Revotar Biopharmaceuticals Starts Phase II Clinical Trial in Psoriasis with its Bimosiamose 5% Cream

BERLIN/Hennigsdorf (Germany), January 29, 2009 - Revotar Biopharmaceuticals AG today announced the start of a Phase II study to evaluate the safety and efficacy of Bimosiamose 5% Cream for the treatment of patients with chronic plaque-type psoriasis. The cream is a new topical formulation of the pan-selectin antagonist Bimosiamose.The Phase II study is designed as a randomized, double-blind, placebo-controlled multi-center study comprising 105 male patients aged 18 years or older or postmenopausal or sterile female patients. All study participants suffer from chronic plaque-type psoriasis with a Psoriasis Area and Severity Index (PASI) score of 5-15 and a Physician’s Global Assessment (PGA) of moderate or less. In the trial, up to twenty percent of the body surface area will be treated twice daily for 112 days with Bimosiamose 5% Cream or placebo cream. Primary endpoint will be from baseline of modified PASI at Day 112 by at least 50% (end of treatment). The study is conducted at 12 investigational sites in Germany.

A sub-study comprising up to 33 patients will investigate histological and immunohistological changes and alterations of psoriasis-relevant mediators in the blood. In addition, shifts in the expression profile of psoriasis-relevant mediators and of the topoproteome will be studied using skin biopsies of these patients.

Already, Bimosiamose has been tested successfully in various indications (psoriasis, asthma and COPD) in Phase I and Phase IIa trials. "In a Phase I study in psoriasis completed last year, we have already seen that Bimosiamose 5% Cream is safe and well tolerated and exhibits only very limited systemic exposure," said Prof Wolfgang Meyer-Sabellek, Chief Medical Officer of Revotar, previously Senior Vice President Research & Development at AstraZeneca. "We are now looking forward to explore the efficacy of our product. The trial is sufficiently powered to achieve significant results." "There is a huge market need for efficacious and safe topical treatments in psoriasis", added Dr. Martin Pöhlchen, CEO of Revotar. "With Bimosiamose 5% Cream, we hope to bring a new mechanism of action for topical applications to market. Results are expected for the first quarter of 2010." Revotar will attend the BioPartnering conference in Vancouver on February 8-10, 2009. About Revotar Biopharmaceutical AG Revotar develops innovative drugs for inflammatory indications such as psoriasis, asthma, chronic obstructive pulmonary disease (COPD) and acute lung injury (ALI). Its lead candidate Bimosiamose, a pan-selectin antagonist, has already passed several clinical phase I and phase IIa trials in asthma, COPD and psoriasis with a good safety and efficacy profile in nearly 200 patients and volunteers. In summer 2006, Revotar announced a Start-Up Development Agreement with a US Pharma company for the further development of Bimosiamose in one major disease area. In September 2008, Revotar announced the successful first closing of its Series A financing round of 5.3 million EUR, with an additional commitment of 3 million EUR based on certain preconditions to be met.

Contact Address: Dr Martin Pöhlchen, CEO Revotar Biopharmaceuticals AG Neuendorfstr. 24a D-16761 Hennigsdorf / Germany Phone: +49-3302-2025010 Fax: +49-3302-2025030 Email: info@revotar-ag.de www.revotar.de

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