Amylin Insists Byetta Doesn't Cause Cancer; Wall Street Doesn't Seem So Sure
Amylin CEO Daniel Bradbury may be wishing that Novo Nordisk’s failed competitor to its diabetes drug Byetta had actually been approved by the FDA. Had Novo’s liraglutide passed muster, no one would have gotten the jitters over whether Byetta gives you cancer or not.
At Amylin’s conference call a couple of days ago, the cancer issue was front and center. Bradbury was no doubt concerned that since Novo’s liraglutide failure his stock has been down in the $9 to $10 range, from a high of $13.47 last March, on worries that the same cancer signal might pop up in Byetta. So Bradbury and R&D chief Orville Kolterman tried to set the stage that there was no cancer signal among the Byetta data:
Orville Kolterman: BYETTA has no preclinical signals of cancer, but instead had established a well documented safety profile. BYETTA has been used in more than 1 million patients with over 7 million prescriptions written since introduction to the market. BYETTA and liraglutide are distinct molecules with significant differences in structure and metabolism.
So … case closed? Not quite. Some cancer was seen in the rat tests but not in the primate tests, the execs said. Then it was the turn of the analysts to ask questions. Every single one of them asked about cancer. It started like this:
Thomas Wei - Piper Jaffray: A couple of question on the thyroid cancer front … have you actually had a chance to talk to the FDA about whether or not you have sufficient data for filling? It sounds like you don’t plan to wait for feedback from the FDA before filling the application and I’d like to understand why that might be.
CEO Daniel Bradbury: Thanks for the question. … we’re talking about rat data here and there has been no maternally thyroid cancer seen in the human studies, with exenatide once weekly state.
With regards to your question regarding consultation with the FDA, we’ve had continuous consultation with the FDA … and we’ve received no indication from the agency at this point that there’s any additional toxicology data are required for our submission.
Wei wasn’t satisfied with that answer (emphasis added):
Thomas Wei - Piper Jaffray: I guess just to clarify, have you actually talked to them since the Liraglutide panel and have you specifically asked about their comments on long acting formulation seeming to have a different thyroid simulation profile and you might need to do for LAR?
Orville Kolterman: Thomas, we’ve had no response from the agency or no comment from the agency since the Liraglutide panel in that regard.
Following him there came cancer questions from Matt Osborne of Lazard Capital Markets, Cory Kasimov of J.P. Morgan, Tom Russo of Robert W. Baird, Craig Gordon of Frontside Research, and Jim Birchenough of Barclays Capital.
Once they were done, there was no more time left and Bradbury closed the call.
- See previous coverage of Amylin:
- Amylin Q1: “Icahn Doesn’t Know Who Our CEO Is”
- In War for Amylin, Icahn and Eastbourne Win a Battle: “Poison Pill” Revoked
- Amylin Founder Resigns, Suggests Chairman Follow; Icahn and Eastbourne Likely Delighted
- Inside Amylin’s Anti-Icahn Suicide Pact
- Amylin Battle Heats Up as Eastbourne Capital Touts Rival Directors’ Slate to Icahn’s
- Icahn Moves on Amylin; Will Lilly Step Up?
- Behind the Byetta Crisis: Is This Drug Really All That and a Bag of (Fat-Free) Chips?
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.
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