Lupin said today it has acquired Symbiomix Therapeutics for $150 million cash, in a deal designed to expand the buyer’s branded women’s health specialty drug business.
In acquiring Symbiomix through its U.S. subsidiary, Lupin has exercised an option it retained earlier this year to buy the privately held developer of treatments for gynecologic infections.
Lupin exercised its option just three weeks after the FDA on September 15 approved Symbiomix’s lead product Solosec™ (secnidazole) 2g oral granules. Solosec is a 5-nitroimidazole antimicrobial agent that is the first and only single-dose oral treatment approved for bacterial vaginosis (BV) in adult women. Lupin said today it expected Solosec to be commercially available by mid 2018.
When it reaches the market, Solosec will enjoy at least 10 years of market exclusivity in the U.S., Lupin said, because the FDA has designated the drug as a Qualified Infectious Disease Product (QIDP) for the treatment of BV. The designation entitles recipient drug developers to faster FDA reviews and adds five additional years of exclusivity.
The FDA approved Solosec based on successful efficacy results for the 2g single dose of the drug in an open label safety study and two Phase III trials in BV, which according to the U.S. Centers for Disease Control and Prevention is the most common vaginal infection in women ages 15 to 44.
64% Clinical Cure Rate
In one pivotal study (SYM-1219-301) assessing the drug in a modified intent-to-treat (mITT) population of 189 women, clinical cure rates based on the 2016 FDA guidance of 7 to 14 days after treatment were 64.0% for 2g Solosec compared with 26.4% for placebo, Symbiomix said on September 6.
Clinical outcome responder rates were 53.3% for 2g Solosec compared with 19.3% for placebo. The clinical outcome responder rate analysis was 58.9% for 2g Solosec compared with 24.6% for placebo when women with abnormal discharge that is inconsistent with BV were included as clinical outcome responders.
More encouraging, Symbiomix added, significantly more patients receiving single-dose secnidazole 2g compared to placebo required no additional BV treatment—68.0% vs. 29.6%.
Lupin agreed to pay $50 million upfront for Symbionix, with the remainder to be paid over time.
The acquisition will reshape Lupin’s branded women’s health specialty business, which at present is anchored by Methergine® (methylergonovine) tablets—which Lupin acquired when it bought GAVIS Pharmaceuticals for $880 million in a deal completed in March 2016.
According to its Annual Report 2017, Methergine and a second GAVIS treatment, methylphenidate, generated a combined $44 million in revenues last year, resulting in an 86% increase in U.S. branded drug business revenues to $78 million; revenues were not broken down individually.
“We are delighted to complete the acquisition of Symbiomix and its Solosec™ brand, which immediately expands Lupin’s U.S. women’s health specialty business into the highly complementary gynecological infection sector,” Lupin CEO Vinita Gupta said in a statement. “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.”