Study Downplays Risk Of Amylin's Byetta, But Concerns Remain
March 13 2009 - 1:18PM
Dow Jones News
Amylin Pharmaceuticals Inc.'s (AMLN) stock is getting a boost
Friday after a published analysis that downplays the pancreatic
risks of its diabetes drug Byetta, but investors will likely need
more insight before regaining confidence in the battered drug
maker.
Shares of the San Diego-based Amylin recently rose 7.4% to
$10.80, but it remains down 70% from its August high of $34.80.
The data, found in a journal called Current Medical Research and
Opinion, provide some reassurance to investors concerned about
looming label revisions and slowing drug sales, both of which were
prompted by reports about deaths of patients on Byetta.
Amylin has previously alluded to the findings of the analysis,
which was funded by the company and its marketing partner Eli Lilly
& Co. (LLY). It uses an insurance company database to show that
neither Byetta nor Merck & Co.'s (MRK) Januvia increased the
risk for pancreatitis, an inflammation of the pancreas.
In August, news about the deaths led the FDA to start working
with the companies to add stronger warnings about severe
pancreatitis to the drug's label. The label revision is expected
soon, but its delay also has put off FDA approval for Byetta's use
as a monotherapy.
Because diabetes patients have a higher incidence of
pancreatitis than the general population, Amylin has stressed that
Byetta's use doesn't statistically increase the likelihood of
pancreatitis complications or death.
The pending label changes show that FDA seems to differ in that
opinion.
The regulatory uncertainty has raised worries that the FDA will
want more studies on a longer-acting version of Byetta, in
development with Alkermes Inc. (ALKS) and expected to launch in
2010.
The launch and timing of that new drug, which Lazard Capital
Markets expects to have $1.8 billion in sales as soon as 2012, is
seen as vital to the unprofitable Amylin as sales growth of Byetta
rapidly decelerate.
U.S. sales of Byetta grew almost 50% in 2007 to $636 million,
but they only rose 6% in 2008 to $679 million.
Those sales could come under greater pressure in mid-2009 when
Novo Nordisk A/S (NVO) is expected to launch liraglutide, which
works in a similar manner but is taken daily, compared to Byetta's
twice a day.
-Thomas Gryta; Dow Jones Newswires; 201-938-2053;
thomas.gryta@dowjones.com