Sanofi and Regeneron Pharmaceuticals Inc. (REGN:US) 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.
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.
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.
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