(BFM Bourse) – The group has received a complaint from Health Canada, the Canadian health authority, in connection with the marketing authorization application for mastinib for the treatment of amyotrophic lateral sclerosis, also known as Charcot’s disease.

AB Science may be hoping to get a major regulatory green light for its flagship molecule, mastinib, later this year. This will not be the case.

Founded in 2001 and publicly listed in 2010, the biotechnology company was awaiting approval from Health Canada later this year. This authority checked since last May Mastinib, used to treat amyotrophic lateral sclerosis (ALS, also known as Charcot’s disease) in an accelerated procedure known as ‘NO/c’.

ALS is characterized by the degeneration and death of certain motor neurons, which stop sending messages to muscles, causing progressive paralysis. It causes the death of the patient after a period of 3 to 5 years. Its prevalence in western countries is about 6 per 100,000 people, which equates to about 30,000 cases in Europe and 20,000 in the United States.

90 days to reply

AB Science announced Tuesday night that Health Canada has received a notification of defects (“NOD”) on this regulatory submission for the treatment of ALS.

This notice of deficiency means that the Canadian health authority has asked AB Science the submission of additional information as part of this request. Logically, Health Canada stopped reviewing mastinib.

The company now has 90 days to respond to Health Canada’s notice of defects. “AB Science will be reaching out to Health Canada to respond to the agency’s objections with the intention of resuming the record review process within the allotted time,” the company said in a statement.

“Note that this is not a refusal, which would take the form of a notice of non-compliance (NON) in the event a file is deemed incomplete or non-compliant. At this stage examination of the fileAB Science is therefore ongoing,” notes Invest Securities.

A demand in Europe

These strange investors are taking hold of the Paris Stock Exchange. The title AB Science tumbled 32% around 10:20 a.m., posting the largest drop in the entire B division of the Paris Stock Exchange. This increases the value losses over the entire year 2022 to almost 50%, with a capitalization of 284 million euros.

In addition to the priority review in Canada, AB Science Submitted at the end of August an approval request for mastinib in the treatment of ALS by the European Medicines Agency (EMA). The application has been validated and the review of the dossier by the EMA’s Committee for Medicinal Products for Human Use is due to issue an opinion within 210 days, ie a priori towards the end of March.

The biotech has also received approval from several health authorities to initiate a Phase III study (final phase of clinical trials before possible commercialization) aimed at evaluating mastinib for the treatment of Alzheimer’s disease. MastinibAB Science has already been registered in veterinary medicine in Europe and the United States.

Julien Marion – ©2022 BFM Stock Exchange