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.”

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.