• 13 DE
• 14 EN

• 9 Home
• 10 Contact
• 11 Sitemap

• 7 Press
  • 7.1 Press Releases
    • 7.1.1 Company
      • 7.1.1.1 2000
      • 7.1.1.2 2001
      • 7.1.1.3 2002
      • 7.1.1.4 2003
      • 7.1.1.5 2004
      • 7.1.1.6 2005
      • 7.1.1.7 2006
      • 7.1.1.8 2007
      • 7.1.1.9 2008
    • 7.1.2 Health
  • 7.2 Photos & Logos

Alzheimer’s Drug from Merz Recommended for Approval in the USA

Frankfurt am Main, 25.09.2003

The Alzheimer’s drug from Merz with the active ingredient Memantine has been unanimously approved by all members of the Scientific Advisory Committee of US Federal Drug Administration (FDA). Forest Laboratories, an American pharmaceutical company specializing in the field of neurology and psychiatry, has acquired a license from Merz for the exclusive development and marketing of this drug in the USA. The FDA will take the Scientific Committee’s recommendation into consideration in its decision regarding the approval of Memantine in the USA. The decision is expected to be made by the end of 2003. A few months later, Memantine would be introduced to the American market under the name Namenda.

“Memantine was approved in Europe last year in a central process under the trade name Axura®. It already provides help for many patients in Europe with moderate to severe Alzheimer’s disease who previously had no possibilities for treatment,” said Dr. Jochen Hückmann, Chief Executive Officer of Merz Pharma GmbH & Co. KGaA. “We feel that today’s vote of the Scientific Advisory Committee fully confirms the positive results of our clinical studies and last year’s decision of the European approval authority. We now expect that Memantine will soon facilitate daily life for these patients, their families, and their caregivers in the USA.”

The Alzheimer’s drug Axura® from Merz with the active ingredient Memantine is the first drug worldwide that can be used to treat moderate to severe Alzheimer dementia. The drug significantly facilitates the daily life of patients with advanced to severe Alzheimer’s so that for example they can eat by themselves again and wash themselves. Through the improved general conditions, the cost of caregiving for each patient can be reduced by up to 10,000 euros a year, as Anders Wimo et al. demonstrated this year in a study in Pharmaeconomics.

“In several controlled clinical studies, Memantine proved its significant and lasting advantages for patients with moderate to severe Alzheimer’s disease,“ said Prof. Dr. med. Lawrence Olanoff, Executive Vice President of Research and Development at Forest Laboratories. ”Memantine is the first active ingredient in a new generation of Alzheimer drugs with a mechanism of action that is very different from previous therapeutic approaches. We will now work closely with the FDA in order to achieve the approval of Memantine in the USA as quickly as possible. A few months later, Memantine should then be available in the USA as well.”

The Scientific Advisory Committee of the FDA, which encompassed experts from the fields of dementia and other neurological disturbances, reviewed scientific data from two placebo-controlled Phase III clinical studies conducted in the USA and one study conducted in Europe.

“A large number of people are already suffering from Alzheimer’s today, but in the future the number of patients will rise exponentially,” said Dr. med. Steven DeKosky, Chairman of the Neurology Department at the University of Pittsburgh and a presenter to the Scientific Advisory Committee. “Right now, these people are left to face their disease alone. If Memantine is approved, this innovative new therapy will finally be available for patients in the USA as well.”

About Merz (www.merz.de):

Merz Pharmaceuticals, as a member of Merz Pharma, is an innovative and international healthcare company, specializing in the research, development and marketing of drugs 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 indications that are covered by Merz are hepatology/metabolic diseases and dermatology and metabolic diseases.

For further information please contact:

Dr. Andrea Kreisselmeier
Head of Corporate Communications
Merz Pharma GmbH & Co. KGaA
Eckenheimer Landstrasse 100
60318 Frankfurt am Main
Germany

Phone: +49 - (0)69 / 15 03 - 853
Fax: +49 - (0)69 / 15 03 - 400
E-Mail: andrea.kreisselmeier@merz.de

• 0.1 A-
• 0.2 A
• 0.3 A+
• 0.4 Print

Search

Search

Search

Login for Professionals

Login for Professionals

Merz DocCheck User Password

new user

German Websites

• Alzheimer´s
• Depression
• Dystonia
• Hair Loss
• Hyal-System
• Liver Disease
• Parkinson´s