Troubles With Lilly's Effient Empire

Tree huggers (just a colloquialism, not a dig) will be glad to know that biopharmaceutical companies submit their Food and Drug Administration filings for drug approval electronically these days.

Dr. Tony Ware, the head of Eli Lilly's (LLY) cardiovascular unit, says his people tell him that if you printed out all of the data the drugmaker submitted on CDs, DVDs and in PDFs for its bloodthinner Effient the paperwork would stack as high as the Empire State Building. That's 1,453 feet of documents. Dr. Ware says it's the company's biggest-ever submission.

So, given how much stuff the agency has to go over, perhaps it should not have come as much of a surprise when LLY announced late Monday that the FDA is putting off a decision on Effient, also known as prasugrel, for another three months. Dr. Tim Anderson at Sanford C. Bernstein writes in a research note to clients that the delay is evidence of "recent comments by senior FDA staff that the agency is essentially under-funded and under-resourced to do all that it needs to do."

The FDA had given Effient what's called "Priority Review" when it turned in the application for approval late last year. That is supposed to cut in half the standard one-year review time. But now the agency says it needs as much as another few months. And that's a moving target. The drug could still get sent to an advisory committee--an outside panel of experts--in August for an opinion on whether Effient should be approved or not.

A huge study showed Effient worked better than the world's top-selling bloodthinner Plavix from Bristol-Myers Squibb (BMY) and Sanofi Aventis (SNY). Dr. Ware says for every 1,000 patients who took Effient, nearly two dozen heart attacks were prevented versus those who took Plavix. But the drug may thin some patients' blood too much.

There was a handful of reports of excessive bleeding. But as Dr. Ware told me over the phone yesterday morning, "Twenty-three heart attacks were prevented at the expense of six major bleeds. We think that's an exciting clinical benefit." He also made a point of communicating that LLY is not touching its financial guidance for this year in the wake of the FDA setback. Nonetheless, LLY hit another new multi-year low yesterday morning, SNY rallied, but interestingly BMY did not at first, but turned around in the late morning.

Dr. Ware wouldn't divulge what the FDA holdup is about, but many analysts suspect it has to do with the bleeding issue and the identification of specific groups of patients the drug might be approved to treat. Dr. Ware would only say that the company, so far, has answered more than 200 wide-ranging questions from the agency.

Credit Suisse analyst Catherine Arnold has an Outperform (Buy) rating on LLY, but she's telling clients to expect the stock "to remain range-bound until the final verdict on prasugrel is delivered in September." CS has banked LLY and wants to do it again soon.

The new potential FDA decision date for Effient is now September 26th. As I've blogged before, I think the agency could also kick back the proposed commercial name. Effient may be too close to efficient. Or on the flip side, effluent. And that ain't good.