AB Science announces issuance of a Canadian patent for masitinib in the treatment of ALS with protection until 2037

PRESS RELEASE

AB SCIENCE ANNOUNCES ISSUANCE OF A CANADIAN PATENT FOR MASITINIB IN THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) WITH PROTECTION UNTIL 2037

CANADIAN PATENT COMPLETES INTELLECTUAL PROPERTY COVERAGE FOR ALS ACROSS ALL KEY GEOGRAPHIC AREAS WHERE MASITINIB COULD BE MARKETED, INCLUDING EUROPE, USA, CHINA, JAPAN AND SOUTH KOREA

Paris, 1st June, 2023, 6pm CET

AB Science SA (Euronext - FR0010557264 - AB) today announced that the patent office of Canada has issued a Notice of Allowance (NOA) for a patent relating to methods of treating amyotrophic lateral sclerosis (ALS) with its lead compound masitinib (CA 3018635).

This new Canadian patent provides strong protection for masitinib in the treatment of ALS until 2037 and completes the IP coverage for ALS across all key geographic areas where masitinib could be marketed, including Europe (patent EP 3240538), USA (US 10092564), China (ZL201780019760.9), South Korea (KR 10-2293847), Japan (JP 7250312B2), Singapore (SG 11201808106Y), Hong Kong (HK 1261581), Israel (IL 261856), Australia (AU M53001274), Eurasia (EA 201800499), Mexico (MX 390495), New Zealand (NZ 745778), and South Africa (ZA 2018/05810).

A NOA is issued after an examiner determines that a patent application satisfies all requirements for patentability. In addition to patent protection, masitinib is also eligible for regulatory data protection in Canada, preventing generic competition for a period of 8 years following initial approval.

As a reminder, Health Canada had granted authorization to file a new drug submission for masitinib in the treatment of ALS under the notice of compliance with conditions (NOC/c) policy. Market authorization under the NOC/c policy allows Health Canada to provide earlier market access to potentially life-saving drugs. NOC/c status is given to eligible drugs that have demonstrated promising clinical effectiveness in clinical trials. On May 9, 2023, AB Science announced that Health Canada had resumed its review of the application of masitinib in the treatment of ALS. Under the NOC/c policy, Health Canada has a target of 200 calendar days maximum to review the application.

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.

An estimated 3,000 Canadians are currently living with ALS. Each year approximately 1,000 Canadians die from ALS. A similar number of Canadians are diagnosed with ALS each year.

About amyotrophic lateral sclerosis

Amyotrophic lateral sclerosis (ALS) is a fatal motor neuron disorder that is characterized by progressive loss of the upper and lower motor neurons at the spinal or bulbar level. The disease belongs to a group of disorders known as motor neuron diseases, which are characterized by the gradual degeneration and death of motor neurons. In ALS, both the upper motor neurons and the lower motor neurons degenerate or die, and stop sending messages to muscles.

The prevalence of ALS in western countries is fairly uniform at 6 per 100,000 persons, corresponding to around 30,000 cases in Europe and 20,000 in the USA.

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. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).

Further information is available on AB Science’s website: .

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