Pfiz­er jumps in­to the heat­ed PhI­II race for new-wave JAK in­hibitors — but safe­ty frets loom large

Pfiz­er has racked up a pos­i­tive slate of Phase III da­ta for its an­ti-in­flam­ma­to­ry JAK1 in­hibitor abroc­i­tinib (PF-04965842), which the phar­ma gi­ant is hop­ing to steer to the FDA rel­a­tive­ly soon as it looks to get in­to a heat­ed block­buster race that’s been heav­i­ly over­shad­owed by new safe­ty warn­ings for the class.

All we’re get­ting now are some un­spec­i­fied — though promis­ing — re­sults, with the phar­ma gi­ant lay­ing claim to a sta­tis­ti­cal­ly sig­nif­i­cant re­sult against a place­bo for atopic der­mati­tis. Pfiz­er, though, wants to go up against some deeply en­trenched ri­vals in a high­ly com­pet­i­tive field, and there’s no re­al in­sight to of­fer on how that stacks up. 

Abroc­i­tinib is a JAK1 in­hibitor, look­ing to bust in­to a mar­ket dom­i­nat­ed by its own fran­chise drug Xel­janz, with Eli Lil­ly’s Olu­mi­ant an­gling in for a slice of the pie af­ter the FDA ap­proved on the low dose of the drug af­ter ini­tial­ly re­ject­ing it on safe­ty fears. 

The field was rat­tled bad­ly more re­cent­ly when Pfiz­er not­ed that the high dose of their block­buster JAK1/JAK3 in­hibitor Xel­janz was linked to a high­er rate of blood clots and death. That trig­gered reg­u­la­to­ry warn­ings on both sides of the At­lantic as they re­viewed the sit­u­a­tion. And days ago In­cyte an­nounced that it will stop co-fund­ing Olu­mi­ant as ques­tions about the cat­e­go­ry abound.

One of the many ques­tions now is whether the safe­ty is­sue at Pfiz­er will bleed over to Ab­b­Vie, which has its own JAK1, upadac­i­tinib, now un­der reg­u­la­to­ry re­view for rheuma­toid arthri­tis on both sides of the At­lantic. Gilead al­so has a lot rid­ing on fil­go­tinib, wide­ly tapped as a po­ten­tial block­buster in its own right. 

And now Pfiz­er gets to join that ma­jor league crew.

Here’s what we know:

Their drug, des­ig­nat­ed a break­through ther­a­py by the FDA, hit on the pri­ma­ry end­point for the In­ves­ti­ga­tor Glob­al As­sess­ment score of clear or al­most clear skin and a ≥2 point im­prove­ment. The drug al­so scored on the pro­por­tion of pa­tients who achieved at least a 75% or greater change from base­line in their Eczema Area and Sever­i­ty In­dex (EASI) score. “The key sec­ondary end­points were the pro­por­tion of pa­tients achiev­ing a 4 point or larg­er re­duc­tion in itch sever­i­ty mea­sured with the pru­ri­tus nu­mer­i­cal rat­ing scale and the mag­ni­tude of de­crease in the pru­ri­tus and Symp­toms As­sess­ment for Atopic Der­mati­tis.”

Dis­con­tin­u­a­tion rates for the two dos­es test­ed were low­er than in the place­bo arm, but no de­tails on ad­verse events were re­port­ed.

More Phase III re­sults will be avail­able lat­er in the year.

Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

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Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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