US FDA not ready to approve Eisai Aricept Patch; Lipacreon and Halaven OKed in Japan

Japanese drug major Eisai (TYO: 4523) says that the US Food and Drug Administration has issued a Complete Response Letter to Teikoku Pharma USA regarding the New Drug Application of the Aricept Patch (donepezil transdermal system). The Aricept Patch was developed by Teikoku and its subsidiaries and, along with Eisai, has seeking approval of the weekly Aricept Patch for the treatment of mild, moderate and severe stages of Alzheimer’s disease.

The FDA issues a Complete Response Letter to indicate that the review cycle of an application is complete and the application is not ready for approval. Eisai will work with Teikoku to assess the CRL and determine next steps. Eisai holds the marketing rights in the USA and will co-promote the Aricept Patch with drugs behemoth Pfizer (NYSE: PFE) if approved.

The Aricept Patch is a weekly transdermal patch that was developed to provide an alternative formulation for Alzheimer’s patients. Aricept in tablet formulation is already the world’s leading Alzheimer’s drug and generated fiscal 2010/11 sales of around $3.9 billion. However, the drug is now facing generic completion, notably from India’s Ranbaxy Laboratories, and has seen the branded product’s price tumble 70% after the copy product came to the US market in February.