* Amylin, Lilly await ruling on key diabetes drug Friday
* Report details December inspection of Ohio plant
* Amylin shares fall 2.6 pct
(Adds analyst comment, background)
WASHINGTON, March 12 U.S. regulators found
shortcomings at an Amylin Pharmaceuticals Inc AMLN.O
manufacturing plant during a December inspection, according to a
report released on Friday ahead of an expected decision on the
company's key drug.
The Food and Drug Administration listed 10 observations made
during a visit to an Amylin plant in West Chester, Ohio. Among
them, the agency said "procedures designed to prevent
microbiological contamination of drug products purporting to be
sterile are not established and followed."
Amylin and Eli Lilly and Co (LLY.N) have said they are
expecting the FDA to decide by Friday whether to approve a
once-weekly version of diabetes drug Byetta. The drug is made at
the Ohio facility.
In January, Amylin Chief Executive Daniel Bradbury told
Reuters the FDA had inspected the company's Ohio manufacturing
plant in December and made observations that Amylin believed it
could address by the review deadline for Byetta LAR.
The FDA report notes the inspection findings are
"observations, and do not represent a final agency determination
regarding your compliance."
"We've addressed these findings in previous public statements,
indicating that we believe these observations are addressable,"
Amylin spokeswoman Alice Izzo said in an emailed statement.
Jefferies & Co analyst Thomas Wei said he would caution
against reading into the timing of the posting of the inspection
report as it relates to the decision on the new form of Byetta.
The 10 observations in the inspection are "minor and readily
addressable" Wei said in a research note,
"We remain confident that manufacturing issues are unlikely to
delay approval," Wei said, although he added that other factors
could lead to delays and that Wall Street is split on whether
Amylin will gain full approval on the drug on Friday.
Amylin shares fell 2.6 percent to $20.64 in afternoon trading
on Nasdaq. Shares of Lilly were off 0.1 percent, while shares of
Alkermes Inc (ALKS.O), whose technology was involved in the
development of the once-weekly version, fell 1.8 percent.
Byetta, a twice-daily injection, had sales last year of $797
million. The new version, also known as exenatide LAR, uses the
technology from Alkermes to release the drug at a controlled
In clinical trials, patients treated with once-weekly Byetta
showed a statistically superior reduction in blood sugar than
those taking standard Byetta.
Byetta is also widely used because it leads to weight
reduction, in contrast to many other diabetes treatments that tend
to cause weight gain.
The report was posted on the inspection report on the agency's
(Reporting by Lisa Richwine; additional reporting by Lewis
Krauskopf in New York and Deena Beasley in Los Angeles; Editing by
Dave Zimmerman, Phil Berlowitz)