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.
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 .