EISAI TO PROCEED WITH LEGAL ACTION AGAINST NICE

Eisai, which along with Pfizer markets Aricept (donepezil hydrochloride), announced Friday that it has formally submitted an application to the UK High Court requesting a judicial review of the process by which the National Institute for Health and Clinical Excellence (NICE) decided against allowing Aricept to be prescribed to treat newly diagnosed, mild Alzheimer's disease.

In November 2006 the company called on NICE to withdraw its decision and postpone issuing new guidance on treating Alzheimer's, as well as to disclose the calculation of cost effectiveness it used to make the decision. As a result, Eisai has now applied for permission to proceed with a judicial review in part on the grounds that "the process leading to the [decision] and the new treatment guidance breached the principles of procedural fairness."

"We are disappointed that Eisai Limited have taken this step," Andrew Dillon, CEO of NICE, said in response to the company's announcement. "The reality is that, for Alzheimer's disease, drugs are only part of the care that needs to be offered."

In addition to Eisai's challenge, the Alzheimer's Society today announced its intention to challenge NICE's decision on Alzheimer's treatments in the High Court. The group has also submitted a request for judicial review.