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Merz Alzheimer drug effective in treating mild, moderate and severe Alzheimer’s disease (AD)

Frankfurt am Main, 07.01.2004

Initial results from a US clinical study with memantine published today show safety and efficacy of Merz’ Alzheimer’s drug, which contains memantine as an active ingredient, for the early stages of AD. Conducted by Forest Laboratories, Merz’ US development and marketing partner, the study showed a statistically significant improvement of patients’ cognitive performance and overall status in cases of mild to moderate Alzheimer’s as compared with placebo. With this result Axura® is the only Alzheimer drug demonstrating efficacy in clinical trials for all stages of severity in AD.

“We are pleased that the results of the study demonstrate the efficacy of memantine for the early stages of AD. With the results of this study and given the good tolerability of memantine, many more patients may be treated effectively in the future,” stated Dr. Hans J. Möbius, Chief Scientific Officer of Merz Pharmaceuticals. “With regard to an extension of our registration also for mild to moderate Alzheimer’s we will initiate a dialogue with the EU regulatory authorities (EMEA).”

As the first treatment worldwide for advanced stages of Alzheimer’s (moderate to severe Alzheimer’s Disease), memantine has been approved via Centralized Procedure in the EU (May 2002), in many other countries and in the US (October 2003). The number of Alzheimer’s patients is estimated to be approximately 850,000¹ in Germany, 4 million in the US² and 15 million³ worldwide. In Germany and other countries, memantine is marketed by Merz under the AXURA® brand name. In the US, memantine will be introduced by Forest under the NAMENDA® brand as of January 2004.

1. Official report on aging in Germany
2. Alzheimer’s Association: www.alz.org/AboutAD/Statistics.htm
3. Geriatrics, February 2003

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 the first drug for the treatment of moderate to severe Alzheimer’s. Other franchise covered by Merz are hepatology/ metabolic diseases and dermatology.

For further information please contact:

Friedhelm Klingenburg
Senior Vice President Corporate Development
Merz Pharma GmbH & Co. KGaA

Phone: +49 - (0) 69 / 15 03 - 213
Fax: +49 - (0) 69 / 15 03 - 400
E-Mail: friedhelm.klingenburg@merz.de

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