(Adds Amylin CEO, analyst comment, updates shares)
By Toni Clarke
BOSTON Aug 26 Amylin Pharmaceuticals Inc
AMLN.O said there have been four deaths among patients with
pancreatitis who took its diabetes drug, Byetta, in addition to
two deaths reported last week by U.S. regulators.
The company said the four cases had not been captured in
the report last week by the Food and Drug Administration, which
said it had received six reports of patients who developed
hemorrhagic or necrotizing pancreatitis that required
hospitalization. Two of those patients died.
Amylin shares, after closing 2 percent lower at $27.24 on
Nasdaq, fell 13 percent in extended trading after the four
additional deaths were announced, but they later pared those
losses to about 8 percent down.
The additional four cases did not involve patients with the
necrotizing form of the disease, which affects 15 percent to 20
percent of patients with inflammation of the pancreas, said
Amylin, which makes Byetta with partner Eli Lilly & Co
Orville Kolterman, Amylin's senior vice president of
research and development, said in an interview the four deaths
were not considered related to the pancreatitis.
"It appears the FDA focused on necrotizing and hemorrhagic
pancreatitis, whereas these other four cases only had
pancreatitis in their history," Kolterman said.
In the necrotizing form of pancreatitis, enzymes digest the
pancreas, which can lead to a hemorrhage.
Even so, he said the company was reporting them "in the
interests of transparency."
Canaccord Adams analyst Adam Cutler said the company was
trying to make a case for why pancreatitis is unlikely to be
caused by Byetta, "yet the FDA is concerned."
Byetta, known chemically as exenatide, was launched in
mid-2005. Amylin and Lilly hope to file for U.S. approval of a
longer-acting version of the drug that needs to be taken just
once a week by mid-2009.
Given the FDA's concerns, Cutler said: "I'm wondering
whether they will have to do longer, larger, safety trials" of
the version that is designed to stay in the body for a full
week. Such a decision could significantly delay the drug
reaching the market.
The prescribing information for Byetta was updated to
include the risk of pancreatitis last October. The FDA cited 30
reports of pancreatitis in Byetta patients and said the drug
was suspected in some cases. Amylin alerted doctors.
One of the four deaths reported on Tuesday was known at
that time, Kolterman said.
Amylin CEO Daniel Bradbury told analysts on a conference
call that the company has since received positive feedback from
"Once physicians understand the context of the data they
are comfortable continuing to prescribe Byetta," he said. "We
haven't seen a major impact on Byetta prescribing."
News of the deaths reported by the FDA on Aug. 18 had sent
Amylin's shares down 13 percent and investors and analysts
questioned the company's failure to issue a news release or
hold a conference call to discuss it.
Now the company says it is providing all information
possible to ensure patients are not confused by what they read
and that future cases of pancreatitis are not necessarily
interpreted as being related to treatment with Byetta.
Kolterman said that of the two deaths reported by the FDA
last week, one was of a male patient who weighed 400 pounds
(181 kg) and had extensive gallstone disease. Gallstone disease
is a common cause of pancreatitis.
The second death was in a patient who had discontinued
Byetta four months before being hospitalized with necrotizing
Among the latest four cases, one died of complications from
surgery after gallbladder removal, the second died from a
relapse of leukemia two and a half months after recovering from
pancreatitis and a third died from intestinal bleeding
following gallbladder removal. Little is known about the fourth
case, Kolterman said.
Lilly's shares, which closed off 1 percent at $47.02 on the
New York Stock Exchange, fell more than 1 percent further in
(Additional reporting by Bill Berkrot in New York and Deena
Beasley in Los Angeles; Editing by Braden Reddall and Andre