AXURA® effective in treating mild, moderate and severe Alzheimer's disease (AD)

Frankfurt am Main, January 7th, 2004 – Initial results from a US clinical study with memantine published today show safety and efficacy of Merz’ Alzheimer’s drug Axura®, 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.

Study Design

The double-blind, parallel group, placebo-controlled Phase III study was designed to evaluate the safety and efficacy of memantine given as monotherapy at a daily dosage of 10 mg BID to patients with mild to moderate Alzheimer’s disease. The six-month study was conducted at 35 US centers and included 403 patients.

Study Results

Results from the study show that patients receiving memantine performed significantly better than patients receiving placebo on both primary outcome measures; the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) (p = 0.003) a measure of cognitive function, and the Clinician’s Interview Based Impression of Change – Plus version (CIBIC-plus), a global measure of overall status (p = 0.004). Memantine was well tolerated in the study and memantine patients only experienced adverse events at overall rates that were comparable to patients on placebo.

Simultaneously with this announcement, H. Lundbeck released the preliminary results of a Phase III, six-month, double-blind study performed in Europe. This trial randomized a total of 470 patients with mild to moderate Alzheimer’s disease from 65 centers to 20 mg memantine daily or placebo. In the prospectively defined primary analysis, the difference in values for the primary endpoints, the ADAS-cog and the CIBIC-plus, between the two groups was statistically significantly in favour of the memantine treatment group versus the placebo group at multiple time points, while at week 24 although numerical improvement was observed statistical significance was not reached due to higher than expected response in the placebo group. As in the USUS trial, adverse event rates overall were similar for the two treatment groups.

“The results of these studies suggest Axura® as an unique approach to all stages of Alzheimer’s disease. This translates into a significant improvement for patients, caregivers and relatives,” comments Dr. Jochen Hückmann, CEO and President of Merz Pharma GmbH & Co. KGaA. “These results encourage us to continue to intensify our CNS research.”

1. Official report on aging in Germany
2. Alzheimer’s Association: www.alz.org/AboutAD/statistics.asp
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.

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