U.S. regulators are only seeking to clarify information about
manufacturing and risk labels for the long-acting version of
diabetes drug Byetta being developed by Amylin Pharmaceuticals Inc.
(AMLN) with partners Eli Lilly & Co. (LLY) and Alkermes Inc.
(ALKS).
Amylin shares were down 1.3% at $20 premarket after closing
Friday down 4.4%. Neither Lilly nor Alkermes were trading
premarket.
The Food and Drug Administration's response to the application
for the Bydureon, which is a once-weekly version of Byetta, didn't
request any new clinical trials.
Orville G. Kolterman, an Amylin research and development
executive, said the response letter gives the companies "a clear
path forward" to bringing the therapy to patients. He said they are
working diligently on submitting a response to the FDA in the next
few weeks.
Byetta is injected twice daily to reduce blood sugar; Bydureon
needs to be injected only once a week. Byetta has been associated
with pancreatitis and kidney function problems in the past.
In its response letter, the FDA requested finalization of the
product labeling with accompanying risk evaluation and mitigation
strategy and clarification of existing manufacturing processes.
Expectations for the drug, also known as Byetta LAR, are high.
Credit Suisse analyst Catherine Arnold recently projected $2.1
billion in sales for the drug in 2015, and Barclays analyst Jim
Birchenough sees sales eventually exceeding $3 billion in the U.S.
alone.
There was once high hopes for the sales trajectory of Byetta,
which proved to be disappointing following its 2005 launch, and
investors have been looking forward to the new version ever since.
Amylin has never turned a profit, and the stock has been weighed
down from regulatory woes, a problem some see continuing.
As diabetes in the U.S. reaches epidemic levels, the market for
diabetes-testing products is growing nearly as fast as the disease
itself. But competition has heightened, too. According to the
Centers for Disease Control, about a third of the U.S. population
had diabetes in 2008, the most recent year data were available.
-By Joan E. Solsman, Dow Jones Newswires; 212-416-2291;
joan.solsman@dowjones.com
(Thomas Gryta contributed to this story)
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