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Merz provides evidential proof of its success in tinnitus study – considerable expansion of the research & development department

Frankfurt am Main, 05.07.2007

Positive study results have been presented to the pharmaceutical company Merz for its active ingredient Neramexane: a phase-IIb study on the treatment of tinnitus with Neramexane, a new substance developed by Merz, achieved positive results concerning clinical effectiveness and patient tolerability. The company will be considerably expanding the research and development department at its headquarters in Frankfurt during the new fiscal year as well.

With the good results of the phase-IIb study for Neramexane, Merz has once again demonstrated its competence in the research and development of active ingredients for the central nervous system (CNS). "The study results prove that our investment in research and development over the past several years has been worth it," says Dr. Martin Zügel, CEO of Merz Pharmaceuticals GmbH. Plans and preparations for the phase-III stage of testing for Neramexane is next on the list. "We work for the systematic development of our active ingredient and will continue to invest in our company to do so. Merz would like to take on fifty new R&D employees for research projects within the coming months," explains Dr. Alexander Gebauer, Head of Global R&D. The company thereby makes a valuable contribution to securing Germany's status as a pharmaceutical location.

Neramexane: Clinical effectiveness and patient tolerability in the treatment of tinnitus

Within the framework of Neramexane's clinical development for the treatment of tinnitus, Merz concluded a placebo-controlled proof-of-concept and dose-finding study on 15 June 2007. The primary results document its clinical effectiveness and tolerability, thereby creating a foundation for the further clinical development of the substance that was developed by Merz. The randomized, clinical double-blind study was conducted with 429 patients in Germany and Austria. It compared three varying dosages of Neramexane with a placebo (sugar pill). A validated tinnitus questionnaire served the purpose of determining primary target values.

By tinnitus, or a ringing of the ears, it is implied that patients perceive sounds without the existence of an external source for the noise. Tinnitus manifests itself as a sickness that can severely interfere with the ability to sleep, as well as impairing the ability to concentrate and work. It often is accompanied by difficulty hearing and hypersensitivity to sound. It pertains to a disease that is widespread in industrial countries, permanently affecting approximately 0.5 to 1 percent of the population.

Explanation of scientific terms:

Double blind means, in the context of a clinical study, that neither the patient nor the doctor responsible for treatment know which patients are receiving the active ingredient, and which are receiving the placebo.
Randomized means that patients have been divided into two groups (active ingredient and placebo) by random chance.
Placebo-controlled is a study where the results of both groups are compared without intervention.

About Merz

Merz specializes in drugs for the treatment of neurological and psychiatric illnesses and is a leader in the field of Alzheimer's research. Merz developed Memantine, the world's first drug for the treatment of moderate to severe stages of Alzheimer's disease. Among drugs to combat Alzheimer's, Memantine is the second-largest in the world. Another area of competence at Merz is clinical and cosmetic dermatology. Along with the pharmaceuticals market, Merz is active in the healthcare sector outside of pharmacies as well. With its tetesept® and Merz Spezial® brands, in German-speaking countries Merz is a leading provider of products for self-medication, dietary supplements, beauty and wellness.

A Merz subsidiary, Senator GmbH & Co. KGaA, is one of the leading manufacturers of high-quality promotional writing instruments worldwide. The Merz Group employs 1,900 employees worldwide. The company achieved revenues of € 475 million in the 2005/06 fiscal year.

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Merz GmbH & Co. KGaA
Ute Weinhold
Corporate Communications
Eckenheimer Landstraße 100
60318 Frankfurt
Phone: +49-69 / 15 03 889
Fax: +49-69 / 15 03 581
E-Mail: ute.weinhold@merz.de

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