Drug Safety Updates For Elan, Biogen, Amylin & Lilly

Byetta Needle
Byetta Needle

After the closing bell Monday, Eli Lilly and Amylin Pharmaceuticals announced that they're going to hold a conference call for analysts and investors about their diabetes drug Byetta.

Last week, the Food and Drug Administration revealed that six patients on the drug had to be hospitalized with serious forms of pancreatitis and that two of them died. The companies said the numbers are really no different than what's seen in the general population of people with pancreatitis.

But since the FDA warning came out, LLY shares have fallen three-and-a-half percent and AMLN shares have dropped 18 percent. Now you know why they're doing a conference call.

Credit Suisse big pharma analyst Catherine Arnold put out a research note to clients Tuesday morning titled, "Byetta Call Uncertainty May Cause Apprehension." She's referring to whether the conference call commentary will hurt sales of the twice-a-day injectable Byetta and the timeline for the filing of FDA approval of a once-a-week version of Byetta.

Arnold writes, "We suspect we will get little information on the (once-a-week Byetta) filing and the call will focus more on Byetta, with the most important points being the monotherapy indication, label revisions on pancreatitis safety concerns and whether a Risk Evaluation and Management plan will be implemented and whether that is restrictive to use."

The monotherapy indication means the use of Byetta alone, not in combination with other diabetes drugs. Arnold says an FDA decision on that is expected by the end of next month. Credit Suisse has done and wants to do more investment banking for LLY.

Meantime, yesterday the FDA announced that it knows of no new American cases of PML, the rare, potentially fatal brain disorder among multiple sclerosis patients taking Tysabri from Biogen Idec and Elan.

The shares rallied on that news and continue to trade higher this morning. But the agency also said that it is working with the companies to update the drug label about PML occuring in patients taking Tysabri alone, and not just in combination with other MS drugs. That's because two people in Europe on monotherapy got PML. The drug had been taken off the American market, but later brought back under tight restrictions, after a few patients on combo therapy developed PML.

In a research note to clients this morning, JPMorgan Chase biotech analyst Geoffrey Meacham reports that researchers gave an update on the two European cases at a scientific conference in Madrid today. One of the patients is reportedly "out of risk" and the second patient, who had a more severe case, is "in the early recovery phase."

Meacham writes, "In our view, today's announcement is positive and continues to point to PML as a side-effect that can potentially be managed, rather than the near certainty of death or severe neurological impairment that was previously thought." JPM makes a market in BIIB, has banked the company and wants to do it again.

By the way, in a timely mention, during her speech at the Democratic National Convention last night, Michelle Obama talked at great length about her late father's battle with MS. One has to wonder, if she takes up residence in the White House, what influence she might try to have in the fight against the disease.

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