Just a few weeks af­ter the FDA ap­proved Sym­bio­mix Ther­a­peu­tics’ sin­gle-dose an­tibi­ot­ic Solosec (sec­nida­zole) for a com­mon form of gy­ne­co­log­i­cal in­fec­tions, the Amer­i­can arm of In­dia’s Lupin has stepped in to buy the com­pa­ny for $150 mil­lion in cash plus sales mile­stones.

Work­ing on the in­stall­ment plan, Lupin is pay­ing $50 mil­lion up­front for Sym­bio­mix, with the rest spread over an un­spec­i­fied pe­ri­od of time.

Their new an­tibi­ot­ic was giv­en the FDA’s Qual­i­fied In­fec­tious Dis­ease Prod­uct sta­tus, which comes with 10 years of mar­ket ex­clu­siv­i­ty.

Vini­ta Gup­ta

Ear­li­er in Sep­tem­ber Newark, NJ-based Sym­bio­mix out­lined its Phase III da­ta for sec­nida­zole, which in a mod­i­fied in­tent-to-treat pop­u­la­tion of 189 women with bac­te­r­i­al vagi­nosis demon­strat­ed clin­i­cal out­come re­spon­der rates of 53.3% for 2 g sec­nida­zole com­pared with 19.3% for place­bo (p<0.001). The cure rate was 64% for 2 g sec­nida­zole com­pared with 26.4% for place­bo.

Sybio­mix worked with Catal­ent on their man­u­fac­tur­ing op­er­a­tions for the an­tibi­ot­ic, work­ing out of the biotech’s 260,000-square-foot op­er­a­tions in Som­er­set, NJ.

New an­tibi­otics have been com­ing along at a steady pace this year, usu­al­ly from small out­fits like this. The Big Phar­ma crowd still has shown lit­tle in­ter­est in de­vel­op­ing new an­tibi­otics, de­spite a ris­ing tide of drug re­sis­tance. The mar­ket is still dom­i­nat­ed by cheap gener­ics, though a slate of biotechs be­lieve that de­mand will soon catch up to the sup­ply they have in the clin­ic.

“We are de­light­ed to com­plete the ac­qui­si­tion of Sym­bio­mix and its Solose 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, in a state­ment. “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.”

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

Novartis is calling off a UK-based trial for Leqvio in the primary prevention of cardiovascular events in patients with high cholesterol, the company confirmed on Wednesday.

The Swiss pharma giant made the decision after “careful evaluation,” a spokesperson told Endpoints News via email. The trial, dubbed ORION-17, was planned in partnership with England’s National Health Service (NHS) and was part of the company’s strategy to establish Leqvio as a standard of care in cardiovascular disease management.