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.
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