Amgen's Vectibix Misses Survival Goal,But Sales Could Benefit
By Thomas Gryta, Of DOW JONES NEWSWIRES
NEW YORK -(Dow Jones)- Amgen Inc.'s (AMGN) cancer drug Vectibix failed to
improve overall survival in a study as initial treatment for advanced colorectal
cancer patients, but some believe the data could help boost sales.
Despite missing the secondary goal of the trial, some believe the data could
support earlier use and wider approval of the drug in colorectal cancer -- where
it competes against Erbitux, sold by Eli Lilly & Co. (LLY) and Bristol-Myers
Squibb Co (BMY). The latest results show increased survival of more than four
months in patients without a specific gene mutation, but the data didn't meet
statistical significance, meaning the results could be due to chance.
The study had already met its primary goal over the summer of delaying disease
progression in similar patients.
Amgen shares recently traded up 3.9% to $54.15.
"We believe the positive trend coupled with a robust [progression free
survival] benefit will be adequate to support regulatory approval," J.P. Morgan
analyst Geoffrey Meacham wrote in a note to clients.
He said that "modest" use of Vectibix in new patients, and an increase in
patients who failed previous treatment, could boost his 2012 sales view of $445
million by about $300 million.
Deutsche Bank analyst Mark Schoenebaum wrote that an overall survival benefit
would have been "a nice upside surprise," but warned that Thursday's news should
have no effect on the stock.
Amgen is "encouraged" by the positive trend in overall survival, according to
a statement. A spokeswoman said the company expects to discuss the data with
global regulatory agencies, but declined to comment further.
The study used Vectibix in newly diagnosed patients without a mutation in the
KRAS gene - which occurs in about 40% of colorectal cancer patients. Analysis of
past studies of Vectibix and Erbitux, both so-called EGFR inhibitors, has shown
they are ineffective in such patients.
Despite the drug's failure in extending survival, Meacham believes Amgen will
have a strong argument to bring regulators because patients in the placebo arm
likely switched to using Vectibix when their disease began to progress, which
could make it hard to show a definitive survival benefit.
The mechanism of both Vectibix and Erbitux often causes a distinctive rash in
patients, which may make it harder to prevent patients from knowing which
treatment they are getting in a trial.
Sales of Vectibix in the U.S. dropped 36% in 2008 to $108 million, while
Erbitux sales rose 8% to $739 million.
Vectibix was approved in 2006, more than two years after Erbitux, but sales
have struggled since Amgen discontinued a colorectal cancer trial in 2007 after
seeing a higher death rate in those on the drug. The study used Vectibix with
Roche Holding AG's (RHHBY) Avastin, along with a chemotherapy regimen.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com
(END) Dow Jones Newswires
11-05-091150ET
Copyright (c) 2009 Dow Jones & Company, Inc.
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