Eisai May Start Skin-Patch Aricept U.S. Sales in 2011

Eisai Co. plans to introduce a skin- patch version of the Aricept Alzheimer’s disease treatment in the U.S. as early as the second quarter of next year to help buffer an anticipated decline in sales of its biggest drug.

Teikoku Seiyaku Co., Eisai’s development partner, submitted patient-trial data to the U.S. Food and Drug Administration on June 30, Lynn Kramer, head of neuroscience product development at the Tokyo-based company, said on a conference call today. The regulator typically takes 10 months to complete a review.

Eisai is counting on new Aricept formulations including the skin patch and a stronger dose tablet approved last week to maintain U.S. sales at half of current levels after patent protection expires in November. Aricept generated about $3.7 billion for Eisai last fiscal year, 60 percent of which came from the U.S., the world’s largest pharmaceutical market.

The drugmaker said the patch would be applied once a week and be as effective as the 10-milligram, once-daily tablet currently sold. Eisai will have three years of exclusive sales for the patch, which “would be very difficult to copy as well,” Kramer said.

Eisai rose 0.6 percent to close at 2,905 yen in Tokyo trading. The shares gained 3.9 percent yesterday, the most in 14 months, after the U.S. FDA said July 23 that it approved a 23- milligram, once-daily Aricept tablet for patients with moderate to severe Alzheimer’s disease.

Existing Patients

The 23-milligram tablet is aimed at patients who have been taking the current formulation for at least three months.

Eisai is considering developing a skin patch of the higher dose Aricept, Kramer said. In February 2009, the company bought rights from closely held Teikoku, based in Kagawa prefecture, southwestern Japan, to sell the patch version in the U.S.

New York-based Pfizer Inc. and Eisai share promotion rights for Aricept in the U.S. and parts of Europe.

Pfizer and Eisai have a combined sales force of 1,300 to sell the higher-dose Aricept in the U.S., where it will have three years of protection from copycat drugs, Lonnel Coats, head of Eisai’s U.S. unit, said on the call.

Sales of the stronger-dose Aricept are estimated to reach at least $600 million by 2012, Coats said.

Eisai is targeting 1 million in annual prescriptions of the new Aricept tablet in three years, Takeshi Shimizu, a company spokesman, said by telephone.

To contact the reporter on this story: Kanoko Matsuyama in Tokyo at kmatsuyama2@bloomberg.net.

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