Paris, 4 July 2016, 5:45 pm
Review of the conditional marketing authorization application of masitinib in amyotrophic lateral sclerosis (ALS) will follow the standard timeline of the European Medicines Agency (EMA)
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specialized in the research, development and marketing of protein kinase inhibitors (PKIs), announced today that the Committee for Medicinal Products for Human Use (CHMP) did not recommend at this time the accelerated assessment and therefore the review of the conditional marketing authorization application of masitinib in amyotrophic lateral sclerosis (ALS) will follow the standard timeline of the European Medicines Agency (EMA).
This request for filing was based on clinical data from the phase 2/3 study AB10015, which was successful on its pre-specified primary endpoint at the interim analysis (192 patients). The study continues blinded in order to generate additional data based on the 394 patients enrolled in the study.
Although the CHMP recognized that the need in ALS, which is a serious and life threatening disease, fits the requirement for accelerated approval, the CHMP considered that, if the application was reviewed under accelerated assessment, it was not certain that AB Science would be able to provide the final data of the phase 2/3 study AB10015 at the time of the CHMP decision.
As a reminder, the interim analysis results of study AB10015 were known in April 2016. The filing of the application for conditional marketing authorization is planned toward the end of Q3 2016, and the final results of study AB10015 should be available to AB Science by the end of Q1 2017.
Under accelerated assessment procedure, the CHMP should adopt a decision between 90 days at minimum and 180 days at maximum, including one month of clock-stop that the sponsor must respect to respond to the agency questions. Therefore, with a filing in September 2016, the CHMP vote would have likely occurred at the latest in March 2017. By contrast, the assessment period under standard procedure is 210 days plus the time of clock-stops where sponsor has to respond to the agency questions. Therefore, under standard timeline, the CHMP vote will likely occur in Q3 2017 after the final data of the phase 2/3 study AB10015 are available.
The CHMP also indicated that a review under accelerated assessment may be reconsidered once the final data are available.
About masitinib
Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, important cells for immunity, through inhibiting a limited number of kinases. Based on its unique 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. In oncology due to its immunotherapy effect, masitinib can have an effect on survival, alone or in combination with chemotherapy. Through its activity on mast cells and microglia and consequently the inhibition of the activation of the inflammatory process, masitinib can have an effect on the symptoms associated with some inflammatory and central nervous system diseases and the degeneration of these diseases.
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 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 twelve 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, 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).
Further information is available on AB Science website: http://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.
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