* FDA wants more study for preventing osteoporosis
* But no new trials required for treatment
* Shares fall 1.9 percent
(Recasts; adds analyst comment, bylines)
By Lewis Krauskopf and Toni Clarke
NEW YORK/BOSTON, Oct 19 U.S. health regulators
delayed approval of Amgen Inc's (AMGN.O) most important new
drug, the osteoporosis medicine denosumab, the biotechnology
company said on Monday, sending shares down nearly 2 percent.
But, importantly, regulators did not require further
clinical trials before it can complete the review of denosumab
as a treatment for osteoporosis -- the main market for the
"I don't think it's a big deal or particularly surprising,
though there had been a minority of people on Wall Street who
had thought the company might get final approval," said Eric
Schmidt, an analyst at Cowen & Co.
The U.S. Food and Drug Administration is seeking more
information about a program to monitor the drug once on the
market and plans to require a program to manage the medicine's
risks. It requested updated safety data related to the drug.
"We are confident that we can quickly respond to the FDA's
requests for the treatment of post-menopausal osteoporosis
indication and plan to do so in the near term," Roger
Perlmutter, Amgen's executive vice president of research and
development, said in a statement.
The agency requested further clinical trials of the drug
for use in preventing osteoporosis, a bone weakening disease.
However, analysts have been more pessimistic about the
prospects for that use since an advisory panel rejected the
drug for prevention earlier this year.
The company said it expects a separate response from the
agency on potential uses for the drug related to bone loss in
cancer patients -- deflating some hopes for a ruling on those
uses more quickly.
Sanford Bernstein analyst Geoffrey Porges said the drop in
Amgen's shares reflects disappointment that the drug will not
be approved with a broad range of indications as quickly as
investors had hoped. He also noted shares had run up 5 percent
over the past two weeks on anticipation of the FDA's response.
"I don't think this is a serious issue at all," Porges
said. "These are issues that look very doable. It shouldn't
take long to get a risk management program in place that the
FDA is comfortable with."
The FDA requests came in a complete response letter issued
to the company. Such letters are sent when the agency wants
more information before approving products.
Analysts view denosumab, which would have the brand name
Prolia, as a potential blockbuster and the key to jump-starting
growth at the world's biggest biotechnology company. The
twice-a-year injection is expected to compete in an $8 billion
market for osteoporosis treatments.
Denosumab works differently from current medicines by
targeting a protein that activates bone-destroying cells.
Schmidt expects the drug to be approved for osteoporosis by
mid-2010 and is expecting next year's sales of $200 million.
That is lower than the consensus estimate of about $500
million, he said.
"I believe today will be the trigger for bringing those
numbers down," he said.
Amgen expects to receive a separate response for its
application for denosumab for treating and preventing bone loss
in breast and prostate cancer patients.
A panel of outside FDA advisers in August urged the agency
to reject most of the proposed cancer uses and well as
prevention of osteoporosis.
Members of the panel voiced concern about serious
infections seen in some patients and unknown long-term risks.
But they backed the drug for treating osteoporosis and bone
loss from a type of prostate cancer therapy.
Osteoporosis affects an estimated 10 million Americans. The
bone-thinning disease raises the risk of painful and
debilitating spine and hip fractures.
Amgen shares fell 1.9 percent to $60.16 in morning trading
(Reporting by Lewis Krauskopf, Toni Clarke and Lisa
Richwine, editing by Dave Zimmerman)