In­dia’s Lupin bags Sym­bio­mix and its new­ly ap­proved an­tibi­ot­ic for $150M-plus

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.”

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Prahlad Singh, PerkinElmer

PerkinElmer hits the check­book again, this time dol­ing out $260M for next-gen ther­a­py bioser­vices firm

When PerkinElmer iced a deal to pick up UK gene editing firm Horizon Discovery, it trumpeted its big move into next-gen therapeutics. Now, not content to sit on its laurels, PerkinElmer is dipping into the war chest again, this time for a firm specializing in cutting-edge bioservices.

Life sciences services giant PerkinElmer will shell out $260 million to acquire Lawrence, MA-based Nexcelom Bioscience, which offers clinical services for next-gen cell and gene therapies, immuno-oncology drugs and vaccines, the companies said Thursday.

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