A patch aimed to deliver Aricept, the world’s best-selling Alzheimer’s disease treatment, through the skin was deemed not ready for U.S. approval, its maker Eisai Co. said.
The Food and Drug Administration questioned usage of the patch in advising that it’s not ready to approve the application. The Tokyo-based drugmaker holds marketing rights in the U.S. and will co-promote the Aricept patch with Pfizer Inc. (PFE) if it’s approved, Eisai said in a statement today.
Eisai won’t comment on whether further discussions with the FDA will delay sales of the patch, previously slated for as early as June, said Takeshi Shimizu, a company spokesman.
Eisai is counting on new Aricept formulations, including the skin patch and a long-acting tablet already approved, to curb a slump in demand caused by patients in the U.S. switching to cheaper generic versions made by Ranbaxy Laboratories Ltd. (RBXY) Eisai cut its full-year sales forecast in February on lower- than-expected sales of Aricept and said it would cut 900 positions to focus on its cancer business.
The price of Aricept, which accounted for 40 percent of Eisai’s revenue in the year ended March 2010 or 322.8 billion yen ($3.9 billion), fell 70 percent after Ranbaxy started selling its copy, Arun Sawhney, the Indian drugmaker’s managing director, said in February.
Today’s announcement was made after markets in Japan closed. Eisai fell 0.5 percent to a five-week low of 2,918 yen at the 3 p.m. close of trading in Tokyo today, while the benchmark Topix Index dropped 0.2 percent.
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