At a time when the executive crew at Celgene has rattled investors with a series of setbacks on clinical development, the big biotech is reorganizing its leadership on drug development and turning to a former Merck R&D star to lead the way out of the wilderness.
Alise Reicin, who played a major role in the big development campaign for Merck’s Keytruda, is being placed in charge of the critical mid- to late-stage development work at Celgene, where it’s been experiencing its biggest problems.
Reicin spent the last 3 years as a senior VP at the German Merck’s biotech arm, EMD Serono, where she helped lead the charge on Bavencio (avelumab), their PD-L1 partnered with Pfizer.
“Led by Alise, our clinical development organization will be structured to more completely align with our strategy and mission to discover, develop and commercialize innovative therapies for patients with unmet need,” says CEO Mark Alles in a statement. He noted that Reicin would be in charge of project leadership and management, leaving Rupert Vessey to head up early research and development.
Left unsaid is the tacit mess that’s been afflicting Celgene’s late-stage development work. Their program for ozanimod, picked up in a $7.8 billion deal to buy Receptos, led straight to an embarrassing refuse-to-file notice from the FDA, which wanted to wait for some additional studies to be complete. Celgene has promised to get that done and back to the FDA in Q1 2019, but analysts have been buzzing about the potential for further embarrassing delays.
The problems with ozanimod, coming right after the Phase III failure of mongersen last fall — the subject of a rich $710 million deal — rankled investors and analysts, who were used to seeing a crisp performance under the old team led by Bob Hugin, including insiders like Tom Daniel and George Golumbeski, who eventually followed Hugin — now running for the US Senate — out the exit.
Still playing out as well, Celgene has to integrate Juno’s CAR-T operations into the company after Alles’ $9 billion buyout. And rumors are starting to circulate in industry circles that that process has also been less than ideal.
Reicin also played a role in the development of Vioxx at Merck, yanked from the market in 2004 after evidence mounted that the pain drug caused a spike in risk for heart attacks. She featured in The New York Times coverage, overriding a physician’s conclusion that one of their trial patients had died of a heart attack.
”I think this should be called an unknown cause of death,” Reicin replied, according to the Times report. Soon after, she added, “I would prefer unknown cause of death so we don’t raise concerns.”
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