function, it also has important roles in numerous other metabolic and inflammatory processes. In the U.S. there are at least six million symptomatic men suffering from hypogonadism, and over 100 million men globally. The resulting medical costs associated with men with untreated hypogonadism and related comorbidities are more than $25 billion in the U.S. alone.

Hypogonadism is also the most common cause of secondary osteoporosis in men. Beyond these diseases, hypogonadism is a common comorbidity in a broader set of conditions from Type-2 diabetes to Non-Alcoholic Steatohepatitis (NASH).

About Marius Pharmaceuticals

Marius is a patient-centric healthcare company focusing on therapies designed for hypogonadism or testosterone deficiency. The company’s mission is to improve the functional lives of patients by reducing the downstream effects of testosterone deficiency which include increased inflammation and fatigue. For more information, please visit www.mariuspharma.com

Study: Effects of Oral Testosterone Undecanoate KYZATREX™ on Ambulatory Blood Pressure in Hypogonadal Men

Contact:Lilly Washburn

336-404-9622

lilly@mariuspharma.com

News

Marius Pharmaceuticals Partners with UK-Based Numan to Combat Testosterone Deficiency with KYZATREX® (Testosterone Undecanoate) CIII Capsules

RALEIGH, N.C., September 18, 2024 — Marius Pharmaceuticals is pleased to announce a new partnership with Numan, a leading UK-based, VC-backed digital health platform, to introduce KYZATREX® (testosterone undecanoate) CIII capsules into Numan’s product offerings. KYZATREX is FDA-approved in the US and is indicated for adult men who have low or no testosterone due to certain medical conditions. This collaboration marks a significant step forward in the treatment of testosterone deficiency, offering men a more comprehensive and patient-centered solution for managing this common yet often overlooked condition.

Testosterone deficiency (TD) is a rising global epidemic, affecting approximately four in ten men over the age of 45 and 30-50% of men with obesity or type 2 diabetes, according to the Endocrine Society.^1,2 In the UK alone, it is estimated that around 3 million men suffer from testosterone deficiency, with around 90% of those cases remaining untreated.^3-5 TD is bi-directional with metabolic diseases, and early research suggests it may play a role in further conditions such as depression and inflammatory diseases. As these health issues continue to escalate, the partnership between Marius Pharmaceuticals and Numan marks a collaborative effort to position KYZATREX as a promising solution in the fight against this widespread medical condition.

“We are thrilled to partner with Numan and expand the availability of KYZATREX to patients in the UK,” said Amit Shah, Chief Operating Officer at Marius. “Testosterone deficiency is a global health issue, and our collaboration allows us to offer men a therapy that is not only effective but also designed with patient safety in mind. By joining forces with a trusted health platform like Numan, we’re confident that more men will have access to the care they need to improve their overall health and well-being.”

KYZATREX has been specifically formulated to be gentle on the body, bypassing the liver to prevent potential liver damage, a common concern with other forms of testosterone therapy. In a six-month clinical trial involving 139 men with low testosterone, 88% of KYZATREX patients achieved normal testosterone levels by Day 90 (worst-case scenario calculation, excluding Site 104). For patients who completed the study (n=127), this number rose to 96%. Furthermore, KYZATREX patients experienced a twofold increase in Free Testosterone levels and a 30% reduction in Sex Hormone Binding Globulin (SHBG) levels.^6-8

Numan, already a leader in the medical weight loss space in the UK, brings a unique, patient-focused approach to testosterone therapy. Their process includes a holistic, guideline-led diagnosis using gold-standard blood testing and expert analysis. By integrating KYZATREX into their offerings, Numan continues to expand its commitment to men’s health, delivering tailored treatment programs that address the root causes of testosterone deficiency and support overall wellbeing.

About Marius Pharmaceuticals

Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company’s vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.

About KYZATREX^® (Testosterone Undecanoate)

KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) and indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in symptoms of low testosterone, including quality of life, energy/fatigue, erectile function, sexual intercourse, and mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established.

Please see additional Important Safety Information for KYZATREX below, including Boxed Warning for potential increased blood pressure, or visit www.kyzatrex.com.

Important Safety Information for KYZATREX^® (testosterone undecanoate)

Use
KYZATREX^® (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions.

KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.

Important Safety Information for KYZATREX^®

KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
If your blood pressure cannot be controlled, KYZATREX may need to be stopped.
Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX.

Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).

Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX may cause other serious side effects including:

Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.
If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
Increased risk of prostate cancer.
Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
In large doses, KYZATREX may lower your sperm count.
Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
Swelling of your ankles, feet, or body (edema), with or without heart failure.
Enlarged or painful breasts.
Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by visiting www.mariuspharma.com.

Keep KYZATREX and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX.

References:

Mulligan T et al. “Prevalence of hypogonadism in males aged at least 45 years: the HIM study.” International journal of clinical practice vol. 60,7 (2006): 762-9. doi:10.1111/j.1742-1241.2006.00992.x.
“Hypogonadism in Men.” Endocrine Society, Endocrine Society, 31 Mar. 2022, www.endocrine.org/patient-engagement/endocrine-library/hypogonadism.
Hackett, Geoffrey et al. “The British Society for Sexual Medicine Guidelines on Male Adult Testosterone Deficiency, with Statements for Practice.” The world journal of men’s health vol. 41,3 (2023): 508-537. doi:10.5534/wjmh.221027
“England Population by Age Group 2022.” Statista, 4 July 2024, www.statista.com/statistics/281208/population-of-the-england-by-age-group/.
Layton, J Bradley et al. “Testosterone lab testing and initiation in the United Kingdom and the United States, 2000 to 2011.” The Journal of clinical endocrinology and metabolism vol. 99,3 (2014): 835-42. doi:10.1210/jc.2013-3570
Bernstein JS, Dhingra OP. A Phase III, Single-Arm, 6-Month Trial of a Wide-Dose Range Oral Testosterone Undecanoate Product. Therapeutic Advances in Urology. 2024;16.
KYZATREX [prescribing information]. Raleigh, NC: Marius Pharmaceuticals; 2022.
Data on file. Raleigh, NC: Marius Pharmaceuticals, 2020.

Media Contacts:

Marius Pharmaceuticals
Lilly Washburn
lilly@mariuspharma.com

News

The Vitamin Shoppe® Expands its Whole Health Rx™ Telehealth Offering into Testosterone Replacement Therapy via a Partnership with Marius Pharmaceuticals for its KYZATREX® (Testosterone Undecanoate) CIII Capsules

The new partnership offers trusted and convenient telehealth access to treatment for the millions of American men who experience testosterone deficiency and may be appropriate patients for KYZATREX

SECAUCUS, N.J., September 3, 2024 /PR Newswire/ — The Vitamin Shoppe®, an omni-channel specialty retailer of nutritional products, today announced the expansion of its telehealth service, Whole Health Rx™ by The Vitamin Shoppe, with the launch of prescription Testosterone Replacement Therapy (TRT) solutions. Partnering with Marius Pharmaceuticals, Whole Health Rx now provides access to FDA-approved KYZATREX® (testosterone undecanoate) CIII capsules, a prescription medication for adult men who have low or no testosterone due to certain medical conditions. KYZATREX is available in an oral form, providing a non-invasive and convenient alternative to traditional injection-based methods.

Whole Health Rx is an innovative telehealth service from The Vitamin Shoppe that offers a holistic approach to health solutions, encompassing prescription medications, nutritional supplements for whole-body health, and expert guidance on lifestyle practices to support lifelong wellness. The service launched in May 2024, with an initial focus on GLP-1 agonist medications for weight loss.

