Action Plan Following Warning Letter by FDA

OREANDA-NEWS. AB Science SA, a pharmaceutical company specialized in the research, development and marketing of protein kinase inhibitors (PKIs), announces that the FDA informed AB Science that it trusts the action plan implemented to address the FDA warning letter and to comply with FDA regulations.

AB Science had received on June 16^th 2015 a warning letter from the FDA following the inspection by this health authority of the monitoring of completed studies (refer to AB Science press release dated 14 July 2015).

AB Science responded in July 2015 to this warning letter with a proposed thorough corrective and preventive action plan.

The FDA reviewed this plan and has now responded to AB Science. In its letter, the FDA stated that "We trust that the actions described in your letter will provide adequate measures to bring AB Science into compliance with FDA regulations".

Alain Moussy, CEO of AB Science, said "This letter is an important operational and regulatory milestone vis-?-vis FDA. We are pleased to have received two positive news from the FDA recently. First we received the authorization of compassionate use of masitinib in Amyotrophic Lateral Sclerosis. Second, we received statement from FDA that it trusts AB Science complies with FDA regulation".

Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a  class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment in cancers, inflammatory diseases, and central nervous system diseases, both in humans and animal health.

AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine in Europe and in the USA. The company is currently pursuing thirteen phase 3 studies in human medicine in first-line and second-line GIST, metastatic melanoma expressing JM mutation of c-Kit, multiple myeloma, metastatic colorectal cancer, metastatic prostate cancer, pancreatic cancer, T-cell lymphoma, mastocytosis, severe asthma uncontrolled by oral corticosteroid, Alzheimer's disease, progressive forms of multiple sclerosis, and amyotrophic lateral sclerosis. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).