AB Science confirms the filing for the Marketing Authorization Application to the European Medicines Agency of Masitinib in the treatment of Pancreatic Cancer

Tue Oct 16, 2012 12:15pm EDT

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AB Science confirms the filing for the Marketing Authorization Application to the European Medicines Agency of Masitinib in the treatment of Pancreatic Cancer

Regulatory News:

AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), confirms the filing to EMA for the Marketing Authorization Application for masitinib in the treatment of pancreatic cancer.

AB Science indicates that the communication of the results was delayed to allow the filing for patent applications aiming at extending the period of marketing exclusivity of masitinib in case of commercialization in this indication.

About pancreatic cancer

Pancreatic cancer is an aggressive cancer with poor prognosis. The survival rate after 5 years is only 5%. The incidence of this cancer represents about 110,000 new cases per year in industrialized countries. The global therapeutics market for pancreatic cancer is valued at $1200m in 2015.

About masitinib

Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells, important cells for immunity, as well as a limited number of kinases that play key roles in various cancers. Owing to its novel mechanism of action, masitinib can be developed in a large number of conditions in oncology, in inflammatory diseases and in certain diseases of the central nervous system. Through its activity of inhibiting certain kinases that are essential in some oncogenic processes, masitinib may have an effect on tumor regression, alone or in combination with chemotherapy. Through its activity on the mast cell and certain kinases essential to the activation of the inflammatory cells and fibrosing tissue remodeling, masitinib can have an effect on the symptoms associated with some inflammatory and central nervous system diseases.

Masitinib received orphan drug designation in the treatment of GIST from both FDA and EMA.

About AB Science

Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a new class of targeted molecules whose action is to modify signaling pathways within cells. Through these PKIs, the Company targets diseases with high unmet medical needs (cancer, inflammatory diseases and central nervous system diseases), in both human and veterinary medicines. AB Science has developed a proprietary portfolio of molecules and the Company’s lead compound,

Masitinib, has already been registered in veterinary medicine in Europe and in the USA, and is pursuing 10 phase 3 studies in human medicine – including 1 study under analysis in pancreatic cancer, and 8 on-going studies in GIST, metastatic melanoma expressing JM mutation of c-Kit, multiple myeloma, mastocytosis, severe persistent asthma, rheumatoid arthritis, and progressive multiple sclerosis. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).

Further information is available on AB Science’s website: www.ab-science.com

This document contains prospective information. No guarantee can be given as for the realization of these forecasts, which are subject to those risks described in documents deposited by the Company to the Authority of the financial markets, including trends of the economic conjuncture, the financial markets and the markets on which AB Science is present.

AB Science - Financial Communication & Press Relations
Laurent Guy, 01 47 20 00 14
investors@ab-science.com

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