Whole Health Rx enables access to a virtual care platform, powered by WellSync, which safely and seamlessly connects patients with licensed healthcare providers in real time, delivering a high standard of personalized care and prescription medications, with lower costs and greater convenience for patients.

Lee Wright, CEO of The Vitamin Shoppe, commented, “Men’s health and testosterone support has been a category of growing interest to our customers, so we’re especially pleased to now offer the highly effective and easy-to-use KYZATREX prescription medication to Whole Health Rx patients who can benefit from TRT. Our mission is to grow Whole Health Rx into a full-service health solution provider that can meet more of our customers’ wellness needs, building on our strategic partnership with WellSync’s innovative telehealth platform and expert network of healthcare professionals and pharmacies. As a pioneer in the wellness space since 1977, The Vitamin Shoppe is uniquely positioned to unite pharmaceutical interventions, such as TRT, with our unmatched expertise in nutrition support and whole-body health.”

The launch of TRT on Whole Health Rx comes at a time when there are an estimated 20 million American men who experience Testosterone Deficiency (TD), or hypogonadism. TD is a rising global epidemic as it affects approximately four in ten men older than 45 years and 30-50% of men with obesity or type 2 diabetes, according to the Endocrine Society.^1,2 Between 10% and 40% of men worldwide suffer from low testosterone levels.³Testosterone deficiency is bi-directional with metabolic diseases and early research indicates a role in further conditions such as depression and inflammatory diseases.

“Testosterone Replacement Therapy can significantly improve energy levels, muscle mass, and libido in males with a diagnosed deficiency in their testosterone levels. It helps enhance mood, cognitive function, and overall well-being. Additionally, TRT can aid in reducing the risks of cardiovascular diseases by maintaining optimal hormone levels,” said Mutahir Farhan, MD, a member of The Vitamin Shoppe’s Wellness Council.

While TRT has traditionally consisted of injections, implanted pellets, patches, or gels, KYZATREX instead delivers testosterone through a twice-daily, softgel capsule that is safe and convenient. The oral delivery excludes the administration pain, mess, transference risk to others around you, and changes to eating habits which can occur with other TRT delivery systems. KYZATREX is primarily absorbed via the lymphatic system, effectively bypassing the liver and avoiding toxicity.

Shalin Shah, CEO of Marius Pharmaceuticals, commented, “We are excited that The Vitamin Shoppe is expanding Whole Health Rx to include KYZATREX, offering men a convenient and effective treatment for low testosterone. The data demonstrates that KYZATREX not only provides a safe and effective form of testosterone replacement therapy, but also decreases sex hormone-binding globulin (SHBG) and increases free testosterone levels in the body. By combining the convenience of our oral delivery system with the benefits of testosterone undecanoate, we believe KYZATREX can be transformative for men suffering from testosterone deficiency, addressing the significant drop in testosterone levels among men in the United States over the past few decades.”

In a six-month clinical trial of 139 men with low testosterone, 88% of KYZATREX patients had normal testosterone levels at Day 90 (worst-case scenario calculation, excluding Site 104). Based on patients who completed the study (n=127), 96% of patients achieved normal testosterone levels at Day 90. Critically, KYZATREX patients also had a 2x increase in Free Testosterone levels and a 30% decrease in Sex Hormone Binding Globulin (SHBG) levels.^4-6

In a separate clinical study, KYZATREX patients (n=214) reported improvements in energy, positive mood, sexual desire, intercourse satisfaction, and social functioning, among other factors, as a result of improved testosterone levels compared to baseline.⁶(Exploratory endpoints from Study MRS-TU-2019; Different dosing scheme than MRS-TU-2019EXT. Results may not be clinically significant.)

Whole Health Rx patients are required to complete a medical history questionnaire and diagnostic blood tests, as well as meet virtually with a medical provider, to determine eligibility for a KYZATREX prescription. If approved for a prescription, orders will be easily and quickly fulfilled through Whole Health Rx’s pharmacy partners and delivered in the mail.

Many men looking into TRT share common health factors, from diet and sleep issues to strength training and longevity goals. As a complement to TRT, Whole Health Rx includes easy access to education about lifestyle changes and proper nutrition that can support these kinds of whole-body health goals, as well as nutritionist-approved supplement options such as proteins, creatine, prostate support, and multivitamins.

For more information about TRT and Whole Health Rx by The Vitamin Shoppe, visit www.vitaminshoppe.com/lp/trt. For more information about KYZATREX, visit www.kyzatrex.com, and for more information about Marius Pharmaceuticals, visit www.mariuspharma.com.

About The Vitamin Shoppe®

Lifelong Wellness Starts Here™. The Vitamin Shoppe®, a subsidiary of Franchise Group, Inc., is a global, omnichannel specialty retailer and wellness lifestyle Company with the mission of providing customers with the most trusted products, guidance, and services to support them on their journeys of lifelong wellness. Based in Secaucus, New Jersey, the Company offers a comprehensive assortment of nutritional solutions, including vitamins, minerals, sports nutrition, specialty supplements, herbs, homeopathic remedies, and green living products. In addition to carrying products from approximately 700 national brands, The Vitamin Shoppe offers products from its proprietary brands within its owned and wholesale channels, including: The Vitamin Shoppe®, Vthrive The Vitamin Shoppe®, BodyTech®, BodyTech® Elite, fitfactor™, fitfactor KETO™, plnt®, ProBioCare®, True Athlete®, and TrueYou™. In the U.S., the Company conducts business through approximately 700 company-operated and franchise retail stores under The Vitamin Shoppe and Super Supplements™ banners, and via its website, www.vitaminshoppe.com. Globally, The Vitamin Shoppe serves customers in select Asia, South America, and Central America markets through local omnichannel partners.

About Marius Pharmaceuticals

Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company’s vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.

About WellSync

WellSync is a leader in healthcare innovation, revolutionizing the connection between providers and patients through our transformative, virtual-first platform. By leveraging advanced integrated technology, we seamlessly embed clinical and medication fulfillment services into any online environment. Our scalable, API-driven solution empowers companies to incorporate virtual healthcare services directly into their existing digital presence, enhancing patient access and unlocking new revenue streams. Our versatile platform stands out by its accessibility, personalization, and streamlined integration, supported by teams of top-tier healthcare professionals—including board-certified physicians, licensed specialists, and nurse practitioners—who bring extensive expertise and an unwavering commitment to exceptional patient care. Their dedication ensures our platform continually adapts to meet the ever-changing demands of healthcare in today’s virtual landscape. WellSync isn’t just redefining healthcare delivery, we’re pioneering the future of digital health partnerships.

About KYZATREX^® (Testosterone Undecanoate)

KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) and indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in symptoms of low testosterone, including quality of life, energy/fatigue, erectile function, sexual intercourse, and mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established.

Please see additional Important Safety Information for KYZATREX below, including Boxed Warning for potential increased blood pressure, or visit www.kyzatrex.com.

Important Safety Information for KYZATREX^® (Testosterone Undecanoate Capsules)

Use
KYZATREX^® (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions.

KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.

Important Safety Information for KYZATREX^®

KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
If your blood pressure cannot be controlled, KYZATREX may need to be stopped.
Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX.

Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).

Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX may cause other serious side effects including:

Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.
If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
Increased risk of prostate cancer.
Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
In large doses, KYZATREX may lower your sperm count.
Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
Swelling of your ankles, feet, or body (edema), with or without heart failure.
Enlarged or painful breasts.
Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by visiting www.mariuspharma.com.

Keep KYZATREX and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX.

