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Aricept patch filed with FDA

The US FDA has accepted for review a New Drug Application for a patch version of Eisai's blockbuster Alzheimer's disease drug Aricept

The US Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for a patch version of Eisai's blockbuster Alzheimer's disease drug Aricept (donepezil).

The filing comes as the oral formulation of the drug is facing patent expiry.  Eisai said earlier this year that it expects annual US sales of Aricept to plummet from $2bn to $800m by 2013 because of the introduction of generic competition.

The transdermal product, which is expected to improve patient compliance, will be co-promoted by Eisai and Pfizer if it is approved in the US. Pfizer already co-promotes the oral version of the drug in the US.

The weekly patch was developed through a partnership between Eisai and Teikoku Pharma USA, a subsidiary of Japan's Teikoku Seiyaku that specialises in developing transdermal formulation of medicines.

The NDA, which was submitted on June 30, seeks approval of the patch for mild, moderate and severe stages of Alzheimer's disease. The oral formulation of Aricept, which is sold as regular tablets and disintegrating tablets, must be taken every day. It is the only drug currently approved by the FDA for all three stages of the disease.

Earlier this year, the FDA approved a high-dose, 23mg formulation of the oral drug, which was previously available only in 5mg and 10mg tablets. The high-dose product has three years of marketing exclusivity.

If the patch version of the drug is cleared for marketing, it will compete with Novartis' Exelon Patch, which is approved for mild to moderate Alzheimer's disease, as well as mild to moderate Parkinson's disease dementia. The Novartis patch was cleared by the FDA in 2007 as the first transdermal drug for Alzheimer's disease.

20th September 2010

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