Amylin Shares Decline 43%
After Release of Drug Data
By RHONDA L. RUNDLE
Staff Reporter of THE WALL STREET JOURNAL
Shares of Amylin Pharmaceuticals Inc. plunged 43%
after the San Diego biotechnology company unveiled
disappointing human test results for its lead product
candidate, a diabetes drug called pramlintide.
The shares fell $6.4375 to $8.4375 in Nasdaq Stock
Market trading, following briefings for analysts by senior
company executives over the weekend. The test results
were released late Friday after the close of major
markets.
Analysts said the data weren't sufficient to gain Food
and Drug Administration approval to commercialize the
drug, but they had widely divergent views about
whether pramlintide could prove itself in additional tests
that are under way. There was evidence that some
subgroups of patients might benefit from the drug,
analysts said.
The results were for two separate clinical trials, one in
patients suffering from Type I, or juvenile-onset
diabetes, and the other in the more prevalent form of the
disease known as Type II, or adult-onset diabetes. In
announcing the results last week, Amylin called the
outcome of the Type I study "positive" and the Type II
study "encouraging."
In the Type I study, pramlintide's effects "on lowering
glucose and improving weight and cholesterol profiles
were statistically significant and clinically meaningful,"
Amylin said. In the parallel Type II study, two of the
three pramlintide dose groups achieved statistical
significance after six months, but not after 12 months."
Company officials couldn't be reached for comment
Monday.
Some analysts echoed Amylin's views, but reaction by
other analysts and investors was downbeat. "The results
were mediocre and cast a big cloud on the future of
Amylin," said Sven Borho, an analyst at Mehta & Isaly
in New York. "The problem is that the drug wasn't
efficacious in Type II and had only a small effect in Type
I," said Albert Rauch at Everen Securities Inc. in
Chicago.
Mr. Rauch said that even if further tests show that the
drug helps people with Type I diabetes, that is a
relatively small market. Patients won't be willing to
endure three or four daily pramlintide injections if the
benefit is only marginal, he added.
Other analysts said they would withhold judgment until
Amylin completes four more pramlintide trials next year.
Some analysts were encouraged a year ago when
Johnson & Johnson agreed to continue funding
pramlintide development after getting an early peek at
the test results. The pharmaceutical giant has so far
invested $117 million in Amylin and the pramlintide
program, according to an estimate by Tim Wilson, an
analyst at UBS Securities. Monday, when asked about
the latest test results, a J&J spokesman in New
Brunswick, N.J., said only: "We're going to continue
working with the company toward registration" of the
drug. |
