Less than four years after its formation, a Durham pharmaceutical company has secured its first drug approval from the U.S. Food and Drug Administration.
Mycovia Pharmaceuticals announced Thursday that regulators approved Vivjoa, an oral antifungal drug intended to treat recurrent vulvovaginal candidiasis (RVVC), more commonly known as chronic yeast infection. This is the first FDA-approved medication to treat this condition.
"It's an exciting inflection point for us," said Mycovia CEO Patrick Jordan. "We've been thinking for the last four years about developing molecules, and now that we have a molecule that's been approved, the attention shifts to commercialization."
Mycovia is planning to launch the drug later this quarter. Developing a strategy to do so has been the company's focus since submitting a new drug application for Vivjoa to the FDA last June. Jordan said the lean company of 30 employees will rely on internal resources to manage manufacturing and commercial operations, while outsourcing much of those operations to larger contract service providers.
As a smaller company, this approach felt like it struck the right balance, Jordan said. It also speaks to his own experience in the outsourcing business, including his 20 years spent at Iqvia (NYSE: IQV).
"It allows us to remain nimble and adjust to changes in the market," Jordan said.
Mycovia will run this launch in the U.S., while two different companies, one based in China and the other in Europe, focus on moving the drug through the regulatory process and into manufacturing and commercialization elsewhere in the world. Under the different licensing agreements, Budapest-based Gedeon Richter will be responsible for Europe, Latin America, Australia and Russia; while Jiangsu Hengrui Medicine Co. will focus on China.
Jordan said the company is proud of how those relationships are working as its partner in Europe will soon file an application with regulators there and a phase 3 study is underway in China.
With the launch of Vivjoa, Mycovia will for the first time generate revenue. Raleigh-based NovaQuest Capital Management, where Jordan is a managing partner, has financed the company since it launched in 2018. The company was formed after NovaQuest's acquisition of another Triangle firm called Viamet Pharmaceuticals.
As a private company, Jordan declined to disclose Mycovia's financial projections for the drug. But without previously having an FDA-approved market, the recurrent market for vulvovaginal candidiasis is largely untapped. Jordan said data shows up to 9 percent of adult women who have experienced at least one yeast infection could develop the chronic condition.
"This disease is an important one that needs addressing," Jordan said. "We have a goal to make the drug available and affordable for women who are appropriate RVVC patients."
Mycovia's Vivjoa is novel drug No. 11 to receive FDA approval so far this year. This doesn't include blood products, plasma derivates or cell and gene therapy products, which are regulated by a different center within the FDA. In 2021, the FDA approved 50 novel drugs through its Center for Drug Evaluation and Research.
