Marius Pharmaceuticals Receives PDUFA Date for KYZATREX® NDA for Treatment of Hypogonadism

News

Base Healthcare Launches Innovative Platform for Men with Testosterone Deficiency

Oct. 18, 2022

RALEIGH, N.C., Oct. 18, 2022 (GLOBE NEWSWIRE) — Base Healthcare today announced the official launch of its subscription-based men’s virtual health platform, which focuses on foundational health and hormone optimization using oral testosterone therapy. The digital-forward platform will offer a convenient way for men to access Adequate Testosterone Therapy (ATT)™, certified-clinicians, and patient-centered health coaching.

Individuals can now visit https://basehealthcare.com/ where they can sign up to get a comprehensive metabolic blood panel, be diagnosed by a certified-clinician and prescribed an FDA-approved oral testosterone treatment that can be delivered directly to them. Base Healthcare is initially focused on the treatment of hypogonadism or low testosterone and will offer additional services and supplements for men in early 2023.

Base Healthcare chose the focus of low testosterone because it is one of the biggest blind spots in medicine today. There are over 20 million men in the U.S. suffering from hypogonadism or low testosterone today and almost 90% are unaware of it due to a lack of testing. Base believes every man over the age of 40 should have their testosterone levels routinely or annually checked. In addition to symptomatic men suffering from day-to-day quality of life loss, the downstream impact of low testosterone is significant and often co-related with obesity, Type 2 diabetes, cardiovascular disease and neurocognitive issues.

“We are excited to be launching this platform in a post-pandemic world when it’s imperative to be looking at foundational and preventive health measures, and adequate testosterone is just that. We are able to combine hormone expertise with a leading digital platform to offer men not just convenience, but expert guidance on their journey to better living,” said Amit Patel, Medical Director at Base Healthcare.

Launching alongside the platform is the Base Healthcare App, which includes many industry firsts. Patients will be able to utilize their smartphone to track important vitals, such as blood pressure, heart rate variability and stress indexes. Additionally, the app has integrated body composition analysis which is accurate to within 1% of a more traditional DEXA scan. “Building this platform from the ground up has allowed Base to incorporate technologies that will ultimately benefit members and we see substantially better patient adherence to treatment with this technological leadership,” said Abhi Muthiyan, Chief Technology Officer at Base Healthcare.

About Base Healthcare

Base Healthcare is a men’s virtual health platform focusing on foundational health and hormone optimization using testosterone therapy and patient-centered health coaching. Base utilizes an FDA-approved oral testosterone therapy and comprehensive blood work to target ideal optimal ranges for an individual. Its patient-centered health coaching program will focus on the core tenants of stress, nutrition, exercise, and sleep to drive important physiological processes that can serve as a base for better functional living.

About Testosterone and Hypogonadism

Hypogonadism, often referred to as low testosterone, 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. 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).

News

MARIUS PHARMACEUTICALS COMPLETES EFFICACY PHASE 3 STUDY

September 26, 2018

Marius Pharmaceuticals, a specialty pharmaceutical company, today announced positive preliminary data for their Phase 3 clinical trial evaluating SOV-2012-F1 in men suffering from hypogonadism. SOV-2012-F1 is Marius’ proprietary oral testosterone replacement therapy (TRT) uniquely utilizing phytosterols to enhance absorption through the lymphatic system. The predictable pharmacokinetics of Marius’ formulation should provide the framework for improved therapeutic effect in clinical practice, better patient compliance, and a reduction in adverse events associated with poor therapeutic control. Together, these advantages should result in true symptom relief for the millions suffering from this chronic condition globally.

“We are extremely pleased with the results of the trial thus far,” said Om Dhingra, Chief Executive Officer for Marius Pharmaceuticals. “This positive preliminary data supports our belief that, if approved, SOV-2012-F1 may offer a safe, effective, and convenient oral treatment for men suffering from hypogonadism.”

Affecting an estimated 22 million men (7% of the population) of all ages in the US alone, with corresponding higher global impact, hypogonadism is characterized by inadequate testosterone production due to issues with the testes or pituitary gland. Although widely recognized as important for sexual health, testosterone also has roles in neurological, musculoskeletal, cardiovascular, and pulmonary health. Patients afflicted with this under-researched endocrine condition experience symptoms such as fatigue and low libido, with an increased risk for type 2 diabetes, anemia, and decreased bone density. Men with low testosterone often suffer from the co-morbidities of obesity, diabetes, osteoporosis, or asthma.

