Amgen Halts Pancreatic Cancer Trial After Drug Failure

Amgen Inc. (AMGN), the world's largest
biotechnology company, stopped a late-stage study of an
experimental pancreatic cancer drug, saying the medicine was
unlikely to help patients.

An analysis by an independent monitoring committee
concluded that the therapy, ganitumab, or AMG 479, probably
wouldn't improve survival of patients with metastatic pancreatic
cancer, Thousand Oaks, California-based Amgen said today in a
statement. Amgen and partner Takeda Pharmaceutical Co. (4502), based in
Tokyo, were testing ganitumab with the chemotherapy gemcitabine
against gemcitabine alone.

Ganitumab, in the third and final round of human trials
typically required for U.S. regulatory approval, targeted the
type 1 insulin-like growth factor receptor, which regulates cell
growth. Several drugmakers have seen failures of cancer drugs
targeting the IGF receptor, including Pfizer Inc.'s figitumumab,
Sanofi's AVE 1642 and Roche Holding AG's RG1507.

"This is yet another reason why we believe Amgen needs to
be more prudent with RD expense and raise its hurdle for go/no-
go decisions," Michael Yee, an analyst at RBC Capital Markets,
wrote today in a note to clients. "Once again, this shows why
predicting Phase III from small Phase II studies in solid tumors
is risky, particularly in difficult-to-treat and aggressive
cancers such as pancreatic where failure is common."

About 44,000 new cases of pancreatic cancer will be
diagnosed in the U.S. this year and the disease will kill about
37,390 patients, according to the National Cancer Institute.

Separate Study

Amgen also is canceling a separate Phase 2 trial for
patients with locally advanced pancreatic cancer, the company
said in the statement.

In light of the study's failure, Amgen is now reviewing its
other trials testing the drug including colorectal and small-
cell lung cancer, Christine Regan, a spokeswoman, said in an e-
mail.

"These disappointing results underscore the difficulty of
treating pancreatic cancer, which remains a major unmet medical
need," Sean Harper, executive vice president of research and
development at Amgen, said in the statement.

Amgen fell less than 1 percent to $81.03 in extended
trading after the close in New York.

To contact the reporter on this story:
Ryan Flinn in San Francisco at
rflinn@bloomberg.net

To contact the editor responsible for this story:
Reg Gale at
rgale5@bloomberg.net