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.
“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.
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