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Application to Expand Memantine Approval to Include Mild Stages of Alzheimer’s Disease

Frankfurt am Main, 16.11.2004

Merz Pharma KGaA in Frankfurt today announced the application for an expansion of the existing approval of Memantine for moderate to severe Alzheimer’s disease (AD) to include the mild stages of AD as well.

Core of the approval documentation are positive results of clinical studies that show efficacy of memantine in mild to moderate Alzheimer´s disease. An application to this end was submitted with the European Medicines Agency or EMEA in October 2004. The supplemental New Drug Application (sNDA) submitted this fall by the marketing partner for Merz in the USA, Forest Laboratories, Inc., to the United States Food and Drug Administration (FDA) was accepted yesterday. If the applications are successful, Memantine would be the first substance worldwide to be approved for treating all stages of Alzheimer’s disease.

“The approval of Memantine for the mild stages of Alzheimer’s disease would be an important milestone for people affected by Alzheimer’s. It would give them access from the very start to a highly effective and well-tolerated drug,” said Dr. Hans-Jörg Möbius, Managing Director of Merz Pharmaceuticals and head of research and development at Merz.

At this time, the only drugs approved for the treatment of the mild stages of Alzheimer’s disease are acetylcholinesterase inhibitors. Memantine is the only subtance currently approved worldwide for the treatment of moderate to severe Alzheimer’s disease. Patients could then benefit from the onset from the enhancement of cognitive abilities and the facilitation of activities of daily living afforded by this well-tolerated drug. Changing drugs during the course of the disease would then no longer be necessary.

About Merz Pharmaceuticals (www.merz.com):

Merz Pharmaceuticals, as a member of Merz Pharma, is an innovative and international healthcare company, specializing in the research, development and marketing of pharmaceuticals for the treatment of neurological and psychiatric diseases. Merz is a leader in the field of Alzheimer research and developed Memantine as the first drug for the treatment of moderate to severe Alzheimer's. Other franchise covered by Merz are hepatology/metabolic diseases and dermatology.

More information for professionals.

For further information please contact:

Merz Pharma GmbH & Co. KGaA
Corporate Communications
Nicole Giesler
Phone: +49 (0) 69 / 15 03 - 411
Fax: +49 (0) 69 / 15 03 - 400
E-Mail: nicole.giesler@merz.de

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