The FDA Approves New Higher-Dose Aricept® For The Treatment Of Moderate-To-Severe Alzheimer's Disease

July 26, 2010

Adapted from Eisai Inc.

Eisai Inc. and Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) approved a new once-daily, higher-dose Aricept (donepezil HCl) 23 milligram (mg) tablet for the treatment of moderate-to-severe Alzheimer's disease (AD). Aricept 23 mg tablet offers another dosing option for patients with moderate-to-severe AD, for whom few treatments are available.

The approval of Aricept 23 mg tablet is based on data from a large head-to-head study of Aricept 23 mg tablet versus Aricept 10 mg tablet in over 1,400 patients with moderate-to-severe AD. The Aricept 23 mg tablet demonstrated a statistically significant improvement in cognition but did not achieve statistically significant improvement in global function, as compared to Aricept 10 mg tablet.

"Slowing the decline of cognitive symptoms is important at all stages of Alzheimer's disease," said Dr. Martin R. Farlow, professor and vice-chairman of research, department of neurology, Indiana University School of Medicine and lead author of the pivotal study publication. "Throughout the course of Alzheimer's disease, caregivers are usually the first to notice changes in cognition. It's important for families to talk with their doctor when they notice a worsening in cognitive function in their loved ones to reevaluate therapeutic needs."

Based on the approved label, the recommended starting dose of Aricept is 5 mg once daily and can be increased to Aricept 10 mg once daily after four-to-six weeks. Moderate-to-severe AD patients who are established on a regimen of Aricept 10 mg tablet for at least three months are candidates for dose escalation to Aricept 23 mg tablet.

Nausea, vomiting, diarrhea and anorexia were the most common adverse events noted in the pivotal study of Aricept 23 mg tablet.

"We have a long-standing commitment to the AD community and recognize that there are few treatment options available," said Lonnel Coats, president and CEO, Eisai Inc. "In drawing upon our heritage, we are proud to offer a new dosing option to caregivers and patients living with this debilitating condition."

About Aricept (donepezil HCl)

Aricept is the first and only prescription medication approved by the FDA for the treatment of all stages of AD—mild, moderate and severe dementia of the Alzheimer's type. It is not a cure for AD, but Aricept may help provide symptomatic benefits for some patients. Aricept may work differently for each person. For those who respond, symptoms may improve, they may stabilize or they may progress more slowly than without Aricept. Aricept is currently available in 5 mg tablet, 10 mg tablet, orally disintegrating tablet (5 mg and 10 mg) and now 23 mg tablet. The Aricept 23 mg tablet is expected to be available in U.S. pharmacies in August. Based upon the submission of the Aricept 23 mg tablet clinical trial data to the FDA, Aricept 23 mg tablet is expected to have three years of data exclusivity in the United States. Aricept is co-promoted in the United States by Eisai Inc. and Pfizer Inc.

Important Safety Information

Aricept may not be for everyone. People at risk for stomach ulcers or who take certain other medicines should tell their doctors because serious stomach problems, such as bleeding, may get worse.

People at risk for certain heart conditions should tell their doctor before starting Aricept because they may experience fainting. People with serious lung conditions and difficulty breathing, bladder problems or seizures should tell their doctor before using Aricept. Aricept 23 mg is associated with weight loss. Check with the doctor if this is a concern. Inform the doctor if the patient needs surgery requiring anesthesia while taking Aricept.

Some people may have nausea, diarrhea, difficulty sleeping, vomiting or muscle cramps. Incidence of nausea and vomiting were markedly greater in patients taking Aricept 23 mg/day versus patients taking Aricept 10 mg/day. Some people may feel tired or may have loss of appetite. If they persist, please talk to the doctor.

For Full Prescribing and Patient Information, please visit www.eisai.com.

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