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, Solosec 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.
Image: Lupin has acquired US-based Symbiomix and its bacterial vaginosis drug, Solosec. Photo: courtesy of Stuart Miles/FreeDigitalPhotos.net.