Lainate, Italy – April 1, 2008 – Cosmo Pharmaceuticals SpA (“Cosmo”) (SWX: COPN), announced today that the Austrian Agency for Health and Food Safety (“AGES”) has authorised the commencement of a Phase I clinical study of its novel anti-androgen based cream, CB-03-01, for the topical treatment of skin disorders, including acne, alopecia and hirsutism.
Three cohorts of 8 male volunteers each will be tested, with single ascending doses at the Medical University of Vienna. The principal investigator will be Dr. Markus Müller, Department of Clinical Pharmacology at the Medical University of Vienna. Cosmo will manufacture the cream at its GMP approved facilities in Lainate, Milan, Italy.
Anti-androgens are known to be effective in controlling acne, androgenetic alopecia (androgen-induced male baldness), and hirsutism (androgen-induced facial and body hair growth in females) but, when systemically applied, they can detrimentally affect the sex life of patients. Pre-clinical studies have shown that CB-03-01 could be as active as currently marketed treatments but devoid of common systemic effects since, once absorbed, it is rapidly metabolised to a physiological substance lacking anti-androgen activity.
Commenting on today’s announcement, Mauro Ajani, CEO of Cosmo, said: “CB-03-01 is the first new chemical entity that Cosmo is developing and the only product so far that is not based on our innovative MMX™ technology. It is one of more than 20 molecules originally identified and patented by Cosmo. We are delighted to be working on this trial with the University of Vienna, which is known for its excellence in skin related diseases. CB-03-01 has the potential to be the first topically effective anti-androgen treatment on the market.”
About acne, alopecia and hirsutism Acne affects about 45 million people in the USA ie around 16% of the population. The world wide market for acne is presumed at more than $ 2.8 billion. Roaccutane™ of Roche had sales exceeding $ 253 million in 2004 but these decreased following FDA warning for side effects.
Alopecia (androgen induced hair loss in males) affects about 12% of all men over 20 years of age. Propecia™ (Merck), a systemically applied drug, had sales of $ 405 million in 2007.
Hirsutism (androgen induced growth of facial and/or body hair in women) affects about 10% of the female population. The world wide market remains largely undeveloped.
About Cosmo Pharmaceuticals Cosmo is a speciality pharma company that aims to become a global leader in optimised therapies for certain gastrointestinal diseases. The company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as ulcerative colitis and Crohn’s disease, and colon infections. Cosmo’s first product is LIALDA™ / MEZAVANT™ that is licensed globally to Giuliani and Shire Pharmaceuticals. Cosmo’s proprietary MMX™ technology is at the core of the company’s product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. For further information on Cosmo, please visit the Company’s website: www.cosmopharmaceuticals.com
For more information please contact: Dr. Chris Tanner, CFO and Head of Investor Relations Cosmo Pharmaceuticals Tel: +39 02 9333 7614 Fax: +39 02 9333 7663 E-mail: chris.tanner@cosmopharmaceuticals.com
