Boehringer In­gel­heim to cash out Hik­ma stake; Breast can­cer biotech sets terms for IPO

Boehringer In­gel­heim is of­fload­ing a ma­jor chunk of its hold­ing in Hik­ma, propos­ing to sell 28 mil­lion out of 40 mil­lion shares of the Lon­don-list­ed drug­mak­er. The stake is val­ued at near­ly £1 bil­lion, and Hik­ma has com­mit­ted to buy­ing no more than £295 mil­lion of it — which would amount to 4.99% of its stock’s val­ue at the time the deal was un­veiled. The Ger­man phar­ma gi­ant had ob­tained these shares when it sold Rox­ane Lab­o­ra­to­ries to Hik­ma in 2016.

→ Stafford, TX-based Green­wich Life­Sciences has set the price range for its IPO at $7.5 to $8.5, plan­ning to raise $21 mil­lion by sell­ing 2.7 mil­lion shares. Its lead drug is an im­munother­a­py de­signed to pre­vent the re­cur­rence of breast can­cer fol­low­ing surgery — with a Phase III planned for this year. At the mid­point of the range, the val­u­a­tion would be $106 mil­lion.

Cen­tu­ry Ther­a­peu­tics is bring­ing Em­pir­i­ca Ther­a­peu­tics and its glioblas­toma ex­per­tise in­to the fam­i­ly. Found­ed by re­searchers at Mc­Mas­ter Chil­dren’s Hos­pi­tal and the Uni­ver­si­ty of Toron­to, Em­pir­i­ca has iden­ti­fied new tar­gets for en­gi­neered im­mune cells to home in on. It will now be­come a sub­sidiary called Cen­tu­ry Ther­a­peu­tics Cana­da.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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Ab­b­Vie snaps up a bis­pe­cif­ic for mul­ti­ple myelo­ma in TeneoOne buy­out; Ver­tex launch­es $1.5B share buy­back pro­gram

Following a positive interim Phase I readout, AbbVie is exercising an option to acquire TeneoOne and its BCMA candidate TNB-383B for relapsed or refractory multiple myeloma.

AbbVie inked a deal with TeneoOne back in 2019 to develop and commercialize TNB-383B, a bispecific antibody that targets BCMA and CD3. The treatment is designed to direct the body’s immune system against BCMA-expressing tumor cells. And according to interim results, the candidate showed a 79% objective response rate in a Phase I study. Sixty-three percent of patients saw a “very good partial response” or better, and 29% saw a complete response at doses greater than or equal to 40 mg at a median follow-up of 6.1 months.

James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.