How Will FDA Ruling Affect Eli Lilly's Effient?

Oct.19.08 | About: Eli Lilly (LLY)

I don't think Eli Lilly (NYSE:LLY) will be running any more "Coming Soon" ads--like the one posted here for its late-stage experimental bloodthinner Effient--for drugs that haven't been approved yet by the Food and Drug Administration.

Given the unpredictable nature of the agency and its post-Vioxx safety consciousness, biopharmaceutical companies just can't count their chickens before they hatch.

Late Thursday "The Pink Sheet" (a publication that follows the drug industry, not to be confused with stocks that trade on the pink sheets or over the counter) broke the story that the FDA is going to kick Effient to at least one, possibly two, advisory committees early next year.

The agency had put Effient, also known by the scientific/generic name prasugrel, on a fast track toward potential approval, but has twice delayed making a decision on the drug. Advisory committees are outside panels of "experts" that review products for the FDA, usually when there are safety and/or efficacy concerns, and then make non-binding recommendations to the FDA about what it should do.

Tests have shown Effient works better than the blockbuster bloodthinner Plavix from Bristol-Myers Squibb (NYSE:BMY) and Sanofi-Aventis (NYSE:SNY), but in doing so it may cause some patients to bleed too much.

Lilly put out a press release on the report saying the FDA hasn't notified the company about any adcom meeting(s) yet. CEO John Lechleiter as late as last Thursday in an interview with CNBC's David Faber on "Squawk on the Street" from the Business Council's meeting in South Carolina said he couldn't give any timing on an FDA decision.

Analysts are all over this latest development. JPMorgan's Chris Schott, who recently downgraded LLY to "Underweight" (a euphemism for "Sell"), wrote in a research note to clients Friday morning, "In the event there were a (advisory committee) panel, we would expect at least a 4-6 month delay until an FDA decision." JPM did some work for ImClone Systems (OTCPK:IMCL) on the LLY deal.

This gives SNY and BMY a little more breathing room for Plavix. And that's prompting Deutsche Bank's Barbara Ryan to reiterate her "Buy" rating on BMY. She is reminding clients, "Each $100 million in incremental Plavix sales add up to $0.02 (two cents) to our BMY annual EPS estimates." DB wants to do investment banking for BMY, makes a market in the stock and owns at least one percent of the shares.

Big pharma earnings season gets into full swing next week with Schering-Plough (SGP) and Pfizer (NYSE:PFE) on Tuesday, Merck (NYSE:MRK) and Wyeth (WYE) on Wednesday, with BMY and and LLY batting cleanup on Thursday. Maybe investors will get some clarity then on how "soon" Effient is coming.