Health is our mission

Richter and Mycovia signed a series of agreements for the commercialization and manufacture of a novel oral antifungal to treat RVVC

10/16/2019

Gedeon Richter Plc. (“Richter”) and Mycovia Pharmaceuticals, Inc. (“Mycovia”) today announced that they have entered into an exclusive license and development and technology transfer agreement to commercialize and manufacture VT-1161, currently in Phase III clinical trials for the treatment of Recurrent Vulvovaginal Candidiasis (RVVC). VT-1161 is designed to be highly selective and have improved efficacy, and VT-1161 may avoid side effects that limit the use of current antifungals in the treatment of RVVC. The geographic scope of the license agreement covers Europe, Russia, the other CIS countries, Latin America and Australia.

​Under the terms of the agreement Richter shall make milestone payments related to the clinical development process. These payments shall extend over the next two years and will total USD 20 million. Additional development and sales milestone payments shall be due depending on the progress of the regulatory process and commercial success of the product.  In addition, the two companies signed a royalty purchase agreement according to which Richter also acquires a certain portion of the net turnover of US sales of the product for the purchase price of USD 25 million.

"Expanding our core Women's Healthcare portfolio has been in the focus of Richter's strategy and we are confident that this recent project will successfully widen the scope of our existing portfolio," stated Gábor Orbán, Chief Executive Officer of Richter.

"We are excited to partner with Gedeon Richter, a global leader in women's health, to develop and commercialize VT-1161 for the treatment of RVVC," said Patrick Jordan, CEO of Mycovia Pharmaceuticals and Partner at NovaQuest Capital Management. "RVVC affects 138 million women around the world, causing not only discomfort and pain but also emotional distress, all of which can have a profound impact on quality of life. With Gedeon Richter's strong market leadership in women's health, VT-1161 is well positioned to address the needs of millions of women suffering from RVVC."

 

About VT-1161

VT-1161 is an orally available inhibitor of fungal CYP51 infection being developed by Mycovia for the treatment of Recurrent Vulvovaginal Candidiasis (RVVC) and onychomycosis. VT-1161 is designed to have greater selectivity, fewer side effects and improved efficacy.

 

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 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. Their 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 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 capitalization 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.

 

For more information:

Richter:

Investors:

Katalin Ördög:                                    +36 1 431 5680

Media:

Zsuzsa Beke:                         +36 1 431 4888

 

Mycovia:

Tiffany Ahlers

Phone: 919-467-8539

Email: tahlers@mycovia.com

Media

FleishmanHillard

Anuj Baveja

Phone: 919-334-3782

Mobile: 551-587-2233

Email: anuj.baveja@fleishman.com