Richard Francis, new Teva CEO (Novartis via Facebook)

Up­dat­ed: Te­va picks for­mer San­doz head as new CEO to re­place Kåre Schultz

Kåre Schultz

Te­va has tapped the for­mer CEO of San­doz, Richard Fran­cis, to lead the Is­raeli gener­ics gi­ant, re­plac­ing cur­rent CEO Kåre Schultz.

Fran­cis led San­doz, the gener­ics di­vi­sion of No­var­tis, for five years from 2014 to 2019, leav­ing as No­var­tis be­gan mak­ing plans to spin out the unit. It’s been a chal­leng­ing sev­er­al years for gener­ics com­pa­nies, which have seen sup­ply chains dis­rupt­ed, pres­sure on how much they can charge for drugs, and stock prices in de­cline.

Fran­cis will take over on Jan. 1 as Schultz steps down, Te­va said in a press re­lease Mon­day an­nounc­ing the news. Schultz’s agree­ment with the com­pa­ny had him in the CEO role un­til No­vem­ber of next year, though the com­pa­ny start­ed a search for a new leader about a year ago as the CEO be­gan to con­firm that he in­tend­ed to step down when his em­ploy­ment agree­ment end­ed. Te­va start­ed a search and reached a deal with Fran­cis rel­a­tive­ly quick­ly, and the two sides agreed to make the change soon­er, said Te­va spokesper­son Kel­ley Dougher­ty.

“The board is de­light­ed to have found the ide­al leader for the next phase in Te­va’s ex­cit­ing jour­ney to re­turn to growth and lead­er­ship,” board chair­man Sol Bar­er said in the re­lease.

Schultz led Te­va through a num­ber of chal­lenges, in­clud­ing opi­oids law­suits in the US, gener­ic drug price-fix­ing al­le­ga­tions and busi­ness head­winds across the port­fo­lio of gener­ic and brand-name prod­ucts. The com­pa­ny has re­port­ed a loss in three out of the last four quar­ters.

Fran­cis left San­doz in 2019 for what No­var­tis CEO Vas Narasimhan at the time called “per­son­al rea­sons.” No­var­tis had an­nounced plans a few months pri­or to sell part of San­doz’s US di­vi­sion, and the com­pa­ny was be­gin­ning to sep­a­rate the gener­ics unit’s op­er­a­tions from the par­ent com­pa­ny, ac­cord­ing to Reuters. No­var­tis then an­nounced in Au­gust it would of­fi­cial­ly spin out the busi­ness.

Ed­i­tor’s note: This sto­ry has been up­dat­ed with more back­ground on Schultz’s re­tire­ment. 

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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