References:

Mulligan T et al. “Prevalence of hypogonadism in males aged at least 45 years: the HIM study.” International journal of clinical practice vol. 60,7 (2006): 762-9. doi:10.1111/j.1742-1241.2006.00992.x.
“Hypogonadism in Men.” Endocrine Society, Endocrine Society, 31 Mar. 2022, www.endocrine.org/patient-engagement/endocrine-library/hypogonadism.
Anaissie J et al. “Testosterone deficiency in adults and corresponding treatment patterns across the globe.” Translational andrology and urology vol. 6,2 (2017): 183-191. doi:10.21037/tau.2016.11.16
Bernstein JS, Dhingra OP. A Phase III, Single-Arm, 6-Month Trial of a Wide-Dose Range Oral Testosterone Undecanoate Product. Therapeutic Advances in Urology. 2024;16.
KYZATREX [prescribing information]. Raleigh, NC: Marius Pharmaceuticals; 2022.
Data on file. Raleigh, NC: Marius Pharmaceuticals, 2020.

Media Contacts:

David Lipke
Senior Director, Corporate Communications
david.lipke@vitaminshoppe.com

Nike Communications for The Vitamin Shoppe
Katie Lewis
klewis@nikecomm.com

Marius Pharmaceuticals
Lilly Washburn
lilly@mariuspharma.com

News

Marius Pharmaceuticals Submits KYZATREX® (Testosterone Undecanoate) CIII Capsules for Approval to Health Canada

RALEIGH, N.C., July 30, 2024 — Marius Pharmaceuticals, a patient-centric healthcare company focused on developing innovative therapies for Testosterone Deficiency, is pleased to announce the submission of its New Drug Submission (NDS) for KYZATREX® (testosterone undecanoate) CIII capsules to Health Canada for approval. This submission marks the company’s first international filing, with an anticipated approval date in Q2 of 2025.

KYZATREX is an oral testosterone replacement therapy designed to treat adult men with low or no testosterone levels due to certain medical conditions. KYZATREX offers a convenient and effective alternative in the form of a softgel capsule, which is absorbed primarily via the lymphatic system, thereby avoiding liver toxicity. If approved, KYZATREX could become the only oral testosterone option available in Canada. KYZATREX received U.S. FDA approval in July 2022.

“We are excited by this first international filing and look forward to helping more patients by broadening the availability of oral testosterone. Our goal is to provide men worldwide with access to effective, convenient treatment options for testosterone deficiency,” said Nita Nimmons, Director of Quality and Regulatory at Marius Pharmaceuticals. “Testosterone is a critical metabolic hormone that is crucial for many functions in the body. We hope that by increasing access to KYZATREX, we can become part of a solution to what has become a worldwide men’s health crisis.”

KYZATREX Clinical Trial Highlights:

Up to 96% Efficacy1
In a six-month clinical trial of 139 men with low testosterone, 88% of patients had normal testosterone levels at Day 90 (worst-case scenario calculation, excluding Site 104). Based on patients who completed the study (n=127), 96% of patients achieved normal testosterone levels at Day 90.1
Safety Profile
Only one drug-related adverse event was observed in more than 2% of study participants: hypertension (2.6%).1
2x Increase in Free Testosterone1
Mean Free Testosterone levels increased from 7.0 ng/dL to 14.1 ng/dL after 90 days of treatment.

The Impact of Low Testosterone on Men’s Health in Canada
Testosterone deficiency, or hypogonadism, is a chronic condition that affects over twenty million men in the United States and millions more worldwide.2,3 In Canada, the prevalence of testosterone deficiency is significant. Approximately 25% of Canadian men aged 40–62 years are estimated to have testosterone deficiency, with rates increasing with age.4 Moreover, the Canadian Men’s Health Foundation reports that nearly 50% of Canadian men aged 40–88 experience erectile dysfunction, a condition often associated with low testosterone levels.5

Low testosterone is commonly associated with sexual health, but its impacts extend far beyond. It has significant effects on physical, cardiovascular, cognitive, and metabolic health, including obesity, type 2 diabetes, depression, osteoporosis, inflammation, and muscle wasting (sarcopenia). Addressing this condition effectively is crucial to improving the overall health and well-being of men, and reducing the broader healthcare burden.

“Marius anticipates that Canadian healthcare will mirror the advancements seen in American healthcare, particularly in the realms of health, wellness, and telehealth,” said Amit Shah, the COO of Marius Pharmaceuticals. “The introduction of KYZATREX into the Canadian market is poised to support this progressive vision, offering a comprehensive approach to addressing testosterone deficiency and enhancing the overall health of men.”

About KYZATREX® (testosterone undecanoate)
KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established.

Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX or visit www.kyzatrex.com.

About Marius Pharmaceuticals
Marius Pharmaceuticals strives to better the lives of men and women by focusing on therapies designed for hypogonadism or Testosterone Deficiency. Their vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.

Important Safety Information for KYZATREX® (testosterone undecanoate)

Use
KYZATREX (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.

Important Safety Information for KYZATREX® (testosterone undecanoate)

KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
If your blood pressure cannot be controlled, KYZATREX may need to be stopped.
Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX.

Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).

Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX may cause other serious side effects including:

Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.
If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
Increased risk of prostate cancer.
Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
In large doses, KYZATREX may lower your sperm count.
Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
Swelling of your ankles, feet, or body (edema), with or without heart failure.
Enlarged or painful breasts.
Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040.

Keep KYZATREX and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX.

References:

Bernstein JS, Dhingra O. “A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product.” Ther Adv Urol. 2024;16:1-17. 2024; doi:10.1177/17562872241241864
Yongchao L, Minghui L, et al. Increased risk of testosterone deficiency is associated with the systemic immune-inflammation index: a population-based cohort study. Front. Endocrinol. 13:975773. doi: 10.3389/fendo.2022.974773
National Population by Characteristics: 2020-2022. Annual Estimates of the Resident Population for Selected Age Groups by Sex for the United States: April 1, 2020 to July 1, 2022 (NC-EST2022-SYAEXN). U.S. Census Bureau. https://www.census.gov/data/tables/time-series/demo/popest/2020s-national-detail.html
Morley, J E et al. “Validation of a screening questionnaire for androgen deficiency in aging males.” Metabolism: clinical and experimental vol. 49,9 (2000): 1239-42. doi:10.1053/meta.2000.8625
“Erectile Dysfunction Info for Men: Causes, Prevention, Treatment.” Edited by Dr. Larry Goldenberg, Canadian Men’s Health Foundation, 28 Mar. 2024, menshealthfoundation.ca/mens-health-conditions/erectile-dysfunction/.

Media Contact:
Lilly Washburn
lilly@mariuspharma.com
(336) 404-9622

News

Marius Pharmaceuticals Announces Final Published Phase 3 Data from MRS-TU-2019EXT Studying the Safety and Efficacy of FDA-Approved KYZATREX® (testosterone undecanoate) CIII Capsules

RALEIGH, NC (April 11, 2024) — Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, today announced published results from MRS-TU-2019EXT, a six-month clinical trial of 139 men with low testosterone studying the safety and efficacy of its oral testosterone replacement therapy, KYZATREX^® (testosterone undecanoate) CIII Capsules in adult men with conditions associated with a deficiency or absence of endogenous testosterone. The data, published in Therapeutic Advances in Urology, demonstrated that KYZATREX was up to 96% effective at Day 90 at restoring normal testosterone levels in adult men who have low or no testosterone levels due to certain medical conditions.^1*

*Per label, 88% of patients had low testosterone levels at Day 90 (worst-case scenario calculation, excluding Site 104). Based on patients who completed the study (n=127), 96% of patients achieved normal testosterone levels at Day 90.¹

“The world is experiencing a crisis related to men’s health, and we firmly believe that oral testosterone in the form of KYZATREX has the potential to be a critical part of the solution,” said Shalin Shah, chief executive officer of Marius Pharmaceuticals. “Not only does the data demonstrate that KYZATREX is a safe and effective form of testosterone replacement therapy, but it also shows that KYZATREX is effective at decreasing the amount of sex hormone binding globulin (SHBG) and increasing the amount of free testosterone in the body. We believe combining the convenience of our oral delivery system with the testosterone-boosting benefits of testosterone undecanoate can be transformative for men suffering from testosterone deficiency and in helping to correct the substantial drop in testosterone levels among men in the United States over the past few decades.”

