New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last Sep­tem­ber, when Pfiz­er cel­e­brat­ed pos­i­tive da­ta from a sec­ond Phase III study of abroc­i­tinib, many watch­ers ap­plaud­ed the ef­fi­ca­cy but were still wait­ing to see whether the JAK1 in­hibitor is “safe enough to be a for­mi­da­ble com­peti­tor to Dupix­ent,” the clear leader in the atopic der­mati­tis field. The full slate of safe­ty da­ta are now out and, ac­cord­ing to one an­a­lyst, the an­swer is: prob­a­bly not.

The broad­er class of JAK in­hibitors has been plagued by se­ri­ous side ef­fects re­lat­ing to blood that threat­en to lim­it their adop­tion, and JAK1 drugs — which tar­get a more spe­cif­ic sub­type of the ki­nase — are still un­der heavy scruti­ny.

In a note, Jef­feries’ Re­gen­eron bull Biren Amin sin­gled out re­duc­tions in platelet count in JADE MONO-2 as a par­tic­u­lar cause for con­cern.

At week 4, platelet re­duc­tions of 26% were not­ed for the 200mg dose, 19% in the 100mg group, and less than 1% for those on place­bo. In the drug’s de­fense, the re­searchers wrote that platelet counts “re­turned to­wards base­line val­ues there­after de­spite con­tin­u­a­tion of treat­ment,” and that there were no re­ports of bleed­ing dis­or­ders in any treat­ment group.

Still, the fact that the mech­a­nism lead­ing to platelet re­duc­tions is un­known could be a con­cern, Amin not­ed.

Then there’s the da­ta point that 1.9% of pa­tients in the 100mg group re­port­ed a se­ri­ous in­fec­tion, com­pared to none on 200mg and 1.3% on place­bo. Her­pes zoster was ob­served in 2 pa­tients tak­ing 200mg (1.3%).

In Ab­b­Vie’s case, Amin point­ed out, 1% of pa­tients re­port­ing se­ri­ous in­fec­tions, op­por­tunis­tic in­fec­tions and her­pes zoster was enough for reg­u­la­tors to slap a black box warn­ing on Rin­voq’s rheuma­toid arthri­tis la­bel.

“Tak­en to­geth­er, giv­en the safe­ty sig­nals around con­cerns for JAK1i class, ini­tial adop­tion of abroc­i­tinib might be lim­it­ed to se­vere pa­tients or on­ly be used as a short course of in­duc­tion be­fore switch­ing pa­tients to oth­er ther­a­pies to re­duce the ex­po­sure,” he wrote.

For now, Pfiz­er is fo­cus­ing on the bright side, em­pha­siz­ing how abroc­i­tinib can of­fer po­ten­tial symp­tom re­lief to pa­tients — in­clud­ing the both­er­some itch that comes with mod­er­ate to se­vere atopic der­mati­tis. The rate of ad­verse events over­all was al­so low in the tri­al, back­ing the claim that the drug was well-tol­er­at­ed. Abroc­i­tinib is al­so giv­en in pill form rather than sub­cu­ta­neous­ly, of­fer­ing pa­tients a more con­ve­nient choice.

But as Sanofi and Re­gen­eron con­tin­ue to groom Dupix­ent — the prize gem of a fore­gone re­la­tion­ship that gen­er­at­ed $2.32 bil­lion in 2019 rev­enue — in­to an even big­ger block­buster, the fight is on­ly be­gin­ning to play out.

Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

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Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

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Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

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David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

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Nadim Ahmed (Bristol Myers Squibb)

Bris­tol My­er­s' top hema­tol­ogy ex­ec is on his way out — right on the heels of a $6B CVR im­plo­sion

Fourteen days after the $6.3 billion CVR tied to the approval of liso-cel went up in smoke, one of the top execs in charge of the work at Bristol Myers Squibb is preparing to step out of his job.

Mizuho analyst Salim Syed, who’s been following every twist and turn in the CVR saga, told investors on Thursday morning that Nadim Ahmed is on his way out. Syed’s note:

Recall, Ahmed is EVP and President of Hematology at BMY (i.e. JCAR017 and bb2121 are both hematological drugs). He’s still listed on the BMY management page. This is true — he’s still technically there. However, I have confirmed w/ BMY that his last day is tomorrow, Friday 1/15. To my best knowledge, Ahmed does not have another job lined up post his departure tomorrow.

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UP­DAT­ED: Am­gen tops cost watch­dog's price gougers list based on 'un­sup­port­ed' in­creas­es for En­brel with­out mean­ing­ful da­ta

In a top 10 ranking of the most egregious price gougers from 2019, Amgen’s Enbrel topped US cost watchdog ICER’s naughty list with “unsupported” markups that added as much as $403 million to the nation’s drug spend during that time.

Price increases for some of pharma’s most popular drugs have long been a focus of consumer ire, but the industry has argued those increases are routine and meant to cover the cost of R&D innovation. Without meaningful guidance at the state or federal level, ICER looked to connect how much a drug had progressed in the clinic compared with its increase in both wholesale and net price in 2019.

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News brief­ing: Five Prime fi­nal­izes PhI­II plans for gas­tric can­cer; AI di­ag­nos­tics-fo­cused Paige ex­pands staff

Five Prime Therapeutics has finalized a plan to take their comeback gastric cancer drug into late-stage studies.

The South San Francisco-based biotech released full Phase II data for bemarituzumab on Friday, which Five Prime said in November met all of its pre-specified efficacy endpoints in a topline readout. Now, the company is announcing it plans to launch a Phase III trial for the program in 2021. Following November’s readout, the future of bemarituzumab had not yet been finalized.