Bio­gen is hus­tling a schiz­o­phre­nia drug in­to PhI­Ib af­ter Pfiz­er lets it go in $590M CNS fire sale

Pfiz­er’s $PFE de­ci­sion to beat a re­treat from its pipeline of neu­ro­sciences drugs has trig­gered its first as­set sale.

Michael Ehlers, Bio­gen

Bio­gen $BI­IB is step­ping up with $75 mil­lion in cash and com­mit­ting up to $515 mil­lion in mile­stones to seal the deal on Pfiz­er’s schiz­o­phre­nia drug PF-04958242. The drug has been through an ear­ly-stage study, and now Bio­gen will add it to a lean pipeline of CNS ther­a­pies.

Bio­gen says this marks their first en­try in­to neu­ropsy­chi­a­try.

The drug is an AM­PA re­cep­tor po­ten­tia­tor, de­signed to un­scram­ble ex­ci­ta­to­ry synap­tic trans­mis­sion in the CNS. In the Phase Ib, re­searchers re­port­ed that they were able to suc­cess­ful­ly treat health vol­un­teers by first trig­ger­ing cog­ni­tive is­sues com­mon­ly as­so­ci­at­ed with schiz­o­phre­nia by dos­ing them with ke­t­a­mine and then fol­low­ing up with the ther­a­py. And that built on the ro­dent da­ta they had gath­ered in an­i­mal stud­ies.

Pfiz­er an­nounced in ear­ly Jan­u­ary that it was aban­don­ing neu­ro­sciences R&D and lay off 300 staffers af­ter a long and un­suc­cess­ful at­tempt to build a port­fo­lio of drugs. The phar­ma gi­ant’s web­site list­ed 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.

Bio­gen, mean­while, is boost­ing its neu­rode­gen­er­a­tion work, fo­cus­ing much of its at­ten­tion around the late-stage Alzheimer’s drug ad­u­canum­ab. An­a­lysts have been look­ing for the biotech play­er to make a land­mark deal, but have been dis­ap­point­ed on that score so far. And they were not par­tic­u­lar­ly ex­cit­ed by Bio­gen’s step here to­wards a more holis­tic CNS fu­ture. Baird’s Bri­an Sko­r­ney not­ed:

The crit­i­cal is­sue for Bio­gen right now is how to grow the core busi­ness in­to and through ad­u­canum­ab’s Phase III read­outs. With pres­sures in MS con­tin­u­ing to grow in­to 2019 with Gilenya go­ing gener­ic and po­ten­tial ozan­i­mod ap­proval, and ad­vances by AveX­is in SMA, the Street wants to see de­fin­i­tive moves by Bio­gen to fill po­ten­tial gaps in MS and pro­tect the Spin­raza fran­chise.

Bio­gen, though, isn’t fret­ting pub­licly.

“When cog­ni­tion is im­paired, you lose the abil­i­ty to make sense of the world. Things we of­ten take for grant­ed in our dai­ly lives, in­clud­ing pro­cess­ing in­for­ma­tion, plan­ning and re­mem­ber­ing, all be­come dif­fi­cult or im­pos­si­ble,” said Bio­gen R&D chief Michael Ehlers. “Cog­ni­tion can be im­paired in mul­ti­ple neu­ro­log­i­cal and neu­ropsy­chi­atric dis­eases, in­clud­ing schiz­o­phre­nia. And we know that the ex­tent of cog­ni­tive deficits in pa­tients with schiz­o­phre­nia is a strong pre­dic­tor of dai­ly func­tion­ing. We look for­ward to quick­ly pur­su­ing de­vel­op­ment of this po­ten­tial in­no­v­a­tive ther­a­py to treat such a dev­as­tat­ing dis­ease.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

GSK 'Target the Future' Ad Campaign

Glax­o­SmithK­line's friend­ly ‘shark tank’ crowd­sources ideas for mul­ti­ple myelo­ma, kicks off big­ger push

GlaxoSmithKline is inviting everyone to its friendly shark tank. Its “Think Tank” challenge launching today aims to gather the best pitches for ideas in multiple myeloma with a final pitch-off “Shark Tank” TV show-style finish next year.

The innovation contest kicks off GSK’s bigger “Target the Future” unbranded campaign to advance innovation and awareness in multiple myeloma.

“We have a good sense of where the unmet need lies and what tools may be welcomed by this community, and we’ll continue to do that as part of this program, but the ‘Think Tank’ kickoff is to bring new ideas to the table — things that come from a more grassroots perspective than a large pharma perspective,” Christine Roth, senior VP and global head of oncology at GSK, said.

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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