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Phase 3 Study Demonstrate High Efficacy of Oral Contraceptive Belara in Treatment of Acne and Seborrhea

AACHEN, GERMANY -- June 2, 2006 -- At the 9^th Congress of the European Society of Contraception, the international, research-based, pharmaceutical company Grünenthal presented the results of their phase 3 Balance Study, which evaluated the efficacy and safety of Belara® during administration for six medication cycles in patients with papulo-pustular acne.

Belara is a modern oral hormonal contraceptive consisting of a monophasic combination of 2 mg chlormadi­none acetate (CMA) and 0.03 mg ethinyl estradiol.

"The results of the study demonstrate that due to the anti-androgenic properties of its CMA component, Belara proved to be superior to placebo, not only in the treatment of acne of the face, décolleté and back, but also in the treatment of seborrhea," said Prof. U. Gaspard, of the Université de Ličge in Belgium, who presented the results.

The results show that there is a distinct, statistically-significant difference in response rates between the users of Belara and those of placebo (defined as ł50% reduction in facial lesion count): 64,1% of the women treated with Belara had at least 50% less acne after six medication cycles, while a similar reduction in the placebo group was only seen in 43,7% of the women. Acne in the face was reduced by 63,6% (compared to 32,4% on placebo), acne on the back reduced by 86% (compared to 58,3% on placebo) and acne in the décolleté was even reduced by 92,2% (compared to 50% on placebo).

The study also revealed that, statistically, Belara is more effective, as well, in treating seborrhea compared to placebo. Already, after six medication cycles, seborrhea was absent in 41,5% of the women taking Belara, but only in 23,9% of the women receiving placebo.

In addition, Prof. U. Gaspard, of the Université de Ličge in Belgium added: "Furthermore, Belara scored significantly higher in patients' satisfaction with the treatment compared to placebo." Over 70% of the women on Belara reported satisfactory and very satisfactory improvement of hair and skin, compared to only 41% of the patients under placebo.

Belara's additional benefits for skin and hair contribute to the overall compliance and therefore to the prevention of unwanted pregnancies

Modern oral hormonal contraceptives are, in general, safe and effective. Several studies show that the main reason for unwanted pregnancies, therefore, is poor compliance resulting in missed pills and spontaneous discontinua­tion of oral contraceptive use. So-called minor side effects of the pill, such as weight gain, mood changes or greasy skin and hair are often predominant factors in women's decisions to stop taking the pill. Skin and hair problems are, therefore, not only cosmetically relevant but an important factor to increase compliance.

Belara has an exceptional compliance rate, due to its outstanding Pearl index, its regular and trouble-free cycles, its metabolic neutrality, the fact that it does not influence libido and mood, its very low side-effects rate, and, especially, its ability to not affect weight.

In addition to these benefits, the anti-androgenic efficacy of Belara on acne and seborrhea provides the physician with a new alternative to meet the needs of women who wish for an improvement of skin and hair besides safe and effective oral contraception. This, once more, contributes to the overall compliance.

About Belara
Belara is a modern oral contraceptive containing 0.03 mg ethinyl estradiol and 2 mg chlormadinone acetate. It is available in Germany, France, Spain, Portugal, Switzerland, Russia and Czech Republic, as well as in a variety of Latin American countries (e.g. Chile, Peru, Ecuador, Mexico, Colombia). Belara is now also available, since May, in Italy and will be available in June in Austria. Belara has already been ranked Nş2 in the German oral contraception market segment and Nş1 among teenage users. Further launches will take place in other European countries throughout the year.

About Grünenthal GmbH
Grünenthal GmbH is an independent and international pharmaceutical company, concentrating on pain therapy, gynaecology and anti-infectives. It was founded in Stolberg in 1946. The operative unit in Germany is Grünenthal GmbH located in Aachen, where production, research and development are concentrated. The research and development pipeline contains new chemical entities and advanced pharmaceutical delivery technologies. Grünenthal GmbH is currently represented in 25 countries with affiliates in virtually all European countries. Grünenthal GmbH has production sites in seven countries. Grünenthal GmbH employs about 1.800 people in Germany and 4.800 world-wide.

If you have any queries, please contact Anke Krüger-Hellwig

Phone +49 241 569-2858, Fax +49 241 569-1486

52099 Aachen, Germany

anke.krueger-hellwig@grunenthal.com

www. grunenthal.com


SOURCE: Grünenthal GmbH

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