Blame the ozan­i­mod fi­as­co on the Re­cep­tos team? Just wait a sec, says ex-CEO, who sold the com­pa­ny to Cel­gene for $7.2B

Ear­li­er to­day we picked up some crit­i­cal re­marks that a se­nior Cel­gene ex­ec had to say about the team at Re­cep­tos, the sub­sidiary or­ga­ni­za­tion which hand­ed in an ap­pli­ca­tion for the would-be block­buster ozan­i­mod on­ly to have FDA reg­u­la­tors kick it right back with an em­bar­rass­ing refuse-to-file no­tice. And it didn’t play well with the CEO who sold the com­pa­ny to Cel­gene for $7.2 bil­lion.

Fa­heem Has­nain

“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.”

Now, wait a sec, says ex-Re­cep­tos CEO Fa­heem Has­nain. There’s more to the sto­ry than that. And the moth­er ship was in di­rect com­mand of the sit­u­a­tion in San Diego, in­clud­ing the crit­i­cal con­tacts with the FDA reg­u­la­tors who wound up rolling their eyes at the ap­pli­ca­tion.

“It’s im­por­tant to know that Cel­gene had on-site con­trol and over­sight for two-and-a-half years be­fore this fil­ing took place,” Has­nain tells me in a fol­low-up. And just maybe it was the Cel­gene crew that left out a few crit­i­cal de­tails in the run-up to the fil­ing.

“Reg­u­lar en­gage­ment and com­mu­ni­ca­tions with the FDA is crit­i­cal to fil­ing,” Has­nain adds. “A refuse-to-file is a dif­fi­cult thing to achieve, and it ap­pears there was some en­gage­ment (with the FDA) that ap­pears to be miss­ing.”

At the time of the buy-out, he adds, the biotech had mapped out the rest of the de­vel­op­ment and reg­u­la­to­ry plans, with the rest of the phar­ma­col­o­gy stud­ies that need­ed to be done in a time­ly fash­ion. 

“We’re kind of dis­ap­point­ed with some of the com­ments that have been made,” says Has­nain. “It’s un­for­tu­nate that this kind of fin­ger point­ing is go­ing on.”

Cel­gene’s top ex­ecs have every rea­son to be red-faced over the in­ci­dent. The refuse-to-file came on top of a ma­jor late-stage im­plo­sion at the big biotech, and the fi­as­co over the ap­pli­ca­tion made the top ex­ecs look vir­tu­al­ly dys­func­tion­al. That hap­less rep lies in stark con­trast to the can-do ef­fi­cien­cy and clean ex­e­cu­tion that marked the Bob Hug­in era.

I asked Cel­gene if they want­ed to re­spond to Has­nain’s re­marks, but no one re­spond­ed.

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.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

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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Bay­er starts work on $43M+ ex­pan­sion of OTC man­u­fac­tur­ing site in Penn­syl­va­nia

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.