Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi to pay $2.9B for Proven­tion Bio and its di­a­betes-de­lay­ing drug Tzield

Sanofi and Proven­tion Bio have made a $2.9 bil­lion deal for the French drug­mak­er to ac­quire the biotech, which last year won ap­proval for its drug to de­lay the on­set of type 1 di­a­betes.

Sanofi will pay $25 a share, the com­pa­nies an­nounced in a press re­lease, a 273% pre­mi­um over the New Jer­sey-based biotech’s clos­ing price Fri­day. The com­pa­nies al­ready had a deal for Sanofi to co-pro­mote the drug in the US, which they struck in Oc­to­ber, that gave Sanofi first dibs on ne­go­ti­at­ing any li­cens­ing rights for the drug.

The news is like­ly to be well-re­ceived by the mar­ket, es­pe­cial­ly af­ter the fail­ure of Sil­i­con Val­ley Bank last week sent wor­ries rip­pling through pub­lic and pri­vate biotech com­pa­nies about the in­dus­try’s sta­bil­i­ty.

Proven­tion Bio’s treat­ment, sold as Tzield, was ap­proved by the FDA in No­vem­ber af­ter show­ing in tri­als that it could de­lay the on­set of type 1 di­a­betes by about two years, the first treat­ment to show such an ef­fect. It priced the drug at $193,000 for a course of treat­ment.

In 2019, Sanofi end­ed its re­search in di­a­betes, part of a broad pipeline over­haul to fo­cus the com­pa­ny on ar­eas such as can­cer, rare dis­ease, in­flam­ma­to­ry con­di­tions and oth­er ar­eas. Its di­a­betes drugs ac­count for bil­lions of dol­lars in sales, but the mar­ket for those prod­ucts has been through a volatile pe­ri­od with ex­treme price pres­sure from US politi­cians, while its biggest ri­vals — Eli Lil­ly and No­vo Nordisk — brought block­buster-to-be weight loss drugs to mar­ket.

In its state­ment an­nounc­ing the deal, Sanofi framed the takeover as one that  “builds on Sanofi’s mis­sion to de­liv­er best- and first-in-class med­i­cines and res­onates with our pur­pose of chas­ing the mir­a­cles of sci­ence.” The com­pa­ny al­so still has com­mer­cial in­fra­struc­ture sup­port­ing its di­a­betes prod­ucts, and the com­pa­nies were work­ing to­geth­er to sell the drug al­ready.

Paul Spit­tle

“We al­ready have the com­mer­cial foot­print, which is why we think this is such a good strate­gic fit,” Paul Spit­tle, Sanofi’s chief com­mer­cial of­fi­cer for its gen­er­al med­i­cine di­vi­sion, said in an in­ter­view. “It doesn’t mean there’s any change to our ther­a­peu­tic area pri­or­i­ti­za­tion.”

Tzield is cur­rent­ly ap­proved for adult and some pe­di­atric pa­tients with stage 2 type 1 di­a­betes, mean­ing they are asymp­to­matic but are hav­ing blood sug­ar is­sues. Proven­tion is run­ning a Phase III tri­al, PRO­TECT, to as­sess the treat­ment in new­ly di­ag­nosed pa­tients. A read­out of that tri­al is ex­pect­ed in the sec­ond half of this year and could be im­por­tant for ex­pand­ing the mar­ket for the drug.

Proven­tion and Sanofi’s launch of Tzield be­gan in earnest at the start of the year, SVB Se­cu­ri­ties an­a­lysts said in a note last month, and the biotech has yet to re­port how the drug has been sell­ing in its first months on the mar­ket.

As Sanofi has got­ten to know the com­pa­ny and the drug bet­ter, “we’ve be­come in­creas­ing­ly en­thu­si­as­tic about the op­por­tu­ni­ty it­self,” Spit­tle said. “We think the best op­tion is for Sanofi to own the glob­al rights.”

He de­clined to say whether there were oth­er bid­ders in the process.

Ed­i­tor’s note: This sto­ry was cor­rect­ed af­ter the type of pa­tient el­i­gi­ble for the drug was de­scribed in­cor­rect­ly. 

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

Editor’s note: This is a live story and will be updated.

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.