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.”

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Andrea Pfeifer, AC Immune CEO (AC Immune)

Look­ing to repli­cate Covid-19 suc­cess in neu­ro, BioN­Tech back­ers bet on AC Im­mune and its new­ly-ac­quired Parkin­son's vac­cine

The German billionaires behind BioNTech have found a new vaccine project to back.

Through their family office Athos Service, twin brothers Thomas and Andreas Strüngmann are leading a $25 million private placement into Switzerland’s AC Immune — which concurrently announced that it’s shelling out $58.7 million worth of stock to acquire Affiris’ portfolio of therapies targeting alpha-synuclein, including a vaccine candidate, for Parkinson’s disease.

Christophe Weber, Takeda CEO (Kyodo via AP Images)

Take­da flesh­es out CNS pact with pep­tide drug­mak­er, set­ting aside $3.5B in fu­ture mile­stones

One of a suite of drugmakers looking to reinvest in the neuroscience space, Takeda has been aggressive in signing on new partners to help build up its pipeline in that space. But sometimes the best partner is the one you already have.

Takeda will set aside $3.5 billion in future milestones and an undisclosed upfront payment to build out its drug discovery deal with Japanese peptide conjugate maker PeptiDream, adding neurodegeneration to the partnership’s list of CNS targets, the companies said Tuesday.

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Michael Henderson, BridgeBio CBO

Bris­tol My­ers Squibb catch­es the SHP2 wave in a new col­lab­o­ra­tion deal with Bridge­Bio

Once considered “undruggable,” the phosphatase enzyme SHP2 has seen recent interest from a suite of Big Pharmas, including AstraZeneca, Amgen, Novartis and Merck. Now Bristol Myers Squibb is getting in on the action, with a deal to pair its PD-1 superstar Opdivo with BridgeBio’s SHP2 inhibitor for difficult-to-treat cancers.

BMS and BridgeBio took the wraps off the non-exclusive, co-funded collaboration early Tuesday morning. The “catalyst,” BridgeBio CBO Michael Henderson said, was last year’s virtual JP Morgan conference, where the companies met to discuss early preclinical results they were seeing between SHP2 and immuno-oncology therapies.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.