Thursday, October 17, 2019
Mycovia Pharmaceuticals, Inc. today announced it has entered into an exclusive license and development and technology transfer agreement with Gedeon Richter Plc., based in Budapest, Hungary, to commercialize and manufacture VT-1161 in Europe, Latin America, Australia, Russia and other CIS countries. VT-1161, an oral antifungal product candidate, is currently in Phase 3 clinical trials for the treatment of Recurrent Vulvovaginal Candidiasis (RVVC), a debilitating, chronic infectious condition that affects nearly 138 million women worldwide each year.
“We are excited to partner with Gedeon Richter, 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, CEO of Mycovia and Partner at NovaQuest Capital Management, which formed Mycovia in 2018 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. 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 currently 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.
“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 Plc. “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.”
With this partnership, Mycovia is eligible to receive milestone payments related to clinical, regulatory and commercial success of the product.
This agreement builds on Mycovia’s previously announced deal with Jiangsu Hengrui Medicine Co., Ltd., to develop and commercialize VT-1161 in China, including mainland China, Hong Kong, Macau and Taiwan.