Ra­mona Se­queira to be­come PhRMA's first fe­male chair; McK­in­sey reach­es near­ly $574 mil­lion set­tle­ment over in­volve­ment in opi­oid cri­sis

PhRMA is get­ting its first fe­male board chair.

On Thurs­day, the trade as­so­ci­a­tion cel­e­brat­ed news that Ra­mona Se­queira, pres­i­dent of Take­da’s US busi­ness, has been named chair-elect. The for­mer board trea­sur­er is set to step up next year, leav­ing her role to No­var­tis CEO Vas Narasimha.

“Over the past year, the pub­lic has wit­nessed first-hand, the ben­e­fits of in­no­v­a­tive sci­ence as our in­dus­try quick­ly and safe­ly worked to­geth­er to ad­dress one of the great­est health care chal­lenges of our time,” Se­queira said in a state­ment. “Yet, there con­tin­ues to be op­por­tu­ni­ty to im­prove pub­lic per­cep­tion of our in­dus­try.”

Se­queira said build­ing trust across the in­dus­try is a key pri­or­i­ty, “es­pe­cial­ly among com­mu­ni­ties who con­tin­ue to feel the dis­par­i­ties and in­equities of our health care sys­tem.”

The Mc­Mas­ter Uni­ver­si­ty grad has been with Take­da since 2015, where she leads the US busi­ness unit and glob­al port­fo­lio com­mer­cial­iza­tion. Be­fore that, she spent sev­er­al years at Eli Lil­ly in com­mer­cial lead­er­ship and gen­er­al man­age­ment roles span­ning Cana­da, Eu­rope and the US.

Se­queira will re­place Eli Lil­ly CEO David Ricks, who as­sumed his role as board chair back in De­cem­ber.

McK­in­sey reach­es near­ly $574 mil­lion set­tle­ment over in­volve­ment in opi­oid cri­sis

McK­in­sey & Com­pa­ny has agreed to pay near­ly $574 mil­lion to set­tle claims that it helped drug­mak­ers — in­clud­ing Oxy­Con­tin man­u­fac­tur­er Pur­due Phar­ma — ag­gres­sive­ly mar­ket opi­oid painkillers, spurring a dead­ly epi­dem­ic.

The set­tle­ment was reached with at­tor­neys gen­er­al from 47 states, five ter­ri­to­ries and DC. McK­in­sey still de­nies the al­le­ga­tions, and the set­tle­ment con­tains no ad­mis­sion of guilt.

Ac­cord­ing to court doc­u­ments, McK­in­sey sold mar­ket­ing ideas to Pur­due for more than 15 years, in­clud­ing be­fore and af­ter Pur­due’s 2007 guilty plea for felony mis­brand­ing. McK­in­sey al­leged­ly helped Pur­due de­vise plans to “tur­bocharge” sales un­der a strat­e­gy they called “Evolve 2 Ex­cel­lence,” which sig­nif­i­cant­ly in­creased Oxy­Con­tin sales, a doc­u­ment filed in Mass­a­chu­setts court states..

“Ear­ly in their re­la­tion­ship, McK­in­sey ad­vised Pur­due that it could in­crease Oxy­Con­tin sales through physi­cian tar­get­ing and spe­cif­ic mes­sag­ing to pre­scribers,” the doc­u­ment al­leges. “These McK­in­sey strate­gies formed the pil­lars of Pur­due’s sales tac­tics for the next fif­teen years.”

The set­tle­ment mon­ey will be used by the states to ad­dress the im­pact of the opi­oid epi­dem­ic. And McK­in­sey has reaf­firmed that it will no longer ad­vise clients on any opi­oid-re­lat­ed busi­ness any­where in the world.

“”We chose to re­solve this mat­ter in or­der to pro­vide fast, mean­ing­ful sup­port to com­mu­ni­ties across the Unit­ed States. We deeply re­gret that we did not ad­e­quate­ly ac­knowl­edge the trag­ic con­se­quences of the epi­dem­ic un­fold­ing in our com­mu­ni­ties. With this agree­ment, we hope to be part of the so­lu­tion to the opi­oid cri­sis in the U.S.,” McK­in­sey’s glob­al man­ag­ing part­ner Kevin Snead­er said in a state­ment.

Strides de­merges biotech busi­ness un­der Stelis 

Strides Phar­ma Sci­ence — a phar­ma­ceu­ti­cal com­pa­ny based in Ban­ga­lore, In­dia — is de­merg­ing its biotech busi­ness un­der Stelis Bio­phar­ma, it an­nounced on Thurs­day.

The board of di­rec­tors is form­ing a com­mit­tee to “ex­plore var­i­ous op­tions of val­ue dis­cov­ery,” in­clud­ing list­ing the busi­ness on a stand­alone ba­sis, ac­cord­ing to a state­ment.

For rea­son­ing, Strides said that Stelis has com­plet­ed its in­cu­ba­tion phase and is en­ter­ing a growth phase, for which it will need $100 mil­lion to fund pro­grams over the next three years.

“As Strides fo­cus­es on build­ing its Core Phar­ma busi­ness, it will not par­tic­i­pate in the new fund­ing round,” a state­ment read.

Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Gala­pa­gos posts a safe­ty win for fil­go­tinib, but is it too lit­tle, too late?; Bio-Techne inks $320M mol­e­c­u­lar di­ag­nos­tics buy­out

Once a promising $725 million play in immunology, Gilead’s big bet on filgotinib effectively disintegrated in December when the drugmaker reworked its partnership with Galapagos. Now, Galapagos is sporting safety data that will come as a relief — but will it make a difference on filgotinib’s chances in the US?

In a study designed to compare filgotinib’s effect on sperm count with placebo, Galapagos’ JAK inhibitor saw fewer patients post a 50% or more reduction in sperm concentration after 13 weeks of treatment, according to data from the MANTA and MANTA-RAy studies unveiled Thursday.

In the lat­est big in­vest­ment in gene ther­a­py man­u­fac­tur­ing, Bio­gen com­mits $200M to a ma­jor new fa­cil­i­ty in NC

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

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Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Cedric Francois, Apellis CEO (Apellis)

Apel­lis joins the grow­ing num­ber of bio­phar­mas scrap­ping a failed Covid-19 pro­gram af­ter an ear­ly flop

The global pandemic set off a frenzy of R&D activity as biotechs around the world scrambled to see if they could come up with a new medication or vaccine to help fight back. But even as the mRNA standouts are highlighting the market El Dorado open to successful teams, the failures are starting to pile up.

Thursday afternoon it was Apellis’ $APLS turn to deep-six a new drug.

The biotech reports that their C3 therapy APL-9 had failed to move the needle on mortality when combined with standard of care, as compared to SOC alone.