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AB Science S.A. Announces European Marketing Authorization of Novel...



AB Science S.A., a biotechnology company that is focused on the development of novel and targeted drugs for cancer, inflammatory disease, and neurological disorders, today announced the recent achievement of two significant milestones. Last week, the European Commission granted a marketing authorization for AB Science'ss lead veterinary product masitinib (Masivet's174;). Separately, the company also recently formed a U.S. division, AB Science USA, in Short Hills, New Jersey.



The European marketing authorization follows the recommendation of the EMEA'ss Committee on Veterinary Medicinal Products (CVMP). The CVMP'ss recommendation was based on the quality, safety, and efficacy of clinical data showing that masitinib, a tyrosine kinase inhibitor, significantly extended survival in dogs with non-resectable mast cell tumors. In a multi-center, randomized, double-blind, placebo-controlled Phase III clinical field study of 202 dogs with grade II or III mast cell tumors, masitinib was well tolerated and significantly extended tumor time to progression (median survival time was 617 days versus 322 days on placebo).



Alain Moussy, president and CEO of AB Science S.A., commented, The authorization of Masivet in Europe represents a notable step toward our goal of launching the first cancer drug approved for veterinary use. Tyrosine kinase inhibitors such as masitinib have been shown to provide a safer, more effective, and more targeted alternative to the drugs that are currently used off label in veterinary oncology.



Masitinib is also under review for approval in the same indication by the FDA. In preparation for its U.S. launch under the trade name Kinavet's174;, AB Science launched the stateside division of its company in June 2008 under the leadership of Albert Ahn, D.V.M., president of U.S. operations. Having most recently served as senior director of veterinary services at Summit VetPharm, Dr. Ahn has also held several senior managerial positions at Sumitomo Corporation of America (formerly JW Childs), Merial (a division of Merck and Sanofi-Aventis), and Hill'ss Pet Nutrition, Inc. (a division of Colgate Palmolive).



As an experienced veterinarian and a seasoned industry veteran, Dr. Ahn is well equipped to handle our development and commercialization efforts in the U.S., said Moussy. We are delighted to have him on board.



I am very excited about the growing body of scientific data which is being developed by AB Science and its team of clinical researchers, said Dr. Ahn. Our company is dedicated to partnering with the veterinary profession to bring bold new innovations which will help address important needs in the areas of oncology and inflammatory diseases.



About AB Science S.A. and AB Science USA


Founded in Paris in 2001, AB Science S.A. is focused on the discovery and development of tyrosine kinase inhibitors for multiple high market-opportunity indications in animal and human medicine. By selectively targeting cell receptors known to be involved in various disease processes, tyrosine kinase inhibitors may provide safer and more effective treatments for a wide range of cancers, inflammatory diseases, and neurological indications. AB Science'ss lead drug candidate, masitinib, is currently under registration with the EMEA and the FDA for canine mast cell tumors, and it is also in Phase III development for canine inflammatory bowel disease. In human medicine, a European Phase II study showed masitinib to be a safe and effective treatment for mastocytosis, In 2009, AB Science will be conducting ten Phase II studies in colon cancer, prostate cancer, lung cancer, breast cancer, GIST, melanoma, interstitial cystitis, asthma, chronic obstructive pulmonary disease, multiple sclerosis, depression, pulmonary arterial hypertension, and muscular dystrophy as well as several early-stage and preclinical programs various oncology, inflammatory, and neurological indications. For more information, please visit http://www.ab-science.com.



Media Contact:


Meghan Feeks


(508) 274-1127


meghanfeeks@gmail.com



AB Science USA Contact:


Albert Ahn, D.V.M.


President, US Operations


51 JFK Parkway


First Floor West


Short Hills, New Jersey 07078


(973) 218-2437


albert.ahn@ab-science.com






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