AM­AG CMO hits the ex­it just as biotech search­es for new CEO to right a ship rocked by Mak­e­na con­tro­ver­sy

Head­ing in­to 2020, AM­AG Phar­ma­ceu­ti­cals has sketched big plans to sal­vage its wob­bly op­er­a­tions — bat­tling a rev­enue squeeze and a crit­i­cal FDA re­view of its preterm birth drug — un­der a new CEO. To­day, it an­nounced that the chief med­ical of­fi­cer won’t be stay­ing, ei­ther.

Julie Krop

Julie Krop, who joined AM­AG in 2015, will de­camp by the end of the month, leav­ing a void in the biotech’s de­vel­op­ment group just as it pledges to per­suade the FDA to keep Mak­e­na on the mar­ket and ad­vance a “po­ten­tial­ly ex­cit­ing pipeline.”

The biotech has been un­der con­sid­er­able scruti­ny since an ad­vi­so­ry com­mit­tee con­vened by the FDA vot­ed to yank its ap­proval for Mak­e­na. First giv­en an ac­cel­er­at­ed OK in 2011, the drug had failed to prove in a con­fir­ma­to­ry tri­al that it pre­vents preterm birth any more than a place­bo.

In re­sponse to the thumbs down, where votes were split, Krop said her team was work­ing with reg­u­la­tors to gen­er­ate ad­di­tion­al ef­fi­ca­cy da­ta while keep­ing the drug avail­able to pa­tients.

William Hei­den

The fate of Mak­e­na — a ver­sion of an old drug known as 17p — is the sub­ject of a fierce de­bate among doc­tors and in­sur­ers. It’s cur­rent­ly the on­ly op­tion avail­able for at-risk preg­nant women, ad­vo­cates say, and the FDA is man­dat­ed by law to pull gener­ic op­tions along­side the brand­ed one should they de­cide to do so.

Mak­e­na sales took a hit in Q4 of 2019, reg­is­ter­ing at $122.1 mil­lion com­pared to $322.3 mil­lion dur­ing the same pe­ri­od in 2018.

In the wake of the FDA pan­el’s neg­a­tive opin­ion, AM­AG has al­so de­cid­ed to di­vest a pair of women’s health ther­a­pies, name­ly In­trarosa for pain dur­ing sex and Vyleesi, the con­tro­ver­sial sec­ond “fe­male Vi­a­gra” fol­low­ing Ad­dyi.

Adding up all of that trig­gered an im­pair­ment charge of $155 mil­lion. AM­AG ac­quired Vyleesi and In­trarosa in ear­ly 2017 for a to­tal up­front cost of $123.5 mil­lion.

A search for William Hei­den’s suc­ces­sor as CEO is un­der­way, with a tran­si­tion ex­pect­ed in the next quar­ter. His de­par­ture fol­lowed that of 110 sales staffers who were cut dur­ing a sweep­ing re­or­ga­ni­za­tion last year.

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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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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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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Lat­est Mass­Bio re­port shows just how much bio­phar­ma's biggest sec­tor boomed in 2020

It’s clear by now that biopharma experienced a massive boom in 2020, but a new report out Thursday says the Massachusetts hub was particularly successful.

The trade group MassBio released its latest industry snapshot, summarizing the last calendar year as the most successful for the Massachusetts biopharma sector. Overall, Massachusetts-based biotechs raised $5.8 billion in 2020, marking a hefty 93% increase from the previous year.

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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Amid back of­fice con­sol­i­da­tion, Gilead ax­es 179 jobs in Cal­i­for­nia

Gilead is chopping 179 jobs in its home state of California as it scales down its headquarters in favor of a hub in North Carolina.

Up to half of the roles would shift to Research Triangle Park, where the company is setting up a new business services and information technology center, the San Francisco Chronicle reported. The precise number will depend on how many employees choose to relocate.

Per a WARN notice filed with the state, the layoffs are expected to be effective May 30.

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.