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6 years ago
UPDATE 4-Lilly, Amylin diabetes drug wins EU recommendation
April 15, 2011 / 5:26 PM / 6 years ago

UPDATE 4-Lilly, Amylin diabetes drug wins EU recommendation

3 Min Read

* 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 shares up nearly 13 pct; Alkermes up 4 pct (Adds analyst comment)

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 news sent shares of Amylin up nearly 13 percent.

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.

"While we believe the EU decision is completely separate from the FDA's decision ... we believe the EU's decision suggests they view Bydureon safe enough for use and the U.S. may likely follow," Deutsche Bank analyst Robyn Karnauskas said in a research note.

Shares in Amylin, which will present on Sunday results from a trial of another experimental drug in patients with lipodystrophy, were up 12.6 percent on Nasdaq at $12.68, while Alkermes was up 4.3 percent at $13.98. Shares of Lilly were up 25 cents at $36 on the New York Stock Exchange. Novo gained slightly.

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. (Additional reporting by Deena Beasley, Editing by Paul Sandle, Phil Berlowitz)

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