Eisai and Pfizer rolled out a new set of clinical trial numbers on their long-acting version of Aricept (donepezil), with the experimental 23 milligram extended-release formulation besting the 10 milligram immediate-release drug that the Japanese company relies on for the lion's share of its U.S. revenue.
In a study which enrolled 1,476 patients, researchers said that the once-daily 23 milligram therapy proved more effective in maintaining and improving brain function than the marketed drug, according to a report from Bloomberg. Eisai faces a July 24 PDUFA date on its FDA application for the long-acting form of Aricept. Data on a patch version of the drug will be submitted this month.
Eisai has a lot riding on these new formulations. Aricept, the world's best-selling Alzheimer's drug, provides the company with 60 percent of its U.S. revenue but loses patent protection in November, a milestone that will be followed by a rapid loss in sales. A host of new Alzheimer's therapies are now being studied as developers attempt to do more than treat symptoms of the disease.
Aricept garnered $3.64 billion in sales during the last fiscal year, but Eisai says it expects sales to swiftly plunge by 50 percent once it loses patent protection. The Japanese pharma company says its long-acting version should earn $600 million a year once it reaches its peak.
- here's the story from Bloomberg
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