Dai­ichi Sankyo shakes up its R&D lead­er­ship, dis­patch­ing Ju­nichi Ko­ga to the US to run glob­al ops

Two years af­ter bring­ing out the bud­get ax and shak­ing up its glob­al R&D group, Dai­ichi Sankyo is re­vamp­ing the lead­er­ship of its re­search arm and shift­ing the cen­ter of grav­i­ty to the US. They’re al­so sharp­en­ing their fo­cus on on­col­o­gy at a time the pur­suit of new can­cer drugs has gripped most of the ma­jors.

Out: Glenn Gorm­ley, who took the R&D reins at Dai­ichi Sankyo in 2011 af­ter a 20-year run at three big phar­ma groups: Mer­ck, As­traZeneca and No­var­tis. He’ll stay on, though, as chair­man of the board and spe­cial ad­vis­er to glob­al CEO Jo­ji Nakaya­ma.

Ju­nichi Ko­ga

In: Ju­nichi Ko­ga, who’s get­ting a pro­mo­tion from head of the R&D group in Japan to the over­all chief’s po­si­tion. Ko­ga is mov­ing to Bask­ing Ridge, NJ — where the phar­ma com­pa­ny con­cen­trat­ed its US com­mer­cial and re­search work close to 3 years ago — to lead the glob­al op­er­a­tions. And he’ll co-chair the re­search com­mit­tee with An­toine Yver, who heads up on­col­o­gy.

Ken Keller

Com­mer­cial chief Ken Keller, mean­while, is be­ing made CEO of the US op­er­a­tions of Dai­ichi Sankyo, where he will be ex­pect­ed to co­or­di­nate the launch of the com­pa­ny’s new­ly de­vel­oped can­cer drugs.

Jo­ji Nakaya­ma

The se­nior lev­el shake­up is de­signed to fa­cil­i­tate a more ef­fec­tive launch of new drugs, an is­sue that the com­pa­ny has long strug­gled with. The com­pa­ny has an FDA-des­ig­nat­ed “break­through” drug called pex­i­dar­tinib un­der re­view at the agency for treat­ing rare cas­es of tenosyn­ovial gi­ant cell tu­mor. And it’s boast­ed of some so-so da­ta on an­oth­er “break­through” — quizar­tinib, ob­tained in their ac­qui­si­tion of Am­bit. The com­pa­ny has al­so bailed on a pact with Nek­tar on Onzeald and con­ced­ed a painful set­back on its Duchenne mus­cu­lar dy­s­tro­phy drug.

A cou­ple of years ago Dai­ichi Sankyo shut­tered a cou­ple of large re­search groups in In­dia and Japan, lay­ing off hun­dreds of staffers and re­dis­trib­ut­ing their work. The ma­jor fo­cus now clear­ly lies on the US mar­ket and their prospects in on­col­o­gy.

Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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UP­DAT­ED: 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.

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Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017.  Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer and Amarin.

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.

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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.

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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.

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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.

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