Mallinck­rodt be­comes the lat­est vic­tim of the FDA's pan­dem­ic-re­lat­ed de­lays as it push­es off ap­pli­ca­tion for skin graft

With Covid-19 lock­ing down trav­el across the world, not even drug safe­ty reg­u­la­tors have been spared from cost­ly de­lays. For the FDA, whose in­spec­tion sched­ule keeps the trains on time for new mar­ket­ing ap­provals, those de­lays are con­tin­u­ing to prove cost­ly.

The FDA has pushed re­view of Mallinck­rodt’s al­lo­gene­ic skin graft for burns, dubbed Strat­a­Graft, af­ter the agency ad­mit­ted it wasn’t able to con­duct a plant in­spec­tion in the need­ed time­frame for a de­ci­sion, the drug­mak­er said last week.

Steven Ro­mano

Mallinck­rodt tied the de­lay to “Covid-19 trav­el re­stric­tions” and said it had no hang-ups about its graft’s chances at an ap­proval.

“We are con­fi­dent in the ef­fi­ca­cy and safe­ty of Strat­a­Graft for the treat­ment of deep par­tial-thick­ness burns based on our piv­otal Phase 3 clin­i­cal tri­al re­sults,” CSO Steven Ro­mano said in a re­lease. “We plan to work close­ly with the FDA to com­plete the re­view and sched­ule its site in­spec­tion.”

With the pan­dem­ic con­tin­u­ing to rage, the FDA has been forced to pri­or­i­tize planned in­spec­tions for new drug ap­pli­ca­tions. Of­ten, that sys­tem has fa­vored drug­mak­ers with new mol­e­cules with a high clin­i­cal need and shoved to the side low­er-im­por­tance prod­ucts, par­tic­u­lar­ly in aes­thet­ics.

In late No­vem­ber, the FDA de­layed its re­view of Re­vance’s frown-line in­jec­tion dax­i­bot­u­linum­tox­i­nA, say­ing it didn’t have enough time to look over its Newark, Cal­i­for­nia, man­u­fac­tur­ing fa­cil­i­ty on time. In Oc­to­ber, the agency pushed back Spec­trum’s neu­trope­nia can­di­date Rolon­tis af­ter of­fi­cials twice de­layed a plant in­spec­tion of South Ko­rea’s Han­mi, which holds the drug’s li­cense.

Mean­while, in­spec­tion de­lays have al­so nixed time­ly ap­provals for big­ger-name prod­ucts as well. The FDA re­peat­ed­ly de­layed a site in­spec­tion for Bris­tol My­ers Squibb’s liso-cel, even­tu­al­ly con­duct­ing a site vis­it at Lon­za Hous­ton’s con­tract site in De­cem­ber that re­sult­ed in a Form 483. That de­lay pushed liso-cel’s ap­proval past the Dec. 31 cut­off point tied to a $9 CVR in­vestors held from Bris­tol’s ac­qui­si­tion of Cel­gene.

Lon­za af­ter the fact said the FDA’s de­lays didn’t give ei­ther com­pa­ny enough time to ad­dress any par­tic­u­lar man­u­fac­tur­ing is­sues, which are quite com­mon for CAR-Ts on the whole. Liso-cel was even­tu­al­ly ap­proved ear­li­er this month and will be mar­ket­ed as Breyanzi.

The top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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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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CMO Levi Garraway (Genentech)

Fo­cus­ing on the bright side, FDA OKs Roche's Actem­ra for rare lung dis­ease de­spite PhI­II flop

Actemra’s failure to hit the primary endpoint in a Phase III study didn’t stop the FDA from granting Roche priority review. And it’s certainly not standing in the way of a sixth approval for Roche’s IL-6 drug.

Regulators have cleared Actemra, or tocilizumab, for systemic sclerosis-associated interstitial lung disease in adult patients. Roche’s big Genentech subsidiary notes that it is the first biologic approved for this rare disease.

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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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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