Top Cel­gene ex­ec pins the blame for ozan­i­mod fi­as­co on the Re­cep­tos team — ac­quired 3 years ago

Cel­gene’s top ex­ecs have been reel­ing for months, stag­gered by the FDA’s de­ci­sion to kick back their ap­pli­ca­tion on ozan­i­mod, the big drug in the late-stage pipeline that is bad­ly need­ed as the com­pa­ny looks to build new rev­enue and lessen its de­pen­dence on Revlim­id price hikes. And now one of the lead­ers in­volved in the em­bar­rass­ing refuse-to-file set­back with ozan­i­mod isn’t just agree­ing that their ap­pli­ca­tion was in­ad­e­quate, he’s point­ing fin­gers di­rect­ly at the team they brought in when they ac­quired the drug with their $7.2 bil­lion Re­cep­tos buy­out.

Nadim Ahmed

“I think that 99% of folk at Cel­gene wouldn’t have sub­mit­ted, but we had Re­cep­tos out on the West Coast and, for what­ev­er rea­son, the de­ci­sion was made to sub­mit,” Cel­gene’s head of hema­tol­ogy and on­col­o­gy Nadim Ahmed told David Crow at the Fi­nan­cial Times. “We learned a les­son of hu­mil­i­ty and that when you do an ac­qui­si­tion it’s bet­ter to be more in­te­grat­ed rather than be com­plete­ly away from the moth­er ship.”

Cel­gene — helmed by a cur­rent ex-Ma­rine, who got the job from an­oth­er ex-Ma­rine — has been known for a for­ward-think­ing, can-do ap­proach to bio­phar­ma. Pre­sum­ably that ex­tends to the way it in­te­grates the com­pa­nies it buys. The Re­cep­tos team, though, ev­i­dent­ly nev­er mea­sured up to Cel­gene stan­dards, and reg­u­la­tors ex­pressed amaze­ment that the Cel­gene NDA was un­ac­cept­able.

Said Ahmed:

[The FDA] kin­da said ‘what hap­pened guys, this isn’t what we usu­al­ly ex­pect from Cel­gene?’ And we had to say, you know, ‘mea cul­pa it’s on us’.

Or them.

Ron­ny Gal

Com­plet­ing the blame-it-on-Re­cep­tos ap­proach, Ron­ny Gal at Bern­stein not­ed that lit­tle biotechs may cut cor­ners that a big cap com­pa­ny like Cel­gene wouldn’t dream of. And he cau­tioned that any ac­quir­er has to keep that in mind dur­ing the M&A process.

Of course, Cel­gene has had three years to fix any­thing that was wrong at Re­cep­tos. So some­body on the in­side al­so fell short. But we’re not hear­ing about that to­day.

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Mark Iwicki, Kala Pharmaceuticals CEO (Merus)

Al­con takes a crack at multi­bil­lion-dol­lar dry eye mar­ket, picks up 2 drugs from Langer spin­out

Kala Pharmaceuticals may have never come close to the blockbuster dreams it had for its dry eye disease treatment, but Alcon wants to see if it can take the drug further.

After giving commercialization its best shot over the past few years, Kala decided the marketing game is not for it after all. Instead, it will sell both of its commercial eye drop products — Eysuvis for dry eye disease, and Inveltys for post-operative inflammation and pain following ocular surgery — to Alcon for $60 million in cash, plus an undisclosed amount of milestones.

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Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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