* 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 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
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
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
More than 220 million people worldwide suffer from
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,