Astel­las swoops in on a mid-stage drug for hot flash­es in $860M biotech buy­out deal

Astel­las Phar­ma’s Illi­nois cam­pus

Three months af­ter the Bel­gian biotech Oge­da re­port­ed solid­ly pos­i­tive da­ta from a Phase IIa study of its ex­per­i­men­tal, non-hor­mon­al ther­a­py for hot flash­es re­lat­ed to menopause, the com­pa­ny is be­ing bought out with a hefty cash pay­ment of €500 mil­lion along with a com­mit­ment for €300 mil­lion more in mile­stones (or about $860 mil­lion to­tal).

Jean Com­bal­bert, Oge­da

Japan’s Astel­las has swooped in to make the buy­out, ob­vi­ous­ly im­pressed with da­ta that showed a 93% re­duc­tion in hot flash­es for the fe­zo­line­tant group at week 12 com­pared to 54% on place­bo. The re­duc­tion in sever­i­ty of hot flash­es at week 12 was 70% for the drug arm and 23% in the place­bo group.

At the time of the read­out ear­ly in the year, which was ap­par­ent­ly large­ly over­looked at the time, the prin­ci­pal in­ves­ti­ga­tor not­ed that 20% to 30% of women who de­vel­op hot flash­es dur­ing menopause (80% of all women) seek treat­ment for the con­di­tion due to the sever­i­ty of the symp­toms.

The drug, which Oge­da says it dis­cov­ered and was steer­ing in­to Phase IIb, is a GPCR an­tag­o­nist that tar­gets the tachykinin NK3 re­cep­tor, act­ing on “spe­cif­ic neu­rons that con­trol body tem­per­a­ture to mim­ic the ef­fects of es­tro­gen, but in a non-hor­mon­al man­ner, to di­rect­ly and safe­ly ad­dress the ba­sis for HF in menopausal women.”

Jean Com­bal­bert, CEO of Oge­da, said:

We wel­come the ac­qui­si­tion by Astel­las and look for­ward to de­vel­op­ing fe­zo­line­tant, first non-hor­mon­al treat­ment of Hot Flash­es (HF)/ MR-VMS, in­side a lead­ing glob­al phar­ma­ceu­ti­cal com­pa­ny. With its strong de­vel­op­ment and com­mer­cial­iza­tion ca­pa­bil­i­ties, re­sources and vi­sion, I am con­vinced that Astel­las will be able to turn fe­zo­line­tant promis­ing clin­i­cal re­sults in­to near-term val­ue for pa­tients.

Vesal­ius Bio­cap­i­tal II Part­ners, SRIW SA, BNP Paribas For­tis Pri­vate Eq­ui­ty, and Capri­corn Health-Tech Fund NV par­tic­i­pat­ed in a €16 mil­lion Se­ries B round in 2015, in­di­cat­ing that in­vestors did very well on this deal.

At the time the com­pa­ny was called Eu­ro­screen and then changed the name to Oge­da. The biotech part­nered with Mer­ck in 2014.

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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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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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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Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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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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Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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