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.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Pfiz­er, Sarep­ta and two oth­ers sug­gest Duchenne drug safe­ty is­sues tied to "class ef­fect"

Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why.

The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Martin Shkreli (Dennis Van Tine/MediaPunch/IPX)

In­fa­mous biotech ex­ec Mar­tin Shkre­li gets out of prison, hits the street

Martin Shkreli, the infamous biotech CEO who made headlines for his jeering assault on a legion of critics in and out of Congress, is back on the streets after 4 years inside a federal penitentiary.

Shkreli’s attorney put out a statement Wednesday afternoon saying that the “pharma bro” had been transferred to a halfway house in New York with a few more months to go under federal custody, slated to end September 14. Attorney Benjamin Brafman acknowledged the release and vowed that he and Shkreli are keeping quiet.

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De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

Lina Khan, FTC chair (Saul Loeb/Pool via AP)

New FTC com­mis­sion­er could turn the tide for an in­ves­ti­ga­tion in­to PBMs

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

Patty Murray (D-WA) (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.