11 October 2017 | News
This is material addition to Lupin’s Women’s Health Care Portfolio
Pharma major Lupin has announced that its US subsidiary, Lupin, Inc., has acquired Symbiomix Therapeutics, LLC.
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 from internal funds.
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.
SOLOSEC (secnidazole) 2g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women
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’s Solosec will 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 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.
Vinita Gupta, CEO of Lupin said, “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.”
“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”, she added.