Current treatment paradigms for hypogonadism focus on restoring testosterone levels using TRT, primarily administered either by injection or topical application. In 2018, an estimated 1.8 million men are on active TRT treatment. However, current treatments are burdensome, provide inconsistent daily relief, and in the case of topical (transdermal) products, have a black box warning due to the risk of transfer to partners and/or children. TRT intramuscular options currently on the market often result in prolonged peaks and troughs of testosterone levels. This pattern produces emotional highs and depressive lows for many patients. As a result, many eligible patients do not start treatment. Of those who do begin treatment, one third of patients discontinue within 12 months, primarily due to a lack of symptom improvement

Marius Pharmaceuticals’ novel and proprietary SOV-2012-F1 oral formulation of testosterone undecanoate seeks to address these concerns. Its innovative formulation enhances absorption and provides convenient oral dosing, which in turn should increase compliance, reduce adverse events, and provide consistent and predictable symptom relief, as supported by preliminary Quality of Life data. SOV-2012-F1 provides higher levels of free testosterone and is the only product under development containing phytosterol esters for improved absorption and tolerability. In addition to providing stable testosterone levels, its convenient oral administration removes the burden of repeated injections or topical applications. Based on the 90-day efficacy set of patient-reported outcomes, SOV-2012-F1 performed better than the leading topical gel in most key male quality of life measures, with patients seeing a greater improvement in emotional well-being, energy levels, sexual desire, erectile function, and prostate symptom scores.

“For the first time, oral TRT products are coming to the market, representing a paradigm shift that is greatly needed for men suffering from hypogonadism” said Shalin Y. Shah, Chief Financial Officer for Marius Pharmaceuticals. “We believe that the novel characteristics of SOV-2012-F1 will make it an ideal solution to this largely unmet medical need.”

News

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

May 21, 2020

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 SUBMITS NEW DRUG APPLICATION TO U.S. FDA FOR NEXT-GENERATION ORAL TESTOSTERONE REPLACEMENT THERAPY IN MALE PATIENTS WITH HYPOGONADISM

January 5, 2021

KYZATREX® NDA includes data demonstrating less than 2 mm Hg mean SBP increase as measured by Ambulatory Blood Pressure Monitoring (ABPM) in clinical study participants receiving the investigational drug

Raleigh, N.C., Jan. 5, 2021 — Marius Pharmaceuticals, a specialty pharmaceutical company focusing on treating conditions that are primarily associated with testosterone deficiency, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of KYZATREX®, its novel oral testosterone undecanoate soft gelatin capsule for the treatment of primary and secondary hypogonadism in adult men.

KYZATREX® has generated strong results in both safety and efficacy studies for KYZATREX® for treatment of primary and secondary hypogonadism in men. Due to the robust results, especially regarding safety, Marius has requested a Priority Review that, if granted, would result in an anticipated six-month review period.

“Submission of our first NDA is an important milestone, which is the culmination of over a decade of meticulous research and dedication and is just the beginning for Marius, as our pipeline will continue to advance research and development in this important therapeutic area that has a multitude of effects on our health system,” said Himanshu H. Shah, Founder and Executive Chairman of Marius.

The NDA submission is based on efficacy and safety data from its pivotal study (NCT04467697) in which KYZATREX® generated the most comprehensive ABPM data in its class. KYZATREX® was well tolerated by participants, with greater than 96% of those subjects completing 90 days of treatment achieving average testosterone levels in the normal range in the pivotal Phase 3 study. The most common treatment-related treatment-emergent adverse event (TEAE) in the pooled Phase 3 studies was hypertension, while there were no serious TEAEs across the Phase 3 trials deemed related to the study drug.

“We are extremely proud to have generated compelling efficacy and safety data in our Phase 3 trials,” commented Dr. Om Dhingra, Co-Founder and CEO of Marius. “We look forward to continuing to work collaboratively with the FDA on the review of our application, and if approved, KYZATREX® has the potential to become the standard of care (SOC) for the treatment of primary and secondary hypogonadism globally.”

Marius also intends to file a marketing authorization application (MAA) with the European Medicines Agency in the first half of 2022. For more information about Marius Pharmaceuticals and KYZATREX®, visit mariuspharma.com.

About Testosterone & 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 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 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 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 PHARMACEUTICALS RECEIVES PDUFA DATE FOR KYZATREX® NDA FOR TREATMENT OF HYPOGONADISM

March 11, 2021

RALEIGH, N.C., March 11, 2021 – Marius Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 31, 2021 for the review of the KYZATREX® New Drug Application (NDA) for primary and secondary male hypogonadism. KYZATREX®, an oral testosterone undecanoate softgel, had one of the most comprehensive Phase 3 trials in the testosterone space and if approved, has the potential to be the only first-action approval oral testosterone product on the market. The company plans to launch immediately following product approval.

Hypogonadism, commonly referred to as testosterone deficiency, occurs when the body does not produce sufficient testosterone levels on its own. While testosterone’s role in sexual and reproductive function is widely known, it is also vital to 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.

Evidence supports the need for research initiatives to examine hormonal imbalance and the benefits of testosterone therapy in reducing risk factors related to cardiometabolic diseases. Marius also supports broader testosterone testing protocols for those experiencing fatigue, decreased libido, depression, obesity, and Type 2 diabetes. To profess these initiatives, Marius is evaluating expansion of its research program to further explore the positive role of adequate levels of testosterone in the body.

About Healthcare Spend

The resulting medical costs associated with men with untreated hypogonadism and related comorbidities are approximately $25 billion in the U.S. alone. Hypogonadism is also the most common cause of secondary osteoporosis in men and related to a broader set of conditions ranging from Type 2 diabetes to non-alcoholic steatohepatitis, a type of fatty-liver disease.

