* FDA requests finalization of product labeling
* FDA does not ask for additional trials
* Amylin shares rise 13 pct in afternoon trading
* Alkermes shares rise 12 pct
(Adds analyst comment, updates share price)
By Toni Clarke
BOSTON, March 15 Amylin Pharmaceuticals Inc
AMLN.O said U.S. health regulators did not immediately
approve a once-weekly form of its diabetes drug Byetta but did
not ask for lengthy new clinical trials -- a relief to
investors who pushed the company's stock up over 13 percent.
In a letter to Amylin and partner Eli Lilly and Co (LLY.N),
the U.S. Food and Drug Administration requested finalization of
information to be included in the drug's label, and a risk
evaluation and mitigation strategy, Amylin said on Monday.
"This development is positive in that it most likely
removes the possibility of a lengthy delay beyond 2010," Cory
Kasimov, an analyst at J.P. Morgan, said in a research report.
The agency also requested clarification of Amylin's
manufacturing processes, but it did not make requests related
to observations from a pre-approval inspection at an Ohio
U.S. regulators found shortcomings at the plant during an
inspection in December, but Amylin said all of those
observations have been addressed. [ID:nN12246564]
The new drug, with a proposed name of Bydureon, is a
once-weekly version of Byetta, which is given twice daily by
injection and which had sales last year of $797 million.
Byetta, whose chemical name is exenatide, is used to treat
type II diabetes -- the more common form of the disease that is
closely linked to obesity. Bydureon, known chemically as
exenatide LAR, uses technology from Alkermes Inc (ALKS.O) to
release the drug at a controlled rate.
Shares of Alkermes rose $1.54 or 12.6 percent to $13.75 in
afternoon trading on Nasdaq.
In January, the FDA approved a similar drug -- Novo Nordisk
A/S's (NOVOb.CO) Victoza. Both drugs belong to the GLP-1 class
of drugs that stimulate insulin production to regulate blood
The FDA approval of Victoza, a once-daily injection,
included a boxed warning for the risk of thyroid cancer.
The company declined on a conference call to give details
of what it expects to see in the final label, but J.P. Morgan's
Kasimov said he sees a low probability of a label that avoids a
cancer risk warning.
"We still believe there's a relatively high probability of
a Victoza-like label," he said. "Differentiation may occur on
the breadth of the indicated target population."
Byetta has been associated with a risk of pancreatitis, a
potentially fatal inflammation of the pancreas.
Amylin's shares rose $2.72 or 13.4 percent to $22.98 on
Nasdaq. Shares of much larger partner Eli Lilly were off 9
cents or 0.3 percent at $35.84.
(Additional reporting by Esha Dey; Editing by Gerald E.
McCormick and John Wallace)