Eisai plans cancer drug sale in USA as aricept protections ends

Eisai Co. will start selling its new breast-cancer treatment on Nov. 26 as its biggest drug, the Aricept treatment for Alzheimer’s disease, loses patent protection.
Eisai will seek regulatory approval for earlier use of the eribulin mesylate drug in patients with breast cancer than currently allowed, and aims for annual sales of more than $1 billion, Chief Executive Officer Haruo Naito said at a briefing in Tokyo today. The medicine won U.S. approval yesterday and is Eisai’s first original treatment in the world’s biggest drug market in more than a decade.
The U.S. Food and Drug Administration said it cleared eribulin mesylate for women with advanced breast cancer after at least two prior chemotherapy regimens. The drug approval, which came more than six weeks earlier than the expected deadline, will help Tokyo-based Eisai counter an expected revenue loss to generic competition when the patent on Aricept expires Nov. 25.
“The approval came earlier than I thought it would,” Yasuhiro Nakazawa, an equities analyst at Mitsubishi UFJ Morgan Stanley Securities Co. in Tokyo, said by telephone. “The potential of the drug depends on whether it gets approval to be used as the first and second line of treatment.”
Eisai rose 0.2 percent to 2,872 yen at the 3 p.m. close in Tokyo trading, after climbing as much as 1.7 percent. The Nikkei 225 Stock Average dropped 0.3 percent.
The drug, to be sold under the brand name Halaven, will compete with Basel, Switzerland-based Roche Holding AG’s Xeloda and New York-based Bristol-Myers Squibb Co.’s Ixempra.
‘Clear Survival Benefit’
Breast cancer is expected to strike about 207,000 women in the U.S. this year and cause almost 40,000 deaths, according to the National Cancer Institute. Halaven prolonged survival by two-and-a-half months compared with current single-agent therapies in a study of 762 women with advanced stages of the disease.
“There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies,” Richard Pazdur, director of the FDA’s Office of Oncology Drug Products, said in a statement. “Halaven shows a clear survival benefit and is an important new option for women.”
The injectable medicine is a synthetic form of a substance derived from a sea sponge. The drug is thought to work by preventing tumor cells from growing, according to the FDA.

**Published by "Bloomberg"