AB Science SA 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.

Mastocytosis: 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 and also the on-going clinical development program of masitinib in severe systemic mastocytosis.

Masitinib has previously been granted orphan drug status in mastocytosis by the FDA and the EMA.