Select Results from MRS-TU-2019EXT
MRS-TU-2019EXT was a 6-month, open-label study involving 139 hypogonadal men (median age of 50 years; range 22 to 66 years). The primary efficacy endpoint was the percentage of KYZATREX-treated patients with mean plasma total testosterone concentration (Cavg) over 24-hours within the normal range of 222-800 ng/dL on the final pharmacokinetic visit of the study at Day 90. KYZATREX demonstrated the following:

Up to 96 Efficacy¹Per label, 88% of patients had low testosterone levels at Day 90 (worst-case scenario calculation, excluding Site 104). Based on patients who completed the study (n=127), 96% of patients achieved normal testosterone levels at Day 90.
Safety Profile
- After 120 days of treatment, the change in 24-hour mean systolic blood pressure from baseline was 1.7 mmHg (95% CI, 0.3 to 3.1). After 190 days of treatment the blood pressure change appeared stable with a mean increase of 1.8 mmHg (95% CI, 0.3 to 3.2).¹
- Only one drug-related adverse event was observed in more than 2% of study participants: hypertension (2%).¹
- The article notes that, “The reported mean increase in systolic BP (blood pressure) is the lowest of the label-reported BP increases for the three FDA-approved oral TU (testosterone undecanoate) products.”¹
2x Increase in Free Testosterone¹Mean Free Testosterone levels increased from 7.0 ng/dL to 14.1 ng/dL after 90 days of treatment.
Impact on FSH and LH
While both FSH (follicle stimulating hormone) and LH (luteinizing hormone), which are critical for sperm production and male fertility, both decreased after 90 and 180 days of KYZATREX treatment, levels did not drop to zero at either of the two post-Baseline visits.¹

The authors of the study were James S. Bernstein, PhD, and Om Dhingra, PhD, board director and scientific advisor to Marius Pharmaceuticals.

Om Dhingra commented, “The excellent safety and efficacy data can be attributable to KYZATREX’s innovative and elegant formulation. This formulation utilizes phytosterols as a first in a pharmaceutical product to help make safe and effective Oral Testosterone a reality. We have expanded the traditional framework, as well, when considering effects of SHBG and Free Testosterone, which potentially mark a new era in treatment focused on usable testosterone, not just total T. We look forward to this being the beginning of a broader research program to better understand and demonstrate real world benefits of testosterone as a metabolic hormone.”

Testosterone deficiency – or hypogonadism – is a chronic disease that affects about 30 percent of men aged 20 years and older.² In a 24-year study, researchers noted a substantial age-independent decline in testosterone levels among men in the U.S. Since the study’s inception in 1984, it was determined that men born in more recent years have lower testosterone levels than previous generations, with average levels declining by about 1% per year.³ Compounding the issue, it’s been reported that only 5-10% of men with low testosterone are being treated with testosterone replacement therapy (TRT).⁴

Historically, TRT has been administered through injections, pellets and gels. KYZATREX is designed to utilize lymphatic absorption to bypass first-pass metabolism to drive uptake and prevent liver damage. KYZATREX is an immediate-release formulation with twice-daily dosing that, when administered every 12 hours, closely mimics the diurnal rhythm of endogenous testosterone, as demonstrated by the pharmacokinetic data in the study article.¹

This published study is part of Marius Pharmaceuticals’ comprehensive effort to develop innovative therapies for testosterone deficiency. To learn more about KYZATREX^®, visit https://www.kyzatrex.com. To learn more about Marius Pharmaceuticals, visit https://www.mariuspharma.com.

The full journal article can be found here.

About KYZATREX^®(testosterone undecanoate)
KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established.

Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX or visit www.kyzatrex.com.

About Marius Pharmaceuticals
Marius Pharmaceuticals strives to better the lives of men and women by focusing on therapies designed for hypogonadism or Testosterone Deficiency. Their vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.

Important Safety Information for KYZATREX^®(testosterone undecanoate)

Use
KYZATREX (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.

Important Safety Information for KYZATREX^®(testosterone undecanoate)

KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
If your blood pressure cannot be controlled, KYZATREX may need to be stopped.
Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX.

Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).

Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX may cause other serious side effects including:

Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.
If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
Increased risk of prostate cancer.
Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
In large doses, KYZATREX may lower your sperm count.
Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
Swelling of your ankles, feet, or body (edema), with or without heart failure.
Enlarged or painful breasts.
Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.
These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040.

Keep KYZATREX and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX.

References:

Bernstein JS, Dhingra O. “A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product.” Ther Adv Urol. 2024;16:1-17. 2024; doi:10.1177/17562872241241864
Peterson MD, Belakovskiy A, McGrath R, Yarrow JF. Testosterone deficiency, weakness, and multimorbidity in men. Sci Rep. 2018;8(1):5897. doi:10.1038/s41598-018-24347-6
Thomas G. Travison TG, Araujo AB, O’Donnell AB, et al., Andre B. Araujo, Amy B. O’Donnell, Varant Kupelian, John B. McKinlay, A Population-Level Decline in Serum Testosterone Levels in American Men, J Clin Endocrinol Metab. January 2007, 92(1):196-202
Krakowsky Y, Grober E. Testosterone deficiency – Establishing a Biochemical Diagnosis. EJIFCC. 2015 Mar; 26(2): 105–113.PMID: 27683486; PMCID: PMC4975356. Accessed 9 Feb. 2024.

News

Marius Pharmaceuticals Announces Pilot Study Exploring the Effect of Its Oral Testosterone Therapy, KYZATREX® (CIII testosterone undecanoate capsules), on Male Fertility

Raleigh, N.C., (January 9, 2023) – Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, today announced it has initiated a pilot study to better understand the effect of oral testosterone replacement therapy, KYZATREX® (testosterone undecanoate), on spermatogenesis in adult males. KYZATREX is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

While it is generally accepted that TRT in males decreases spermatogenesis, which occurs through suppression of the hypothalamic-pituitary-gonadal axis, most data are derived from traditional routes of administration of TRT (eg, injections, patches, gels, implantable pellets, etc.). This study will be the first of its kind to specifically examine the effects of an oral TRT, like KYZATREX, on spermatogenesis. Importantly, the American Urological Association currently recommends that physicians prescribing TRT inform their patients of the risks of the therapy on fertility.

“We are eager to begin this new pilot study, as finding an option of TRT that does not reduce fertility in men would be a significant milestone in the field of andrology and society as a whole,” said Andrew Sun, M.D., Director at the Center for Men’s Health at Urology Partners of North Texas and Chief Medical Advisor for Marius Pharmaceuticals. “Too many men are suffering in silence from the effects of testosterone deficiency, and the results from this study could help us better understand the effects of oral TRT on spermatogenesis, which might potentially benefit a subset of men; those who are looking to start a family while still treating
their low T.”

Led by principal investigator Dr. Mohit Khera, Director of the Laboratory for Andrology Research Baylor College of Medicine, the study will enroll 20 male patients, ages 18-49 years old, who meet the American Urological Association’s criteria for hypogonadism and who have not previously used TRT. “Historically, testosterone products have been known to impair sperm production. Thus, many
young hypogonadal men planning to achieve a pregnancy are unable to use testosterone due to an increased risk of suppressing their sperm production,” said Dr. Khera. “Identifying testosterone therapy that could potentially not suppress sperm production would be a significant advancement in the way we treat these hypogonadal men.”

