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]will pull off what some analysts think would be an upset today. No one, that I know of, thinks that a clean, full-out Food and Drug Administration approval of the company's bloodthinner Effient is a slam dunk.
Today, September 26th, is the day the FDA is expected to make a decision on the drug. The agency could approve it outright, approve it with conditions/limitations, delay making a decision--again--and order more tests, or reject the pill. I think I covered all of the possible scenarios there. Effient would compete with Plavix from Bristol-Myers Squibb [BMY
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]and Sanofi-Aventis[SNY
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]. Plavix is an $8 billion-a-year drug, the second-best selling pharmaceutical in the world behind Pfizer's [PFE
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]Lipitor.
Analyst handicapping is all over the place:
- Leerink Swann's Seamus Fernandez: "We believe chances for FDA approval or a modest delay are high."
- Miller Tabak's Les Funtleyder: "We anticipate some form of approval for Prasugrel (the generic, scientific name for Effient), but believe the label will
- be narrow." (That means he thinks there will be restrictions on its use.)
- BMO Capital Markets' Bert Hazlett: "FDA action on prasugrel may provide a catalyst, though it remains high risk."
- JPMorgan's Chris Schott: "We expect a roughly one-year delay."
- Bernstein's Dr. Tim Anderson: "Industry contacts uniformly suggest a full approval will occur."
- Deutsche Bank's Barbara Ryan: "In the current regulatory environment...a negative response could be forthcoming, particularly focused on the uncertainties around the increased risk of major bleeding." She's referring to a big study that showed Effient works better than Plavix, but that in some cases it may work so well that it thins the blood too much, especially in older patients who don't weigh much.
See what I mean, though? The varying opinions are, perhaps, emblematic of the extremely unpredictable FDA these days.
Decisions like this one typically come down late in the day, even on a Friday. And in today's news cycle, frankly, it's gonna have a difficult time breaking through the headline threshold against the backdrop of the financial bailout.
Disclosures: Leerink Swann may trade in shares of LLY. Deutsche Bank makes a market in LLY, owns at least one percent of the shares and has done and wants to do more investment banking for the company.
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