UPDATE 3-Lilly, Amylin diabetes drug wins EU recommendation

Fri Apr 15, 2011 8:45am EDT

* Bydureon recommended for type-2 diabetes in adults

* Eli Lilly, Amylin and Alkermes are partners on drug

* Once-weekly injection a rival for Novo's daily Victoza

* Amylin, Alkermes higher in pre-market; Novo off 0.5 pct

(Adds analyst comment, shares)

By Ben Hirschler

LONDON, April 15 (Reuters) - An experimental diabetes medicine from Eli Lilly (LLY.N) and Amylin Pharmaceuticals (AMLN.O), that patients need to inject only once a week, has been recommended for approval by European regulators.

The European Medicines Agency said on Friday that Bydureon -- a longer-acting version of Byetta, another drug sold by Lilly and Amylin -- was suitable for the treatment of type-2 diabetes in adults.

Both drugs compete with Novo Nordisk's (NOVOb.CO) Victoza, which is injected daily.

Recommendations from the agency's expert committee on new drugs are normally endorsed by the European Commission within a couple of months.

Deutsche Bank analyst Tim Race said the green light in Europe came as a slight surprise, given the delays faced by Bydureon in the United States, adding the competition could temper some more bullish expectations for Novo's Victoza.

"Although Bydureon is not as efficacious as Victoza, its once-a-week dosing -- versus Victoza's daily need for injections -- will be attractive to some patients," he said in a note.

Bydureon has been touted as a key driver for Lilly, Amylin and partner Alkermes (ALKS.O), but the product has faced repeated delays in the all-important U.S. market. Last October, U.S. regulators asked for more data on potential heart risks before approving the medicine.

Shares in Amylin traded higher in pre-market dealings on Nasdaq at $12.75, up from Thursday's close of $11.26, while Alkermes was at $13.55 against $13.41. Novo slipped 0.5 percent.

Bydureon, Byetta and Victoza belong to a new class of therapies that not only control blood sugar levels, but can prompt weight loss, a benefit because obesity is a leading cause of diabetes.

More than 220 million people worldwide suffer from diabetes.

Bydureon is designed to be given in combination with metformin, a sulfonylurea, a thiazolidinedione, metformin plus a sulfonylurea or metformin plus a thiazolidinedione. (Editing by Paul Sandle)

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