Participating patients will receive 200-400mg of KYZATREX BID for three months. Two semen analyses will be performed at baseline, one month, and three months, to assess any changes in each patient’s sperm count. Blood draws will also be taken at each of these timepoints to measure testosterone, hormones, lipids, and hematocrit. There will also be an additional blood draw two weeks after starting the therapy to support drug titration to reach therapeutic levels. Additionally, patients will receive the IIEF, PHQ-9, and SF36 questionnaires at baseline and at the conclusion of the study to assess symptoms of low testosterone.

This pilot study is part of Marius Pharmaceuticals’ comprehensive effort to develop innovative therapies for testosterone deficiency. To learn more about KYZATREX, visit https://www.kyzatrex.com. To learn more about Marius Pharmaceuticals, visit https://www.mariuspharma.com.

About KYZATREX® (testosterone undecanoate)
KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established.

Please see additional Important Safety Information for KYZATREX below, including Boxed Warning for potential increased blood pressure, or visit www.kyzatrex.com.

About Marius Pharmaceuticals
Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism of Testosterone Deficiency. The company’s vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.

Important Safety Information for KYZATREX® (testosterone undecanoate)

Use
KYZATREX (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children.
KYZATREX is not meant for use by women.

Important Safety Information for KYZATREX®
KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
If your blood pressure cannot be controlled, KYZATREX may need to be stopped.
Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX.

Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).

Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX may cause other serious side effects including:

Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.
If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
Increased risk of prostate cancer.
Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
In large doses, KYZATREX may lower your sperm count.
Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
Swelling of your ankles, feet, or body (edema), with or without heart failure.
Enlarged or painful breasts.
Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.
These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040.

Keep KYZATREX and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX.

Media Contact:
5W Public Relations
kyzatrex@5wpr.com
212-999-5585

News

Media Contact:
5W Public Relations
kyzatrex@5wpr.com
212-999-5585

Marius Pharmaceuticals Announces KYZATREX® (CIII testosterone undecanoate capsules) HERO Campaign, Empowering Men To ‘Be the Hero of Your Life Again’

Raleigh, N.C., (December 6th, 2023) – Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, today announces the launch of its KYZATREX® HERO campaign that aims to empower men to “Be the Hero of Your Life Again.” KYZATREX is an oral prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. The advertising campaign seeks to educate patients who are appropriate candidates for treatment and their physicians on how KYZATREX can help men restore testosterone levels to reinvigorate their natural vitality.

The world is currently facing a men’s health crisis: Men account for 69% of suicides, 10.8 million men globally are living with prostate cancer, and testicular cancer is the most common cancer among men aged 15-39.¹ Additionally, men’s testosterone levels are declining, with testosterone deficiency having a prevalence of 20% among adolescent and young adult males.² Research also indicates that nearly 40% of men over the age of 45 suffer from low testosterone, yet men may not realize the effect it can have on their overall health.³

Through the HERO campaign, Marius Pharmaceuticals wants to help men reveal their inner hero. One of the ways they can do that is to prioritize their own health. Marius believes that every man should be asking their healthcare provider to check their testosterone levels – specifically total testosterone, free testosterone, and sex hormone binding globulin (SHBG), which all contribute to a full understanding of a man’s comprehensive metabolic health. In a clinical efficacy study of 127 hypogonadal patients, 96% of patients taking KYZATREX had normal testosterone levels at Day 90. (Based on end of clinical study completers (n=127). Worst case scenario (WCS) was used as a basis for the assessment of primary efficacy endpoint per label. WCS efficacy calculation was 88%, excluding Site 104 (n=139)).⁴,⁵Mean free testosterone levels doubled in the same time period, while mean SHBG levels declined by 30%.⁵ The only adverse event seen in more than 2% of patients receiving KYZATREX in the clinical trials was hypertension (2.6% of patients).⁵

“We hope the HERO campaign will help raise awareness for what is possible with safe, effective, and convenient testosterone replacement therapy; how KYZATREX can help get hypogonadal men back to feeling like themselves again,” said Shalin Shah, CEO of Marius Pharmaceuticals. “Too many men are silently suffering the daily effects of Testosterone Deficiency, and we want to change that narrative by empowering them to be their own HERO, realizing how the responsible use of testosterone therapy can drive clinically beneficial outcomes for men living with Low T.”

The HERO campaign is a part of Marius Pharmaceuticals’ ongoing comprehensive effort to raise awareness about testosterone deficiency or hypogonadism. The company is committed to educating individuals, including veterans and active-duty service members, about the impact of low testosterone on overall health and well-being. The initiative continues to expand its content and resources to provide valuable information on this critical topic.

To learn more about the KYZATREX, visit www.kyzatrex.com.

About KYZATREX® (testosterone undecanoate)
KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established.

Please see additional Important Safety Information for KYZATREX below, including Boxed Warning for potential increased blood pressure, or visit www.kyzatrex.com.

About Marius Pharmaceuticals
Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism of Testosterone Deficiency. The company’s vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.

Important Safety Information for KYZATREX® (testosterone undecanoate)

Use
KYZATREX (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children.
KYZATREX is not meant for use by women.

Important Safety Information for KYZATREX®
KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
If your blood pressure cannot be controlled, KYZATREX may need to be stopped.
Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX.

Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).

Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX may cause other serious side effects including:

Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.
If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
Increased risk of prostate cancer.
Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
In large doses, KYZATREX may lower your sperm count.
Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
Swelling of your ankles, feet, or body (edema), with or without heart failure.
Enlarged or painful breasts.
Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.
These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040.

Keep KYZATREX and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX.

References:
1. Men’s Health is in Crisis. Movember. Accessed November 30, 2023. https://us.movember.com/about/cause
2. Lokeshwar SD, Patel P, Fantus RJ, et al. Decline in Serum Testosterone Levels Among Adolescent and Young Men in the USA. Eur Urol Focus.2021 Jul;7(4):886-889.doi: 10.1016/j.euf.2020.02.006.
3. Mulligan T, Frick MF, Zuraw QC, et al. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract.2006 Jul 1; 60(7): 762–769. doi: 10.1111/j.1742-1241.2006.00992.x
4. KYZATREX [prescribing information]. Raleigh, NC: Marius Pharmaceuticals.
5. Data on File. Raleigh, NC: Marius Pharmaceuticals, 2020.

News

Marius Pharmaceuticals Expands Access of KYZATREX™ (testosterone undecanoate) to Department of Veterans Affairs (VA), Pledging Support for Proper Hormonal Balance Among Military Personnel

RALEIGH, N.C., Sept. 19th, 2023 – Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, is proud to announce the expansion of access to its FDA-approved oral testosterone therapy, KYZATREX™, to the
Department of Veteran Affairs (VA). This initiative is a significant milestone in Marius Pharmaceutical’s ongoing mission to provide accessible and life-enhancing therapies to focused communities.

Military personnel face an array of physical and psychological health challenges, including but not limited to stress, insomnia, emotional distress, and physical injuries. Veterans often endure unresolved health implications, including mental health conditions, that are frequently linked to low testosterone. A lack of awareness about the impacts of military service on both hormone health and symptom stigma makes it difficult for veterans to confront low testosterone.

Studies have shown that the stress associated with intense military field training can result in up to a 47% decrease in testosterone levels. With increased education and awareness about this connection, veteran mental and physical health can be addressed. Marius Pharmaceuticals is committed to offering a safe and accessible oral solution with KYZATREX™. By providing a trusted therapy like KYZATREX™, Marius aims to not only enhance the long-term quality of life for these individuals but also contribute to the savings to the U.S. Healthcare system.

