Pfiz­er is ax­ing its neu­ro­sciences di­vi­sion, lay­ing off 300 and dis­card­ing new drugs

Pfiz­er is start­ing out 2018 by rip­ping up its ear­ly-, mid-stage and pre­clin­i­cal R&D op­er­a­tions fo­cused on neu­ro­sciences and lay­ing off hun­dreds of work­ers en­gaged in the de­vel­op­ment work.

In a state­ment, Pfiz­er $PFE says it is is ax­ing about 300 work­ers in Con­necti­cut and Mass­a­chu­setts — about 100 each in An­dover, Gro­ton and Cam­bridgewhere it’s been con­cen­trat­ing its R&D ef­forts — and dis­card­ing a slate of Phase I/II and pre­clin­i­cal stud­ies.

Pfiz­er is keep­ing tanezum­ab and its work on Lyri­ca, with ap­pli­ca­tions in epilep­sy. And oth­er rare dis­ease pro­grams in the neu­rol­o­gy field are al­so be­ing re­tained.

Pfiz­er has con­trac­tu­al ties on tanezum­ab that can’t be sim­ply dis­card­ed. Af­ter de­cid­ing to make a come­back run on the an­ti-NGF drug, Pfiz­er li­censed out rights to Eli Lil­ly in a $1.7 bil­lion deal back in 2013. The rest of the ex­per­i­men­tal work is over.

“This was an ex­er­cise to re-al­lo­cate spend across our port­fo­lio,” Pfiz­er not­ed in the state­ment to End­points News, “to fo­cus on those ar­eas where our pipeline, and our sci­en­tif­ic ex­per­tise, is strongest.”

And in lieu of do­ing ac­tu­al re­search in the field, Pfiz­er is set­ting up a ded­i­cat­ed ven­ture fund:

“We rec­og­nize that neu­ro­science is an area of tremen­dous un­met need for pa­tients and we plan to cre­ate a ded­i­cat­ed neu­ro­science ven­ture fund to sup­port con­tin­ued ef­forts to ad­vance the field. More de­tails on the fund will be forth­com­ing this year.”

Big Phar­ma has had a com­pli­cat­ed re­la­tion­ship with neu­ro­sciences, drawn to the po­ten­tial for de­vel­op­ing new block­busters but fre­quent­ly put off by the high fail­ure rates and still hazy sci­ence that backs much of the work.

Mikael Dol­sten

Pfiz­er’s web site lists 8 Phase I and Phase II pro­grams in neu­ro­sciences, its third largest con­cen­tra­tion of pipeline ef­forts. Those drugs in­clude a Phase II GA­BA-A re­cep­tor ag­o­nist PF-06372865 and an­oth­er mid-stage ef­fort on Parkin­son’s dis­ease. There are al­so 4 ear­ly-stage projects on Alzheimer’s.

In the fall of 2016 Pfiz­er re­cruit­ed Har­vard pro­fes­sor Ole Isac­son to head up neu­ro­sciences work, cel­e­brat­ing the com­pa­ny’s com­mit­ment to mak­ing break­through ef­forts on Alzheimer’s and Parkin­son’s. Isac­son, though, qui­et­ly left just 9 months lat­er, in May of last year.

Pfiz­er has been ruth­less when it comes to R&D cuts, slash­ing the bud­get sev­er­al years ago and mak­ing deep cuts at ma­jor re­search hubs in Con­necti­cut and the UK. Chief sci­en­tist Mikael Dol­sten has made it clear that R&D re­or­ga­ni­za­tion is a con­stant, amp­ing up and wind­ing down as the com­pa­ny shifts fo­cus on its most promis­ing prospects. And it’s beefed up R&D spend­ing to about $8 bil­lion last year, the fourth high­est in bio­phar­ma R&D.

Right now, neu­ro­sciences is not one of those ar­eas. A spokesper­son adds that the com­pa­ny plans to shift its R&D bud­get in neu­ro­sciences to oth­er ar­eas where it re­mains fo­cused.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Bris­tol-My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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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.