Kerentech

A study found that Alzheimer’s disease patients that used the new long-acting version of Aricept were more likely to maintain or improve brain function than those who continued using  the older formulation.

Improvement benefited the most to people with more advanced Alzheimer’s. Comparison between the experimental  23-milligram tablet taken once daily with the immediate-release, 10-milligram pill now used,  was favorable to the new formulation,  according to the results released today at the International Conference on Alzheimer’s Disease in Honolulu. No new side effects were seen, the study said.

Tokyo-based Eisai is counting on long-acting and patch versions of Aricept, the world’s best-selling drug for Alzheimer’s, to buffer a potential sales decline when the medicine loses patent protection in the U.S. in November. The company, which generates 60 percent of Aricept’s global sales in the U.S., expects the drug’s revenue in that market to fall about 50 percent in the year ending March 2012, it said in March.

The new formulation is being reviewed by the U.S. Food and Drug Administration, which will make a decision by July 24. It plans to submit data this quarter for regulatory approval to sell the patch version. Eisai aims for the long-acting version of Aricept to reach more than $600 million in peak sales.

The study involved 1,467 people who had moderate to severe Alzheimer’s disease and underwent treatment with the immediate- release Aricept pill for more than three months. Patients then took placebo and either the immediate-release or extended- release pill for six months.

Aricept sales for Eisai rose 6.3 percent to 322.8 billion yen ($3.64 billion) in the year ended March 31, accounting for 40 percent of revenue. The Japanese company pays New York-based Pfizer a fee for co-promotion of Aricept in the U.S. and parts of Europe.