A top Celgene executive has pinned the blame for the botched ozanimod filing on Receptos. Nadim Ahmed said Celgene’s arm’s-length relationship with the biotech it bought for $7.2 billion three years ago led to a substandard filing and embarrassing refusal-to-file notice.
The FDA hit Celgene with the notice in February after a readthrough of the filing revealed the firm had failed to provide the necessary preclinical and clinical pharmacology information on the multiple sclerosis drug. That delayed approval of a key pipeline prospect with forecast peak sales of around $5 billion a year. And, as such setbacks are rare for well-established drug developers, raised questions about how Celgene came to drop the ball.
Talking to the Financial Times, Ahmed, president of haematology and oncology at Celgene, admitted the company messed up. But he also diverted the blame away from Celgene’s headquarters and toward the ex-Receptos team.
“[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’,” Ahmed said. “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.”
Ahmed framed the dip in standards as a lesson in the need to integrate acquisitions rather than leave them “completely away from the mothership.” Celgene’s ability to learn that lesson will influence its future prospects. Acquired drugs, notably those from the $9 billion buyout of Juno Therapeutics, are already critical to Celgene’s attempts to soften the patent cliff it is heading toward, and will become more so as it executes the “very aggressive” M&A strategy outlined by Ahmed.
Other drugmakers are similarly reliant on bought-in pipeline prospects. With biotechs under pressure to advance drugs as fast as possible, this reliance could lead to more problems for buyers down the line.
“One of the things I’m hearing from the business development people in large companies is that the smaller biotechs have cut corners to try to get drugs to market more quickly,” Ronny Gal, an analyst at Bernstein, said. “They make sure things are 95% certain, but they don’t get to 99%.”