AB Science announces issuance of a European patent for masitinib in the treatment of severe mastocytosis with protection until 2036

PRESS RELEASE

AB SCIENCE ANNOUNCES ISSUANCE OF A EUROPEAN PATENT FOR MASITINIB IN THE TREATMENT OF SEVERE MASTOCYTOSIS WITH PROTECTION UNTIL 2036

Paris, May 13, 2024, 6pm CET

AB Science SA (Euronext - FR0010557264 - AB) today announced that the European patent office has issued a Grant Decision for a patent relating to methods of treating severe mastocytosis with its lead compound masitinib (patent EP 3359195A1). This new European patent provides intellectual property (IP) protection for masitinib in this indication until October 2036 and adds to IP coverage already granted in the USA (US 10045978B2) and Japan (JP 6801892B2).

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. 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.

Masitinib has also received orphan drug designation for mastocytosis from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). This orphan drug designation provides 10 and 7 years of market exclusivity in Europe and the United States respectively, subsequent to product approval.

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.

Reference

[1] Lortholary O, Chandesris MO, Bulai Livideanu C, et al. Masitinib for treatment of severely symptomatic indolent systemic mastocytosis: a randomised, placebo-controlled, phase 3 study. Lancet. 2017;389(10069):612-620.

About Indolent Systemic Mastocytosis
Indolent systemic mastocytosis (ISM) is a hematological disease characterized by an abnormal number and activation of mast cells in the bone marrow and other organs. The disease if characterized by multiple symptoms that are disabling and can in some cases be life-threatening. Symptoms associated ISM are predominantly associated with neurological disorders (depression, fatigue, cognitive impairment, headache), skin disorders (pruritus, skin lesions), flushing and gastro-intestinal disorders. ISM affects approximately 40,000 people in Europe and 25,000 in the USA. There is currently a high unmet medical need in this population.