With Trump’s new FDA com­mish nom­i­nee loom­ing, in­dus­try ex­ecs are keep­ing their fin­gers crossed for Scott Got­tlieb

Scott Got­tlieb

Last week Pres­i­dent Trump said he was just days away from an­nounc­ing an ab­solute­ly “fan­tas­tic” new FDA com­mis­sion­er. One who would cut up to 80% of the reg­u­la­tions around drug de­vel­op­ment, blaz­ing a short­er path to an ap­proval. One who would get ex­per­i­men­tal meds to dy­ing pa­tients, over­haul­ing time­lines and slash­ing de­vel­op­ment bud­gets.

By and large, the mes­sage has spurred more than a lit­tle trep­i­da­tion in the in­dus­try that the pres­i­dent, who has earned a rep­u­ta­tion for shoot­ing first and ask­ing ques­tions lat­er, was go­ing to rad­i­cal­ly change the ap­proval process at the FDA. And that might in­di­cate that lib­er­tar­i­an “seast­ead­er” Jim O’Neill — who has fa­mous­ly said that drugs should be ap­proved on safe­ty alone — has the in­side track with the new pres­i­dent.

But he’s not the in­dus­try’s first choice. That dis­tinc­tion ap­pears to be re­served al­most en­tire­ly for Scott Got­tlieb, the for­mer deputy com­mis­sion­er at the FDA un­der George W. Bush with a rep­u­ta­tion as a staunch con­ser­v­a­tive with no known ap­petite for toss­ing grenades in­to the reg­u­la­to­ry un­der­brush.

Mizuho Se­cu­ri­ties USA ran a quick sur­vey of 53 drug com­pa­nies ask­ing them which of the four can­di­dates men­tioned so far in the me­dia — Got­tlieb, O’Neill, Bal­a­ji Srini­vasan and Joseph Gul­fo — would get their vote.

Sev­en­ty-two per­cent picked Got­tlieb. The rest were al­so rans. O’Neill got a hand­ful of votes at 8%, with Gul­fo at 9% and Srini­vasan at a mere 2%. (Gul­fo has pro­mot­ed his own can­di­da­cy with­out any in­de­pen­dent con­fir­ma­tion from the Trump ad­min­is­tra­tion that he’s ever been a se­ri­ous can­di­date or been with­in 100 feet of the new pres­i­dent.)

In his week­ly roundup on Fri­day, Baird’s Bri­an Sko­r­ney came to the same con­clu­sion with­out any polling. He wrote: “We be­lieve in­dus­try and in­vestor sup­port is over­whelm­ing­ly in fa­vor of Scott Got­tlieb.”

“He leans right, he’s got ex­pe­ri­ence in the agency, he’s got the M.D. cre­den­tial, and he’s out­spo­ken,” Michael Ga­ba, fed­er­al pol­i­cy leader of law firm Hol­land & Knight’s na­tion­al Health­care & Life Sci­ences Team, told Reuters re­cent­ly.

I asked Ga­ba to elab­o­rate on that. And he sent me this:

When it comes to the FDA, bio­phar­ma, and reg­u­lat­ed in­dus­try as a whole, puts a pre­mi­um on pre­dictabil­i­ty, speed to mar­ket, and the abil­i­ty to make dif­fer­en­ti­at­ing claims in the mar­ket­place about their prod­ucts’ ef­fec­tive­ness to treat and mit­i­gate dis­ease.  Safe­ty is the giv­en once a prod­uct makes it through the FDA, and by it­self doesn’t dis­tin­guish prod­ucts in the mar­ket­place.  Among the FDA com­mis­sion­er can­di­dates we’ve read about, Dr. Got­tlieb is well known to in­dus­try and has the req­ui­site ex­pe­ri­ence and tal­ent to re­form and stream­line the FDA ap­proval process.

The theme among the oth­er can­di­dates ap­pears to be to speed prod­ucts to mar­ket by lim­it­ing the agency’s role to eval­u­at­ing safe­ty on­ly.  Not on­ly would this dy­nam­ic be chal­leng­ing to in­dus­try, providers and pa­tients, it would re­quire a statu­to­ry change to the FD­CA – and we all know that the leg­isla­tive process it­self can be very messy and un­pre­dictable.

Got­tlieb’s nom­i­na­tion would con­tin­ue a long­stand­ing tra­di­tion of nam­ing a trained physi­cian for the top job at the FDA. As a res­i­dent fel­low at the Amer­i­can En­ter­prise In­sti­tute, he’s kept the heat on Oba­macare through a se­ries of op-eds in high pro­file pub­li­ca­tions like the Wall Street Jour­nal. As a ven­ture part­ner at New En­ter­prise As­so­ci­ates he’s a board mem­ber at Me­dA­vante, which mar­kets soft­ware for an­a­lyz­ing clin­i­cal tri­al da­ta. And he’s an ad­vi­sor to Glax­o­SmithK­line, which has shown no ap­petite for rad­i­cal change in the way de­vel­op­ers prove a drug works.

It’s the kind of re­sume that would in­di­cate a sym­pa­thy for con­tin­u­ing to evolve reg­u­la­tions to speed de­vel­op­ment, but with­out any ap­petite for play­ing rev­o­lu­tion­ary.

Of course, that’s one rea­son why he may not get the job. Trump has glee­ful­ly named new cab­i­net mem­bers based on their hos­til­i­ty to the agen­cies they’ll be run­ning and the reg­u­la­tions they’ve been in­volved in cre­at­ing. And his ex­ec­u­tive or­der de­mand­ing the elim­i­na­tion of two rules for every new one un­der­scores his com­mit­ment to elim­i­nat­ing hun­dreds of pages of regs for every one that sur­vives.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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The fu­ture of mR­NA, J&J's vac­cine ad­comm, Mer­ck­'s $1.85B au­toim­mune bet and more

Welcome to the third installment of 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.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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