“At Marius Pharmaceuticals, we are proud to offer a treatment option to our veterans who have suffered from the physical and mental conditions associated with Low T, while bringing awareness of their plight to countless others who might not have realized the connection. Early
diagnosis and treatment can reduce or eliminate downstream expenses freeing up budget dollars to help more veterans obtain the help they deserve,” shared Rich Callaghan, SVP, Operations at Marius Pharmaceuticals.

As part of its comprehensive effort to raise awareness about testosterone deficiency or hypogonadism, Marius Pharmaceuticals has launched the ReThink Testosterone disease state awareness initiative and website. ReThink Testosterone is committed to educating individuals, including veterans and active-duty service members, about the impact of low testosterone on overall health and well-being. The initiative will continue to expand its content and resources to provide valuable information on this critical topic.

About KYZATREX™:
KYZATREX™ is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX™ was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX™ achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX™ reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥ 2 percent of KYZATREX™ patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX™ in males less than 18 years old have not been established.

Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX™ or visit www.kyzatrex.com.

About Marius Pharmaceuticals:
Marius Pharmaceuticals strives to better the lives of men and women by focusing on therapies designed for hypogonadism or Testosterone Deficiency. Their vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.

About ReThink Testosterone:
ReThink Testosterone is a disease state awareness campaign that aims to transform lives through education and support for individuals affected by low testosterone or Low T (male hypogonadism). Its mission is to enhance understanding of the symptoms, impact, and available treatment options for this condition, empowering men to make informed decisions about their health and well-being. For more information, please visit www.rethinktestosterone.com.

Important Safety Information for KYZATREX™ (testosterone undecanoate)

Use

KYZATREX™ (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX™ is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX™ is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX™ is not meant for use by women.

Important Safety Information for KYZATREX™

KYZATREX™ can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

·If your blood pressure increases while on KYZATREX™, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
·If your blood pressure cannot be controlled, KYZATREX™ may need to be stopped.
·Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX™.

Do not take KYZATREX™ if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX™ may harm your unborn baby); are allergic to KYZATREX™ or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX™ if you have low testosterone due to age).

Before you take KYZATREX™, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX™ with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicines and pain medicines.

KYZATREX™ may cause other serious side effects including:
·Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX™ if your red blood cell count increases.
·If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX™. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
·Increased risk of prostate cancer.
·Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
·Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
·In large doses, KYZATREX™ may lower your sperm count.
·Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
·Swelling of your ankles, feet, or body (edema), with or without heart failure.
·Enlarged or painful breasts.
·Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX™ is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX™. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040.

Keep KYZATREX™ and all medicines out of the reach of children.
See Full Prescribing Information and Medication Guide for KYZATREX™.

Media Contact:
Lilly Washburn
336-404-9622
lilly@mariuspharma.com

News

Marius Pharmaceuticals Partners with Smartway to Design and Manage the Global Early Access Program for KYZATREX™ (testosterone undecanoate)

RALEIGH, N.C., August 10, 2023 – Marius Pharmaceuticals (Marius) and Smartway Pharmaceuticals (Smartway) are pleased to announce their strategic partnership, aimed at addressing the pressing global issue of hypogonadism through the launch of a comprehensive Early Access Program for KYZATREX™ (testosterone undecanoate).

Hypogonadism, a prevalent medical condition affecting millions of men worldwide, is characterized by low testosterone levels, which can lead to a range of comorbidities, including obesity, type 2 diabetes, depression, and cardiovascular disease. Recognizing the critical need for innovative solutions to alleviate the burden of this condition, the collaboration between Marius and Smartway marks a significant milestone in expanding access to KYZATREX™, a groundbreaking therapeutic option already demonstrating promise in improving the lives of men across the United States.

Smartway Pharmaceuticals, a specialist in the provision of early access, compassionate use, and named patient supply of new therapeutics, is appointed the exclusive Early Access Provider for KYZATREX™ in all countries outside of the USA. Smartway has hubs across the globe including in the UK, EU, Middle East, USA, and India.

Josh Cocklin, Chief Executive of Smartway, expressed his enthusiasm for the collaboration, stating, “KYZATREX™ is already making a difference in the lives of men across the USA. With this agreement, we will extend access to KYZATREX™ to patients across the world. We believe that there will be significant interest in KYZATREX™ from healthcare specialists globally.”

This latest agreement extends the portfolio of Early Access Programs Smartway is managing and continues their journey as one of the most rapidly expanding EAP providers in the industry, being trusted by large and small biotech companies and manufacturers.

Shalin Shah, CEO of Marius Pharmaceuticals, emphasized the significance of the partnership, stating, “We have seen the difference KYZATREX™ has made to patients’ lives in the USA and are excited that this agreement will expand access. Marius is focused on the US market, so we needed a patient-centric partner with deep expertise. Smartway has the capability to provide access to KYZATREX™ on a global basis while meeting the strict regulatory standards. Smartway matches our desire to help patients and has the expertise combined with a global network to get KYZATREX™ to patients. We view this as a strategic long-term partnership.”

As the world grapples with the escalating burden of hypogonadism and its associated comorbidities, the collaboration between Marius Pharmaceuticals and Smartway Pharmaceuticals represents a united effort to bring KYZATREX™ to the forefront of the global battle against this pervasive medical condition. Through this innovative Early Access Program, the partners seek to empower healthcare professionals worldwide with a transformative therapeutic solution that can positively impact the lives of millions of men suffering from low testosterone and its related health challenges.

About Smartway Pharmaceuticals (www.smartwaypharma.com)

Smartway Pharmaceuticals designs, implements, and manages global Early / Expanded Access Programs, intended to empower access to medicines on a global level and help transform lives. We partner with pharma and biotechs who trust Smartway as a leader in the provision of Expanded Access, Early Access, Compassionate Use and Named Patient Programs across 98 countries.

Over the last 20 years, we’ve gained the experience it takes to strategically advise, design, initiate and manage global or regional programs with biotechs and pharma. As part of its specialist offering, Smartway provide end-to-end solutions to manage complex EAPs, whatever the size and scale, Smartway are committed to empowering patient access to the right therapy. https://www.smartwaypharma.co.uk/how-we-help/eap

About KYZATREX™
KYZATREX™ is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated
with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX™ was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX™ achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX™ reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥ 2 percent of KYZATREX™ patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX™ in males less than 18 years old have not been established. Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX™ or visit www.kyzatrex.com.
KYZATREX™ is only licensed in the USA.

About Marius Pharmaceuticals
Marius Pharmaceuticals is a patient-centric healthcare company focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company’s mission is to improve the functional lives of patients by reducing the downstream effects of Testosterone Deficiency, which include multiple comorbidities, such as type 2 diabetes, obesity, cardiovascular disease, and depression. For more information, please visit www.mariuspharma.com.

Smartway Pharmaceuticals
Robert Donnell, Executive Vice President- Medicines Access
+44 20 4551 5884 eap@smartwaypharma.com
Anna Vassova, Marketing Manager
marketing@smartwaypharma.com

Marius Pharmaceuticals
Lilly Washburn
+1 (336) 404-9622
lilly@mariuspharma.com

Use

KYZATREX™ (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX™ is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX™ is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX™ is not meant for use by women.

Important Safety Information for KYZATREX™

KYZATREX™ can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

· If your blood pressure increases while on KYZATREX™, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
· If your blood pressure cannot be controlled, KYZATREX™ may need to be stopped.
· Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX™.

Do not take KYZATREX™ if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX™ may harm your unborn baby); are allergic to KYZATREX™ or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX™ if you have low testosterone due to age).

