Mumbai-based Lupin’s US subsidiary has acquired Symbiomix Therapeutics for $150m in an all-cash deal to expand its branded women’s health specialty business.
Founded in 2012, Symbiomix Therapeutics, which is based in Newark, New Jersey, is focused on developing therapies for gynecologic infections that can have serious health implications.
Through its acquisition, Lupin adds Symbiomix’ lead candidate Solosec (secnidazole) oral granules. Solosec, a 5-nitroimidazole antimicrobial agent, had secured the approval from the US Food and Drug Administration (FDA) for the treatment of bacterial vaginosis (BV) in adult women.
Solosec’s approval in the US was backed by various studies including two key trials in bacterial vaginosis along with an open label safety study which proved efficacy for single-dose of the drug in 2g strength.
According to Lupin, Solose is the first and only single dose oral treatment indicated for bacterial vaginosis, a very common gynecologic infection in the US, annually affecting 21 million women aged between 14 and 49.
Lupin CEO Vinita Gupta 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.”
Lupin anticipates the commercial launch of Solosec in the US to be in mid-2018. The drug has been given a Qualified Infectious Disease Product (QIDP) designation by the FDA for bacterial vaginosis. With the QIDP, Solosec will be eligible for a minimum of 10 years of exclusivity in the US.
The bacterial vaginosis drug will join Methergine (methylergonovine) tablets, regarded as the anchor of Lupin’s branded women’s health specialty business.
Source: PBR
Echosens, a high-technology company offering liver diagnostic solutions, and Novo Nordisk A/S, a leading global healthcare company, announced a partnership to advance early diagnosis of non-alcoholic steatohepatitis (NASH) and increase awareness of the disease among patients, healthcare providers and other stakeholders.
Positive opinion based on Phase 3 ADAPT trial showing efgartigimod provided clinically meaningful improvements in strength and quality of life measures. If approved, efgartigimod will be the first neonatal Fc receptor (FcRn) blocker for the treatment of adults in Europe living with rare neuromuscular disease generalized myasthenia gravis (gMG).
Galapagos CEO Paul Stoffels, M.D., has finally taken the plunge on M&A. The newly minted chief executive has signed not one but two deals in an attempt to right the ship, bringing two small biotechs aboard for a combined 239 million euros ($251.4 million).