DURHAM, N.C.--(BUSINESS WIRE)--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.
About Mycovia Pharmaceuticals
Mycovia Pharmaceuticals has a passion for developing breakthrough therapies in areas of unmet medical need, with an initial focus in women’s health. Our lead product candidate, VT-1161, is a novel, oral therapy for RVVC that is designed to have greater selectivity, fewer side effects and improved efficacy than current treatment options. VT-1161 received FDA Qualified Infectious Disease Product and Fast-Track designations to support its potential as the first FDA-approved treatment for RVVC. Mycovia also recognizes that there is tremendous potential for its oral fungal inhibitors to treat a range of multi-drug resistant fungal pathogens. For more information, please visit www.mycovia.com.
About Gedeon Richter
Gedeon Richter Plc. (www.richter.hu), headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe, in China and in Latin America. Having reached a market capitalisation of EUR 3.2 billion (USD 3.6 billion) by the end of 2018, Richter's consolidated sales were approximately EUR 1.4 billion (USD 1.6 billion) during the same year. The product portfolio of Richter covers many important therapeutic areas, including Women's Healthcare, Central Nervous System and Cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter's original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the Women's Healthcare field worldwide. Richter is also active in biosimilar product development.
About Recurrent Vulvovaginal Candidiasis
Recurrent vulvovaginal candidiasis is a debilitating, chronic infectious condition that affects millions of women. Primary symptoms include vaginal itching, burning, irritation and inflammation. Some women may experience abnormal vaginal discharge and painful sexual intercourse or urination, causing variable but often severe discomfort and pain. RVVC impacts quality of life, to a degree comparable to asthma and worse than diseases such as headache and migraine. In Europe, the standard of care treatment for RVVC has many drawbacks including limited effectiveness, safety concerns with chronic dosing, and inadequate ability to provide long-term protection.
About NovaQuest Capital Management
NovaQuest Capital Management is a leading investor in life sciences and healthcare through its Product Finance and Private Equity strategies. NovaQuest was formed in 2000 with the vision of building an investment platform to provide strategic capital to life sciences and healthcare companies. Today, NovaQuest Capital Management manages over $2.5 billion through its Product Finance and Private Equity strategies. The investment team consists of highly seasoned operational and investment professionals with significant investment experience and deep life science and healthcare expertise. Furthermore, NovaQuest benefits from an extensive network of industry experts and relationships that assist in identifying, analyzing and growing NovaQuest portfolio companies and investments. For more information, please visit www.novaquest.com.