Mixed news for Lilly drug pipeline-WEB ONLY

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Eli Lilly and Co. got good news and bad news Friday.

The same day U.S. regulators recommended Lilly’s blood thinner prasugrel for market approval, one of the Indianapolis pharmaceutical company’s partners reported poor clinical results for one of its most promising drugs.

Canada-based BioMS Medical Corp. said its lead drug for treating relapse remitting multiple sclerosis failed to meet a main goal in a mid-stage study and did not prevent symptoms from returning in patients.

Shares in BioMS fell 50 percent on the news.

Yet BioMS and Lilly are pushing forward with the drug, dirucotide, in two late-stage trials aimed at reversing the progress of a different kind of multiple sclerosis, called secondary progressive multiple sclerosis.

The mid-stage study did show that dirucotide slowed progression of multiple sclerosis.

“The results are more positive than negative,” analyst Douglas Loe told Reuters. “The aspects by which the drug did perform well in this trial are those that are germane to performance in its pivotal secondary progressive MS trial, which is a separate clinical program.”

BioMS and Lilly hope dirucotide will be approved in 2011 or 2012. Analysts say the drug could achieve $5 billion in annual sales if it proves broadly effective against multiple sclerosis.

Also Friday, Food and Drug Administration staff said that improved effectiveness of Lilly’s blood thinner prasugrel, compared with the current leading blood thinner Plavix, “seems beyond question.” Plavix, made by Bristol-Myers Squibb and Sanofi-Aventis, has more than $8 billion in annual sales.

The FDA has twice delayed its decision on prasugrel since Lilly and its development partner Daiichi Sankyo Ltd. submitted the drug in January 2008. The drug’s approval is considered key for Lilly’s financial outlook, as the patent on its best-selling drug, the anti-psychotic Zyprexa, is due to expire in two years.

Lilly hopes some of its up-and-coming drugs, such as the diabetic medicine Byetta, can help offset lost Zyprexa revenue once cheaper generic copies of that drug hit the market.

Lilly markets Byetta with San Diego-based Amylin Pharmaceuticals Inc. However, two shareholders are trying to gain control of Amylin’s board.

Eastbourne Capital Management and Carl Icahn each have nominated slates of directors in an attempt to wrest control of the company from current management.

Amylin shares have plunged more than 60 percent over the last 12 months as Wall Street remains concerned over sales of the company’s diabetes drug Byetta and the potential for new treatments in a competitive market. Amylin was trading at about $11.50 this morning.

In November, Eastbourne said it was talking with Amylin about options including “a possible acquisition by a third part,” according to Bloomberg News.

The most logical buyer in such an acquisition would be Lilly, “because they already partnered with Amylin” on Byetta, analyst Adam Cutler told the news service in a Jan. 29 interview.

“The Lilly relationship complicates the purchase for anybody other than Lilly,” he said.

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