Before you take KYZATREX™, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX™ with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX™ may cause other serious side effects including:
· Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX™ if your red blood cell count increases.
· If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX™. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
· Increased risk of prostate cancer.
· Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
· Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
· In large doses, KYZATREX™ may lower your sperm count.
· Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
· Swelling of your ankles, feet, or body (edema), with or without heart failure.
· Enlarged or painful breasts.
· Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX™ is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX™. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040.

Keep KYZATREX™ and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX™.

News

Marius Pharmaceuticals Announces Launch of ReThink Testosterone, Disease-State Awareness Initiative for Patients

RALEIGH, N.C. July 24, 2023 – Marius Pharmaceuticals, a patient-centric healthcare company specializing in therapies for hypogonadism or Testosterone Deficiency, is proud to announce the launch of their disease state awareness website, ReThink Testosterone. With the aim of changing the narrative surrounding testosterone and testosterone therapy, ReThink Testosterone seeks to empower men dealing with Low T to advocate for their health by providing valuable education and debunking long-standing myths.

Low testosterone, also known as male hypogonadism, affects millions of men worldwide, often impacting their overall health and well-being. However, misconceptions and stigma have created barriers to understanding and seeking appropriate treatment. ReThink Testosterone is a comprehensive online resource designed to address this gap, equipping men with knowledge to make informed decisions about their health.

“At Marius Pharmaceuticals, we believe in empowering individuals to take control of their health,” said Shalin Shah, CEO of Marius Pharmaceuticals. “Our goal with the launch of ReThink Testosterone is to provide a platform where men with low testosterone can better understand the symptoms, impacts, and treatment options available to them.”

ReThink Testosterone offers a wealth of information and resources, including informative videos, insightful podcasts, and relevant studies, all focused on testosterone and testosterone therapy. By debunking prevalent myths and misconceptions, the website aims to alleviate confusion and provide clarity on the benefits and potential risks associated with testosterone therapy. Additionally, visitors can access information about symptoms, diagnosis, and various treatment options.

The website goes beyond just discussing low testosterone itself. It aims to educate visitors about the relationship between Low T and various comorbidities, such as type 2 diabetes, obesity, cardiovascular disease, and more. By highlighting the potential links between low testosterone and these conditions, ReThink Testosterone provides a holistic view of hormonal health and its impact on overall well-being.

ReThink Testosterone caters to men who are experiencing low testosterone or those who have an interest in understanding testosterone and its implications. The website serves as a valuable resource to facilitate open conversations between patients and healthcare providers, promoting proactive engagement in managing hormonal health.

Dispelling common myths is a key focus of ReThink Testosterone. Misconceptions such as testosterone therapy causing serious adverse cardiovascular events, being solely a hormone for sexual and muscular purposes, or leading to aggression will be addressed through evidence-based information and expert insights. Other myths, including claims that testosterone therapy causes prostate cancer, will also be refuted, ensuring that visitors have accurate and reliable information at their fingertips.

By visiting ReThink Testosterone at www.rethinktestosterone.com or following on Instagram (@rethinktestosterone), individuals can embark on a journey of understanding and empowerment. The website will serve as a trusted resource, enabling men to recognize the symptoms of Low T, take proactive steps towards diagnosis and treatment, and ultimately improve their overall quality of life.

About Marius Pharmaceuticals:

Marius Pharmaceuticals is a patient-centric healthcare company focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company’s mission is to improve the functional lives of patients by reducing the downstream effects of Testosterone Deficiency, which include multiple comorbidities, such as type 2 diabetes and obesity. For more information, please visit www.mariuspharma.com.

About ReThink Testosterone:

ReThink Testosterone is a disease state awareness campaign that aims to transform lives through education and support for individuals affected by low testosterone or Low-T (male hypogonadism). Its mission is to enhance understanding of the symptoms, impact, and available treatment options for this condition, empowering men to make informed decisions about their health and well-being.

Media Contact:

Lilly Washburn

336-404-9622

lilly@mariuspharma.com

News

Marius Pharmaceuticals Supports AXYS 2023 Virtual Family Conference, Spotlighting KYZATREX™ for XY Chromosome Variations, such as Klinefelter’s Syndrome

RALEIGH, N.C., June 20, 2023 – Marius Pharmaceuticals, a patient-centric healthcare company specializing in therapies for hypogonadism or testosterone deficiency, announced today its sponsorship of the AXYS 2023 Virtual Family Conference. This conference serves as a significant platform for individuals and families affected by XY Chromosome Variations, including conditions such as Klinefelter’s Syndrome.

KYZATREX™ (testosterone undecanoate), an oral medication developed by Marius Pharmaceuticals, has emerged as a viable treatment option for those with Klinefelter’s Syndrome. As the XY Chromosome Variations community seeks oral alternatives for testosterone replacement therapy (TRT), Marius Pharmaceuticals recognizes the significance of KYZATREX™ in meeting this demand.

The AXYS Family Conference brings together individuals with these chromosome variations, their families, caregivers, and a diverse range of professionals including genetic counselors, geneticists, endocrinologists, and advocates. With nearly 1,000 attendees anticipated from the United States and around the world, the conference fosters an environment of education, support, and connection.

Klinefelter’s Syndrome, a genetic condition characterized by an additional X chromosome in males, presents various challenges such as low sperm count, small testicles, reduced sex drive, increased height, weakened bones, and diminished muscle mass. KYZATREX™, easily accessible and convenient, offers effective management of this condition. However, many patients struggle to access oral testosterone therapies due to insurance coverage limitations. Marius Pharmaceuticals is committed to addressing this issue and ensuring patients have access to the treatment they need with a cash-pay treatment.

“We are dedicated to providing individuals with XY Chromosome Variations, particularly those with Klinefelter’s Syndrome, with a therapy that is both effective and accessible,” stated Shalin Shah, CEO of Marius Pharmaceuticals. “Our sponsorship of the AXYS 2023 Virtual Family Conference underscores our commitment to improving the lives of these individuals and their families.”

Marius Pharmaceuticals remains at the forefront of research and development, striving to advance the field of testosterone replacement therapy and support patients in need. Through ongoing efforts and patient support programs, Marius Pharmaceuticals aims to address the challenges faced by individuals with XY Chromosome Variations and enhance their quality of life.

About KYZATREX™

KYZATREX™ is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX™ was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX™ achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX™ reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥ 2 percent of KYZATREX™ patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX™ in males less than 18 years old have not been established.

Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX™ or visit www.kyzatrex.com.

About Marius Pharmaceuticals

Marius Pharmaceuticals is a patient-centric healthcare company focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company’s mission is to improve the functional lives of patients by reducing the downstream effects of Testosterone Deficiency, which include multiple comorbidities, such as type 2 diabetes and obesity. For more information, please visit www.mariuspharma.com.

Important Safety Information for KYZATREX™ (testosterone undecanoate)

Use

KYZATREX™ (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX™ is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX™ is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX™ is not meant for use by women.

Important Safety Information for KYZATREX™

KYZATREX™ can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

· If your blood pressure increases while on KYZATREX™, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.

· If your blood pressure cannot be controlled, KYZATREX™ may need to be stopped.

· Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX™.

Do not take KYZATREX™ if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX™ may harm your unborn baby); are allergic to KYZATREX™ or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX™ if you have low testosterone due to age).

Before you take KYZATREX™, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX™ with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX™ may cause other serious side effects including:

· Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX™ if your red blood cell count increases.

· If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX™. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.

· Increased risk of prostate cancer.

· Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.

· Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.

· In large doses, KYZATREX™ may lower your sperm count.

· Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).

· Swelling of your ankles, feet, or body (edema), with or without heart failure.

· Enlarged or painful breasts.

· Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX™ is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX™. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040.

Keep KYZATREX™ and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX™.

