Sanofi and Regeneron Pharmaceuticals
Inc. (REGN) won U.S. clearance for Zaltrap as a treatment for patients
with advanced colorectal cancer who haven’t been helped by
previous therapy.
The Food and Drug Administration approved the drug for use
in combination with chemotherapy as a so-called second-line
treatment for patients whose colorectal cancer has spread to
other parts of the body, the agency said today in a statement.
Regeneron also sells a medicine with the same active ingredient
aflibercept under the name Eylea to treat wet age-related
macular degeneration, a condition that causes vision loss.
The FDA granted Zaltrap “new molecular entity” status,
which is reserved for drugs considered new and innovative
chemical structures that previously haven’t been used in
clinical practice. FDA grants each stand-alone biologic drug
application new molecular entity status, Stephanie Yao, an FDA
spokeswoman, said. Zaltrap will chemically be called ziv-
aflibercept to distinguish it from Eylea.
“Zaltrap isn’t likely to be a large medicine for Sanofi (SAN),
but getting a cancer drug approved is important for them, after
a series of setbacks in oncology,” Pierre Corby, an analyst at
Aurel BGC in Paris, said in a telephone interview before the
FDA’s decision was announced.
Roche’s Avastin
Patients may first try Roche Holding AG’s Avastin before
Zaltrap, which is used in combination with chemotherapy, Adnan Butt, an analyst for RBC Capital Markets LLC, said today in a
note to clients. A study of 1,226 patients found those who
received Zaltrap plus a chemotherapy called folfiri lived an
average of 13.5 months compared with an average of 12 months for
those receiving chemotherapy plus a placebo, the FDA said.
Sanofi Chief Executive Officer Chris Viehbacher reorganized
the Paris-based company’s oncology business into a full-fledged
division soon after taking over in December 2008. The cancer-
drug unit suffered a blow after its most-promising treatment,
iniparib, failed in a study last year. Sanofi obtained iniparib
in the 2009 acquisition of BiPar Sciences Inc.
Zaltrap failed to help lung cancer patients live longer in
another clinical trial, Sanofi and Tarrytown, New York-based
Regeneron said in 2011. The companies said in April that the
medicine also didn’t improve overall survival in a study
involving patients with a form of prostate cancer known as
androgen-independent.
Annual Sales
As a second-line treatment, Zaltrap may generate peak
annual sales of about 300 million euros ($371 million) by 2018,
said Corby, who has a buy recommendation on Sanofi shares.
Regeneron and Sanofi will split sales of the drug.
Regeneron gained less than 1 percent to $136.96 at the
close of New York trading. The shares have more than doubled
this year.
The medicine is designed to control cancer growth by
blocking the blood supply to the tumor. More than 143,000 new
cases of colorectal cancer are likely to be diagnosed in the
U.S. this year, according to the National Cancer Institute.
Colorectal cancer is the fourth most commonly diagnosed
cancer and the fourth leading cause of cancer death in the U.S.
Zaltrap also will include a boxed warning that it can cause
severe and sometimes fatal bleeding, including gastrointestinal
bleeding, and the development of holes in the gastrointestinal
tract, the FDA said in its statement. The medicine can make it
more difficult for wounds to heal, according to the agency.
Zaltrap is scheduled to be approved by European regulators
in the fourth quarter, Viehbacher said during a July 26
conference call with analysts.
To contact the reporters on this story:
Albertina Torsoli in Paris at
atorsoli@bloomberg.net;
Anna Edney in Washington at
aedney@bloomberg.net
To contact the editors responsible for this story:
Phil Serafino at
pserafino@bloomberg.net;
Reg Gale at
rgale5@bloomberg.net
Article source: http://www.bloomberg.com/news/2012-08-03/sanofi-regeneron-win-u-s-approval-for-cancer-medicine-zaltrap.html