Lupin buys US-based vaginosis drug maker for $150 mln

Pharma major Lupin said that its US subsidiary, Lupin, Inc has acquired Symbiomix Therapeutics, LLC for a cash consideration of USD 150 million including a USD 50 million upfront and other time‐based payments.

In addition, there are sales based contingent payments.

Lupin had entered into an option to acquire the company earlier this year.

Symbiomix is a privately held company focused on bringing innovative therapies to market for gynecologic infections that can have serious health consequences.

The acquisition is funded from internal funds, Lupin said, and the deal was closed today.

“The acquisition of Symbiomix and the Solosec franchise significantly expands Lupin’s branded women’s health specialty business, which is presently anchored by Methergine (methylergonovine) tablets,” the company said.

On September 15, 2017, the US FDA approved Symbiomix’s lead product, Solosec (secnidazole) oral granules, for the treatment of bacterial vaginosis (BV) in adult women.

Lupin expects Solosec to be commercially available by mid‐2018.

Solosec has been designated as a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) for the treatment of BV.

QIDP designation is for medications intended to treat serious or life‐threatening infections and makes Solosec eligible for at least 10 years of exclusivity in the United States.

The FDA approval of SolosecTM was supported by a comprehensive set of studies, including two pivotal trials in BV and an open label safety study, which demonstrated efficacy for single‐dose Solosec 2g, the Indian company said.

“Solosec is the first and only single dose oral treatment approved for BV, the most prevalent gynecologic infection in the U.S., affecting 21 million women ages 14 to 49 annually,” it said.

Compliance with the current leading therapy for BV has been shown to be only approximately 50%, and more than 50% of women treated for BV have a recurrence within 12 months.

If left untreated or inadequately treated, BV can increase the risk of contracting sexually transmitted diseases and increase the risk of pre‐term birth. US physicians prescribe more than 6 million prescriptions a year for bacterial vaginosis.

“We are delighted to complete the acquisition of Symbiomix and its SolosecTM brand, which immediately expands Lupin’s US women’s health specialty business into the highly‐complementary gynecological infection sector,” said Vinita Gupta, CEO of Lupin.

“This transaction is an important milestone in the evolution of our Specialty business and gives Lupin a new therapeutic to bring to obstetricians and gynecologists to treat a serious health condition they see frequently in their practices.”

Symbiomix was founded in 2012 by a team of industry professionals and entrepreneurs and was backed by three of the world’s leading healthcare venture capital firms: OrbiMed, F‐Prime Capital Partners, and HBM Partners.