PARIS, France – AB Science SA today announced that the European Patent Office has issued a Notice of Allowance for a patent relating to methods of treating severe systemic mastocytosis (i.e. a medical use patent) with its lead compound masitinib, based on findings from study AB06006. This new European patent provides intellectual property protection for masitinib in this indication until October 2036.
The same medical use patent strategy had been successfully pursued in amyotrophic lateral sclerosis, with patent granted worldwide until 2037, and is being pursued in other indications such as multiple sclerosis, Alzheimer’s disease for protection until 2041, and in prostate cancer until 2042.
Masitinib is positioned as a treatment of severely symptomatic systemic mastocytosis patients, including the subvariants of indolent and smoldering systemic mastocytosis, who are unresponsive to optimal symptomatic treatment.
The Notice of Allowance (NOA) means that the European Patent Office intends to grant the patent application, EP3359195A1, after the completion of certain formal procedural steps. Once granted, the patent can be kept in force until October 2036. A European NOA is issued after an examiner determines that a patent application satisfies all requirements for patentability under the European Patent Convention.
More specifically, this patent provides protection of masitinib and related compounds for treatment of systemic mastocytosis in a patient population presenting with at least two severe mast cell mediator release associated symptoms, selected from pruritus, flushes or depression (Hamilton rating scale). This patient population is consistent with results from masitinib study AB06006 [1] and also the on-going clinical development program of masitinib in severe systemic mastocytosis.
“This is good news because it proves once again that the masitinib platform is protected for a period of between 12 to 17 years depending on the indication, providing enough time to complete the program until registration and to maximize revenues during the commercialization phase”, said Alain Moussy, CEO of AB Science.
Masitinib has previously been granted orphan drug status in mastocytosis by the FDA and the EMA.
About masitinib
Masitinib is a 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.
AB Science has developed a proprietary portfolio of molecules and the Company’s lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases.
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