William Heiden, AMAG

Cred­i­bil­i­ty shred­ded, AM­AG jet­ti­sons CEO and 2 drugs as it looks to re­or­ga­nize around a sal­vage plan

With its rev­enue num­bers in a tail­spin and a top drug un­der crit­i­cal re­view at the FDA fol­low­ing a failed con­fir­ma­to­ry study, AM­AG is start­ing the new year with a new plan.

Out go two drugs for women’s health: the con­tro­ver­sial Vyleesi ap­proved last year to stim­u­late women’s sex­u­al de­sire and In­trarosa for the re­lief of pain dur­ing sex. The biotech $AM­AG plans to auc­tion off those drugs to any­one game to try to mar­ket them. Al­so out: CEO William Hei­den, once they find a suc­ces­sor for the helm.

Hei­den is fol­low­ing in the re­treat­ing foot­steps of 110 sales staffers who were cut last year dur­ing an ear­li­er re­or­ga­ni­za­tion.

The CEO had this to say in a pre­pared state­ment:

We con­tin­ue to be­lieve in the sig­nif­i­cant long-term po­ten­tial of In­trarosa and Vyleesi. How­ev­er, the un­cer­tain­ty around the long-term dura­bil­i­ty of Mak­e­na rev­enues makes it chal­leng­ing to in­vest in both our promis­ing pipeline and in the physi­cian and con­sumer mar­ket­ing re­quired to sup­port these two new prod­ucts.

AM­AG has been un­der con­sid­er­able scruti­ny since a ma­jor­i­ty of FDA ad­vis­ers vot­ed to sug­gest that the agency should yank their ap­proval for Mak­e­na. The drug flopped bad­ly in the con­fir­ma­to­ry study the FDA had de­mand­ed as it pro­vid­ed an ac­cel­er­at­ed OK on the drug — way back in 2011.

Now per­suad­ing the FDA to keep the preterm birth drug Mak­e­na on the mar­ket is a top pri­or­i­ty, along with the de­vel­op­ment of cira­paran­tag and AM­AG-423 while “dri­ving the con­tin­ued growth of Fer­a­heme, which funds our two pipeline as­sets.”

An­a­lysts re­mained skep­ti­cal af­ter the an­nounce­ment Thurs­day.

Eun Yang at Jef­feries says sell­ing off the two un­der-per­form­ing as­sets made sense, but didn’t see any quick up­side in terms of rev­enue. The biotech has lost cred­i­bil­i­ty in re­cent years.

Note that in ear­ly-2017, when AM­AG ac­quired Vyleesi ($60M up­front) & In­trarosa ($50M in cash + $13.5M in stock up­front), the Street was gen­er­al­ly skep­ti­cal of the com­mer­cial po­ten­tial and the shares sold off >30% dur­ing that pe­ri­od. From 2016-2019, to­tal rev­enues de­clined by ~40% to ~$325M (our es­ti­mate) & non-GAAP OpEx in­creased by 37% to ~$387M (by our es­ti­mate).

The new CEO is go­ing to have quite a chal­lenge win­ning an­a­lysts back.

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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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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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slapdown, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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