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 nine 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 acceptedKYZATREX® as the trade name for this investigational drug. The safety and efficacy have not been fully evaluated by any regulatory authority.

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

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™

June 11, 2021

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 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

Cookie Policy

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Terms of Service

Terms

By accessing the website at https://www.mariuspharma.com/, you are agreeing to be bound by these terms of service, all applicable laws and regulations, and agree that you are responsible for compliance with any applicable local laws. If you do not agree with any of these terms, you are prohibited from using or accessing this site. The materials contained in this website are protected by applicable copyright and trademark law.

Use License

Permission is granted to temporarily download one copy of the materials (information or software) on Marius Pharmaceuticals’ website for personal, non-commercial transitory viewing only. This is the grant of a license, not a transfer of title, and under this license you may not:
1. modify or copy the materials;
2. use the materials for any commercial purpose, or for any public display (commercial or non-commercial);
3. attempt to decompile or reverse engineer any software contained on Marius Pharmaceuticals’ website;
4. remove any copyright or other proprietary notations from the materials; or
5. transfer the materials to another person or “mirror” the materials on any other server.
This license shall automatically terminate if you violate any of these restrictions and may be terminated by Marius Pharmaceuticals at any time. Upon terminating your viewing of these materials or upon the termination of this license, you must destroy any downloaded materials in your possession whether in electronic or printed format.

Disclaimer

The materials on Marius Pharmaceuticals’ website are provided on an ‘as is’ basis. Marius Pharmaceuticals makes no warranties, expressed or implied, and hereby disclaims and negates all other warranties including, without limitation, implied warranties or conditions of merchantability, fitness for a particular purpose, or non-infringement of intellectual property or other violation of rights.
Further, Marius Pharmaceuticals does not warrant or make any representations concerning the accuracy, likely results, or reliability of the use of the materials on its website or otherwise relating to such materials or on any sites linked to this site.

Limitations

In no event shall Marius Pharmaceuticals or its suppliers be liable for any damages (including, without limitation, damages for loss of data or profit, or due to business interruption) arising out of the use or inability to use the materials on Marius Pharmaceuticals’ website, even if Marius Pharmaceuticals or a Marius Pharmaceuticals authorized representative has been notified orally or in writing of the possibility of such damage. Because some jurisdictions do not allow limitations on implied warranties, or limitations of liability for consequential or incidental damages, these limitations may not apply to you.

Accuracy of materials

The materials appearing on Marius Pharmaceuticals’ website could include technical, typographical, or photographic errors. Marius Pharmaceuticals does not warrant that any of the materials on its website are accurate, complete or current. Marius Pharmaceuticals may make changes to the materials contained on its website at any time without notice. However Marius Pharmaceuticals does not make any commitment to update the materials.

Links

Marius Pharmaceuticals has not reviewed all of the sites linked to its website and is not responsible for the contents of any such linked site. The inclusion of any link does not imply endorsement by Marius Pharmaceuticals of the site. Use of any such linked website is at the user’s own risk.

Modifications

Marius Pharmaceuticals may revise these terms of service for its website at any time without notice. By using this website you are agreeing to be bound by the then current version of these terms of service.

Governing Law

These terms and conditions are governed by and construed in accordance with the laws of North Carolina and you irrevocably submit to the exclusive jurisdiction of the courts in that State or location.

Privacy Policy

Your privacy is important to us. It is Marius Pharmaceuticals’ policy to respect your privacy regarding any information we may collect from you across our website, https://www.mariuspharma.com/, and other sites we own and operate.

We only ask for personal information when we truly need it to provide a service to you. We collect it by fair and lawful means, with your knowledge and consent. We also let you know why we’re collecting it and how it will be used.

We only retain collected information for as long as necessary to provide you with your requested service. What data we store, we’ll protect within commercially acceptable means to prevent loss and theft, as well as unauthorized access, disclosure, copying, use or modification.

We don’t share any personally identifying information publicly or with third-parties, except when required to by law.

Our website may link to external sites that are not operated by us. Please be aware that we have no control over the content and practices of these sites, and cannot accept responsibility or liability for their respective privacy policies.

You are free to refuse our request for your personal information, with the understanding that we may be unable to provide you with some of your desired services.

Your continued use of our website will be regarded as acceptance of our practices around privacy and personal information. If you have any questions about how we handle user data and personal information, feel free to contact us.

This policy is effective as of 19 May 2020.

Terms of Service

Terms

By accessing the website at https://www.mariuspharma.com/, you are agreeing to be bound by these terms of service, all applicable laws and regulations, and agree that you are responsible for compliance with any applicable local laws. If you do not agree with any of these terms, you are prohibited from using or accessing this site. The materials contained in this website are protected by applicable copyright and trademark law.

Use License

Permission is granted to temporarily download one copy of the materials (information or software) on Marius Pharmaceuticals’ website for personal, non-commercial transitory viewing only. This is the grant of a license, not a transfer of title, and under this license you may not:
modify or copy the materials;

Marius Pharmaceuticals Receives PDUFA Date for KYZATREX® NDA for Treatment of Hypogonadism

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