Eisai Can Sell Breast-Cancer Drug
Eisai Can Sell Breast-Cancer Drug [The News & Observer, Raleigh, N.C.]
From News & Observer (Raleigh, NC) (November 16, 2010)
Nov. 16--Japanese drug maker Eisai won regulatory approval Monday to sell its new treatment for late-stage breast cancer.
The drug, Halaven, is a synthetic form of a compound found in sea sponges that works by inhibiting cancer cell growth, the Food and Drug Administration wrote in a statement.
Though the drug is made outside the United States, Eisai will label and package it for the U.S. market in a $100 million, 65,000- square-foot facility that opened in May on its Research Triangle Park campus.
Eisai has its U.S. headquarters in New Jersey but employs about 325 people at its main manufacturing campus in RTP.
The injectable drug, also known as eribulin mesylate, will be the first oncology product packaged at the new facility. Eisai officials have said they may add more jobs in RTP as the cancer business expands.
There are "no current plans" to hire more RTP workers to support Halaven, Eisai spokeswoman Judee Shuler said. But some workers that now package Aricept, a treatment for Alzheimer’s disease, will be shifted to Halaven, she said.
Eisai will lose patent protection on Aricept this month and is looking for new products to offset revenue lost to generic rivals.
In clinical tests, Halavenwas safe and helped extend by several months the lives of women with metastatic breast cancer who had received at least two rounds of chemotherapy, the FDA wrote. "Halaven shows a clear survival benefit and is an important new option for women," said Richard Pazdur, the FDA’s director of the Office of Oncology Drug Products.
Eisai has a 190,000- square-foot manufacturing and research facility in RTP. That factory makes Aricept and other products.
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Posted: November 2010