Material Addition to Lupin’s Women’s Health Care Portfolio with Newly Approved Solosec™ for Bacterial Vaginosis (BV)
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 from internal funds. The transaction 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.
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 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.”
Indication: SOLOSEC™ (secnidazole) 2g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women.
Important Safety Information
- SOLOSEC is contraindicated in patients with a history of hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives.
- Vulvo-vaginal candidiasis may develop with SOLOSEC and require treatment with an antifungal agent.
- Potential risk of carcinogenicity in patients taking single-dose of SOLOSEC to treat bacterial vaginosis is unclear. Chronic use should be avoided.
- SOLOSEC may pass into breast milk. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC.
- SOLOSEC is a single-dose therapy for oral use. The entire contents of SOLOSEC packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. SOLOSEC is not intended to be dissolved in any liquid.
- In clinical studies, the most common adverse events occurring in (?2%) of patients receiving SOLOSEC 2g oral granules were vulvovaginal candidiasis (9.6%), headache (3.6%), nausea (3.6%), dysgeusia (3.4%), vomiting (2.5%), diarrhea (2.5%), abdominal pain (2.0%), and vulvovaginal pruritus (2.0%).
About Symbiomix Therapeutics, LLC
Symbiomix was founded in 2012 by a team of experienced 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.
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.
Globally, Lupin is the 7th and 6th largest generics pharmaceutical company by market capitalization (June 30th, 2017, Bloomberg) and revenues (March 31st, 2017, Bloomberg) respectively. The Company is the 4th largest pharmaceutical player in the US by prescriptions (Quintiles IMS MAT March 2017); 2nd largest Indian pharmaceutical company by global revenues (March 31st, 2017, Bloomberg); 6th largest generic pharmaceutical player in Japan and 6th largest company in Indian Pharmaceutical Market (Quintiles IMS MAT June 2017).
For the financial year ended 31st March, 2017, Lupin’s Consolidated sales and Net profit stood at Rs. 171,198 million (USD 2.55 billion) and Rs. 25,575 million (USD 381 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinlimited
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