Mycovia Deal with European Firm Advances Antifungal Drug

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Mycovia Pharmaceuticals of Durham is partnering with a major Hungarian pharmaceutical company to commercialize and manufacture one of Mycovia’s drug candidates in Europe, Latin America, Australia, Russia and other former Soviet countries.

Mycovia signed an exclusive license and development and technology transfer agreement with Gedeon Richter of Budapest for VT-1161, an oral antifungal product candidate now in Phase 3 clinical trials for the treatment of recurrent vulvovaginal candidiasis (RVVC). 

RVVC, better known as chronic yeast infection, affects nearly 138 million women worldwide each year. 

“We are excited to partner with Gedeon Richter Plc., a company with strong market leadership in women’s health, to develop and commercialize VT-1161, our potential first FDA-approved treatment for RVVC,” said Patrick Jordan, chief executive officer of Mycovia and partner at NovaQuest Capital Management, a Raleigh-based investment firm that formed Mycovia to advance VT-1161 in global markets. 

“VT-1161 is well positioned to address the needs of the millions of women who suffer from discomfort, pain and emotional distress caused by RVVC and are seeking a new treatment option,” Jordan said. “We look forward to formalizing our commercial strategy and launch plans as we rapidly advance VT-1161 through the clinic and prepare our regulatory submission.”

VT-1161 is designed to be highly selective, with fewer side effects and improved efficacy over current treatment options. Mycovia is conducting global Phase 3 trials of VT-1161 in women with RVVC to support marketing applications in the U.S., the European Union and Japan. Phase 2b studies have shown VT-1161 to have strong safety and efficacy profiles in RVVC patients, with as low as 0 percent recurrence rates through 48 weeks, according to the company.

“We are committed to expanding our core women’s healthcare portfolio, and we’re delighted to partner with Mycovia, with whom we share a mission of bringing important therapies to women around the world who have diseases with serious unmet needs,” said Erik Bogsch, executive chairman of Gedeon Richter. “As there have been no new innovative therapies for RVVC launched in Europe in over two decades, this agreement will enable us to commercialize VT-1161 in Europe and additional key markets.”

Deal brings access to milestone payments

With the partnership, Mycovia is eligible to receive milestone payments related to the product’s clinical, regulatory and commercial success.

The agreement builds on Mycovia’s previously announced deal with Jiangsu Hengrui Medicine Co. to develop and commercialize VT-1161 in China, including mainland China, Hong Kong, Macau and Taiwan.

In the United States, VT-1161 received FDA Qualified Infectious Disease Product and Fast-Track designations to support its potential as the first FDA-approved treatment for RVVC. 

The agent has also been studied for the treatment of onychomycosis, a fungal infection of the nail that affects about 35 million people in the United States.

Mycovia is also developing other oral fungal inhibitors to treat a range of multi-drug resistant fungal pathogens including VT-1598, which has shown activity against difficult-to-treat infections including Candida auris, Aspergillosis species, and pathogens responsible for valley fever and cryptococcal meningitis.

Mycovia was founded in 2018 following the acquisition of Viamet Pharmaceuticals by NovaQuest Capital Management. 

Gedeon Richter is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe, China and Latin America. The company had a market capitalization of $3.6 billion by the end of 2018 and sales of $1.6 billion the same year. 

Richter’s product portfolio includes women's healthcare, central nervous system and cardiovascular areas.

Barry Beater, NCBiotech Writer
Tue, 10/22/2019 - 14:24