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: www.ab-science.com.
Forward-looking Statements - AB
Science
This press release contains forward-looking
statements. These statements are not historical facts. These
statements include projections and estimates as well as the
assumptions on which they are based, statements based on projects,
objectives, intentions and expectations regarding financial
results, events, operations, future services, product development
and their potential or future performance.
These forward-looking statements can often be
identified by the words "expect", "anticipate", "believe",
"intend", "estimate" or "plan" as well as other similar terms.
While AB Science believes these forward-looking statements are
reasonable, investors are cautioned that these forward-looking
statements are subject to numerous risks and uncertainties that are
difficult to predict and generally beyond the control of AB Science
and which may imply that results and actual events significantly
differ from those expressed, induced or anticipated in the
forward-looking information and statements. These risks and
uncertainties include the uncertainties related to product
development of the Company which may not be successful or to the
marketing authorizations granted by competent authorities or, more
generally, any factors that may affect marketing capacity of the
products developed by AB Science, as well as those developed or
identified in the public documents published by AB Science. AB
Science disclaims any obligation or undertaking to update the
forward-looking information and statements, subject to the
applicable regulations, in particular articles 223-1 et seq. of the
AMF General Regulations.
For additional information, please contact:
AB Science
Financial Communication & Media
Relations
investors@ab-science.com
Ab Science (LSE:0Q77)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
Ab Science (LSE:0Q77)
Gráfica de Acción Histórica
De May 2023 a May 2024