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Revotar to initiate phase IIa study of Bimosiamose to support development in COPD

BERLIN/Hennigsdorf (Germany), July 3, 2009 - Revotar Biopharmaceuticals AG today announced the submission of a Phase IIa study to evaluate the effect of Bimosiamose on ozone-induced sputum neutrophilia in healthy subjects with a new controlled breathing nebulizer device.

The trial is designed as a double-blind, placebo controlled, randomized cross-over study comprising 18 non-smoking healthy ozone-responsive volunteers able to produce sputum. Each subject will receive nebulized Bimosiamose solution or vehicle for four consecutive days twice daily in two subsequent periods according to a randomization plan and separated by a wash-out phase (cross-over). Primary endpoint will be the difference of neutrophil counts in induced sputum following Bimosiamose and placebo; secondary variables cover three biomarkers: matrix-metalloproteinase-9 (MMP), interleukin-8 (IL-8) and myeloperoxidase (MPO). The study is conducted at two centers in Germany.

Inhaled ozone in combination with physical exercise is an established standardized method to induce in healthy volunteers a reversible airway inflammation characterized by neutrophils and cytokines quantifiable in induced sputum. This is an accepted clinical model for the investigation of new anti-inflammatory therapies in chronic obstructive pulmonary disease (COPD).

'This trial will substantiate the mode of action of the inhaled pan-selectin antagonist Bimosiamose with a controlled breathing device', said Prof. Wolfgang Meyer-Sabellek, Chief Medical Officer of Revotar. 'Together with the results from an upcoming multi-centre Phase II study in patients with COPD they will provide a strong basis for further clinical development of the compound in COPD.'

'There is a huge market need for efficacious and safe anti-inflammatory treatments in COPD', added Dr Martin Pöhlchen, CEO of Revotar. 'Final results of the submitted Phase IIa ozone challenge study with Bimosiamose are expected until end QII in 2010.'

About COPD
Chronic Obstructive Pulmonary Disease (COPD) comprises many serious conditions affecting the lung. More than 30 million people are living with COPD worldwide. COPD is the fourth leading cause of death and is responsible for more than 120,000 deaths a year in the US and Western Europe alone. The disease costs the US healthcare system US$40 billion per year.

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 over 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 2007 and 2008 Revotar raised approximately 9 million EUR and has further commitments of 3 to 4 million EUR based on certain preconditions to be met.

Dr Martin Pöhlchen, CEO
Revotar Biopharmaceuticals AG
Neuendorfstr. 24a
D-16761 Hennigsdorf / Germany
Phone: +49-3302-2025010
Fax: +49-3302-2025030

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REVOTAR Biopharmaceuticals

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