AB Science SA announced that the patent office of Japan has issued a Notice of Allowance (NOA) for a patent relating to methods of treating amyotrophic lateral sclerosis (ALS) with its lead compound masitinib (JP 2022037132A). As a result, intellectual property protection for masitinib is secured in ALS until 2037. This NOA follows patent protection previously granted in other major international markets, including Europe (patent EP 3240538), USA (US 10092564), China (ZL201780019760.9), South Korea (KR 10-2293847), Israel (IL 261856), Australia (AU M53001274), Eurasia (EA 201800499), Mexico (MX 390495), Singapore (SG 11201808106Y), New Zealand (NZ 745778), and South Africa (ZA 2018/05810).

An NOA is issued after an examiner determines that a patent application satisfies all requirements for patentability. This newly issued patent further enhances the Company's key patent family for masitinib, which includes U.S. patents US7423055B2, US8835435B2, US8993573B2, US8153792B2 and US20100093750A1 (as well as their foreign counterparts). More specifically, this patent provides broad protection of masitinib and related compounds of its class for treatment of ALS in a patient subpopulation initially selected for treatment based on disease aggressiveness (as measured by functional progression rate).

This patient population is fully consistent with the clinical development program of masitinib in ALS (study AB10015) including the ongoing international phase 3 randomized clinical trial (AB19001). Masitinib has also received orphan drug designation for ALS 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.