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.
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.
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).
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.”
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).
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.
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
Shalin Shah
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.
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).
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.
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 .
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.
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.
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 .
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.
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.
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.
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.”
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.
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).
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
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