Mumbai: Pharma major Lupin announced that its US subsidiary, Lupin, Inc., has acquired Symbiomix Therapeutics, LLC.
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 has been made 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. The acquisition is funded by internal funds. The transaction was closed.
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.
On September 15, 2017, the USFDA 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 bacterial vaginosis (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 Solosec™ 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. 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.
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 Solosec™ 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.”