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.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

UP­DAT­ED: Bris­tol My­ers Squibb com­mits $300 mil­lion to com­bat racial dis­par­i­ties, but de­clines to re­lease own de­mo­graph­ic da­ta

After the police killing of George Floyd, a flurry of pharma and biotech companies, executives and investors jumped out to make statements, either expressing support for Black Lives Matter and the protests or condemning systemic racism.

Now, a Big Pharma company is publicly putting some teeth behind those statements. This morning, Bristol Myers Squibb announced they would spend $300 million on a broad effort to reduce racial health disparities, and diversify both their clinical trials and their own executive team and workforce.

Martin Shkreli (AP Images)

Mar­tin Shkre­li's in­fa­mous Dara­prim falls off top 20 most ex­pen­sive drugs list

Martin Shkreli incited a national uproar five years ago when he raised the price of Daraprim by a factor of 56 essentially overnight from $13.50 to $750 per pill. Now that the “Pharma Bro’s” high-priced project has received a generic, it no longer places among the most expensive drugs in the world.

GoodRx is back with the latest update of the top 20 most expensive drugs and Daraprim’s exclusion marks the biggest change. The drug had previously ranked seventh on the list’s last iteration, which came in February before the world went into quarantine. Another of Shkreli’s former companies, Retrophin, saw its Chenodal drug place in the top 10 again.

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