aaron • December 27, 2019 • Comments Off on Mycovia Pharmaceuticals Announces Partnership with Gedeon Richter to Commercialize and Manufacture VT-1161 for Recurrent Vulvovaginal Cand
DURHAM, N.C.–( BUSINESS WIRE )–Mycovia Pharmaceuticals, Inc. today announced this has entered into a special permit and development and technology transfer contract with Gedeon Richter Plc., situated in Budapest, Hungary, to commercialize and produce VT-1161 in European countries, Latin America, Australia, Russia as well as other CIS countries. VT-1161, a dental product that is antifungal, happens to be in stage 3 medical studies for the remedy for Recurrent Vulvovaginal Candidiasis (RVVC), a debilitating, chronic infectious condition that impacts nearly 138 million females global every year.
“We are excited to partner with Gedeon Richter, a business with strong market leadership in women’s health, to build up and commercialize VT-1161, our possible 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 worldwide areas. “VT-1161 is well placed to deal with the needs of the an incredible number of ladies who have problems with disquiet, discomfort and emotional stress due to RVVC and generally are looking for a brand new therapy choice. We enjoy formalizing our commercial strategy and launch plans once we quickly advance VT-1161 through the hospital and prepare our submission that is regulatory.
VT-1161 was created to be very selective, with fewer side-effects and improved efficacy over present treatment plans. Mycovia happens to be conducting phase that is global trials of VT-1161 in women with RVVC to aid marketing applications when you look at the U.S., europe and Japan. Stage 2b studies have shown VT-1161 to own strong safety and effectiveness pages in RVVC clients, with as little as 0 % recurrence prices through 48 days.
“We are dedicated to expanding our core Women’s Healthcare profile, and we’re pleased to partner with Mycovia, with whom we share a mission of bringing therapies that are important females all over the world who possess conditions with severe unmet needs,” said Erik Bogsch, Executive Chairman of Gedeon Richter Plc. This contract will allow us to commercialize VT-1161 in Europe and extra key markets.“As there has been no brand new revolutionary treatments for RVVC established in European countries in over 2 decades”
This contract develops on Mycovia’s formerly announced cope with Jiangsu Hengrui Medicine Co., Ltd., to produce and commercialize VT-1161 in Asia, including mainland China, Hong Kong, Macau and Taiwan.
About Mycovia Pharmaceuticals Mycovia Pharmaceuticals has a desire for developing breakthrough therapies in aspects of unmet need that is medical with a preliminary focus in women’s wellness. Our lead item candidate, VT-1161, is really a novel, dental treatment for RVVC that is built to have greater selectivity, less negative effects and enhanced effectiveness than present treatments. VT-1161 received FDA Qualified Infectious Disease Product and Fast-Track designations to guide its possible because the very very very first treatment that is FDA-approved RVVC. Mycovia additionally understands that there is certainly tremendous possibility of its dental fungal inhibitors to take care of a selection of asian wife multi-drug resistant fungal pathogens. To learn more, please check out www.mycovia.com.
About Gedeon Richter Gedeon Richter Plc. ( www.richter.hu ), headquartered in Budapest/Hungary, is an important pharmaceutical business in Central Eastern European countries, having an expanding direct existence in Western Europe, in China as well as in Latin America. Having reached an industry capitalisation of EUR 3.2 billion (USD 3.6 billion) because of the conclusion of 2018, Richter’s consolidated product sales had been approximately EUR 1.4 billion (USD 1.6 billion) through the exact same 12 months. The item profile of Richter covers numerous essential areas that are therapeutic including ladies’ Healthcare, nervous system and Cardiovascular areas. Obtaining the biggest R&D unit in Central Eastern European countries, Richter’s initial research task centers around CNS problems. Having its commonly acknowledged chemistry that is steroid, Richter is a substantial player when you look at the Women’s Healthcare industry globally. Richter can be active in biosimilar item development.
About Recurrent Vulvovaginal Candidiasis Recurrent vulvovaginal candidiasis is a debilitating, chronic infectious condition that affects an incredible number of ladies. Primary observable symptoms include vaginal itching, burning, swelling and irrititation. Some females may experience unusual vaginal release and painful sexual activity or urination, causing adjustable but frequently severe vexation and discomfort. RVVC impacts well being, to a diploma similar to asthma and worse than conditions such as for example migraine and headache. In Europe, the typical of care treatment plan for RVVC has its own downsides including restricted effectiveness, security issues with chronic dosing, and insufficient power to provide long-lasting protection.