Contact:

Lilly Washburn

336-404-9622 Lilly@mariuspharma.com

News

Marius Pharmaceuticals Announces Two Key Patents Related to KYZATREX™ in FDA Orange Book

RALEIGH, N.C., June 9, 2023 – Marius Pharmaceuticals, a patient-centric healthcare company focused on therapies designed for hypogonadism or testosterone deficiency, announced that its U.S. patents related to KYZATREX™ (testosterone undecanoate), No. 11590146B2 and No. 11617758B2, are now listed in the U.S. Food and Drug Administration (FDA) publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”

These patents represent significant milestones for Marius Pharmaceuticals as they underpin the broad coverage of KYZATREX’s™ advanced delivery system. This unique system has played a pivotal role in driving and generating robust safety and efficacy outcomes during the drug’s Phase 3 clinical trials.

The Orange Book lists patents for FDA-approved drugs that have been determined to be safe and effective for public use. Being included in this publication allows drug manufacturers to better monitor the introduction of potential generic drugs that may enter the U.S. market and potentially infringe on their patents.

“We are glad to announce the listing of these two pivotal patents related to KYZATREX™ in the FDA Orange Book,” said Shalin Shah, CEO of Marius Pharmaceuticals. “This recognition highlights the significant advancements we have made in developing a groundbreaking drug delivery system for Testosterone. These patents reinforce our commitment to providing patients with safe, effective, and innovative treatment options.”

About KYZATREX™

KYZATREX™ is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX™ was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX™ achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX™ reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥ 2 percent of KYZATREX™ patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX™ in males less than 18 years old have not been established.

Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX™ or visit www.kyzatrex.com.

About Marius Pharmaceuticals

Marius Pharmaceuticals is a patient-centric healthcare company focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company’s mission is to improve the functional lives of patients by reducing the downstream effects of Testosterone Deficiency, which include multiple comorbidities, such as type 2 diabetes and obesity. For more information, please visit www.mariuspharma.com.

Important Safety Information for KYZATREX™ (testosterone undecanoate)

Use

KYZATREX™ (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX™ is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX™ is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX™ is not meant for use by women.

Important Safety Information for KYZATREX™

KYZATREX™ can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

· If your blood pressure increases while on KYZATREX™, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.

· If your blood pressure cannot be controlled, KYZATREX™ may need to be stopped.

· Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX™.

Do not take KYZATREX™ if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX™ may harm your unborn baby); are allergic to KYZATREX™ or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX™ if you have low testosterone due to age).

Before you take KYZATREX™, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX™ with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX™ may cause other serious side effects including:

· Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX™ if your red blood cell count increases.

· If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX™. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.

· Increased risk of prostate cancer.

· Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.

· Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.

· In large doses, KYZATREX™ may lower your sperm count.

· Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).

· Swelling of your ankles, feet, or body (edema), with or without heart failure.

· Enlarged or painful breasts.

· Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX™ is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX™. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040.

Keep KYZATREX™ and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX™.

Contact:

Lilly Washburn

336-404-9622 Lilly@mariuspharma.com

News

Marius Pharmaceuticals Receives FDA Approval of KYZATREX™, an Oral Testosterone Replacement Therapy

August 2, 2022

RALEIGH, N.C. August 2, 2022 — Marius Pharmaceuticals, a patient-centric healthcare company, today announced the approval of KYZATREX™ (testosterone undecanoate) by the U.S. Food and Drug Administration (FDA). KYZATREX™ is an oral testosterone replacement therapy (“TRT”) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. The approval of KYZATREX™ provides an important option in treating hypogonadism or more commonly known as, Testosterone Deficiency, which affects approximately 40% of men older than 45 years of age and 30-50% of men with obesity or type 2 diabetes have hypogonadism1. KYZATREX™ has been approved in three dosage strengths, 100mg, 150mg, and 200mg.

“I would like to congratulate our scientific team on this major milestone, and now it is up to our commercial team to make KYZATREX™ a leading therapy and a go-to brand for millions of hypogonadal men in the U.S. Low Testosterone affects numerous metabolic factors as well as often overlooked, true quality of life, hence annual testosterone testing should be mandatory for men over age 40,” remarked Himanshu H. Shah, Chairman of Marius.

KYZATREX™ is a proprietary oral softgel capsule that is absorbed primarily via the lymphatic system, avoiding liver toxicity. The oral delivery method eliminates the risk of application site reactions common with intramuscular testosterone injections as well as potential transference to women or children that can occur with topical testosterone gels and creams. With daily dosing in the morning and evening (with food), KYZATREX™ more closely mimics the daily rhythm of natural testosterone production compared to long-acting therapies.

“With so many men suffering daily effects of Testosterone Deficiency and often abandoning or not electing to get treatment, we see FDA-approved KYZATREX™ as a newly viable oral option that has demonstrated safety and effectiveness. Further, Testosterone Deficiency is a big blind spot in medicine today and our research will continue to explore the importance of testosterone in both male and female health,” commented Shalin Shah, CEO of Marius.

KZAYTREX™ has the potential to become the new gold standard of care for treating patients with hypogonadism. There are at least six million symptomatic men suffering from hypogonadism in the U.S., and over 100 million men globally.

Please see additional Important Safety Information for KYZATREX™ below.

About Testosterone and Hypogonadism

Hypogonadism, often referred to as Testosterone Deficiency, is a condition that occurs when the body does not produce adequate levels of testosterone. Primary hypogonadism (testicular failure due to certain conditions) and hypogonadotropic hypogonadism both result in low serum testosterone concentrations. In addition to testosterone’s widely accepted role in sexual and reproductive function, it also has important roles in numerous other metabolic and inflammatory process and is one of the most common causes of secondary osteoporosis in men. Patients with hypogonadism may experience fatigue, low energy, decreased muscle mass, weight gain, low libido, poor cognition, difficulty sleeping, and other mood disorders, such as depression and anxiety. Because low levels of testosterone can also increase the risk of developing type 2 diabetes and obesity, hypogonadism is a common comorbidity in a broader set of conditions, including type 2 diabetes and Non-Alcoholic Steatohepatitis (NASH).

About KYZATREX™

KYZATREX™ is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX™ was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX™ achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX™ reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥ 2 percent of KYZATREX™ patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX™ in males less than 18 years old have not been established.

Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX™.

About Marius Pharmaceuticals

Marius Pharmaceuticals is a patient-centric healthcare company focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company’s mission is to improve the functional lives of patients by reducing the downstream effects of Testosterone Deficiency, which include multiple comorbidities, such as type 2 diabetes and obesity. For more information, please visit www.mariuspharma.com

Important Safety Information for KYZATREX™ (testosterone undecanoate)

Use

KYZATREX™ (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX™ is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX™ is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX™ is not meant for use by women.

Important Safety Information for KYZATREX™

KYZATREX™ can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

If your blood pressure increases while on KYZATREX™, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
If your blood pressure cannot be controlled, KYZATREX™ may need to be stopped.
Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX™.

Do not take KYZATREX™ if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX™ may harm your unborn baby); are allergic to KYZATREX™ or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX™ if you have low testosterone due to age).

Before you take KYZATREX™, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX™ with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX™ may cause other serious side effects including:

Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX™ if your red blood cell count increases.
If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX™. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
Increased risk of prostate cancer.
Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
In large doses, KYZATREX™ may lower your sperm count.
Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
Swelling of your ankles, feet, or body (edema), with or without heart failure.
Enlarged or painful breasts.
Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX™ is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX™. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-800-949-5040.

Keep KYZATREX™ and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX™.

Media Contact:Lilly Washburn

lilly@mariuspharma.com

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Important Safety Information for KYZATREX™

KYZATREX™ may cause other serious side effects including:

Important Safety Information for KYZATREX™ (testosterone undecanoate)