Acasti Pharma Awarded Composition-of-Matter Patents for GTX-101 in Europe, China and Mexico and for GTX-102 in Japan
06 Octobre 2021 - 2:30PM
Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and
TSX-V: ACST), today announces that the European Patent Office,
Chinese Patent Office and the Mexican Patent Office have issued
composition of matter patents for GTX-101, a novel bio-adhesive
film forming topical spray formulation of bupivacaine for the
treatment of Postherpetic Neuralgia (PHN). PHN is a persistent and
often debilitating neuropathic pain caused by nerve damage from the
varicella zoster virus (shingles), which may persist for months and
even years. GTX-101 could provide significant benefits over the
current standard of care including greater convenience, faster
onset of action and longer duration of pain relief. The granted
patents are valid until 2036.
In addition, the Japanese Patent Office has
granted a composition of matter patent for GTX-102, a novel,
easy-to-use oral mucosal spray formulation of betamethasone,
intended to improve neurological symptoms of Ataxia-telangiectasia
(A-T). A-T is a progressive, neurodegenerative genetic disease that
primarily affects children causing severe physical disability, for
which no treatment currently exists. The granted patent is valid
until 2037.
Jan D’Alvise, Chief Executive Officer of Acasti,
stated, “These latest patents are important additions to our
intellectual property portfolio, expanding product protection to
additional important international markets as we continue to
progress these drug candidates through clinical studies. We believe
these granted composition of matter patents further support the
commercial potential of GTX-101 and GTX-102. Both drug candidates
have already received Orphan Drug Designation from the FDA and
could address important underserved global markets. The goal of
these proprietary formulations is to improve the quality of care
and patient outcomes by providing significant efficacy, safety and
convenience benefits including ease of use, faster onset of action
and extended relief.”
About Acasti
Acasti is a late-stage specialty pharma company
with drug delivery technologies and drug candidates addressing rare
and orphan diseases. Acasti’s novel drug delivery technologies have
the potential to improve the performance of currently marketed
drugs by achieving faster onset of action, enhanced efficacy,
reduced side effects, and more convenient drug delivery—all which
could help to increase treatment compliance and improve patient
outcomes.
Acasti’s three lead clinical assets have each
been granted Orphan Drug Designation by the FDA, which provide the
assets with seven years of marketing exclusivity post-launch in the
United States, and additional intellectual property protection with
over 40 granted and pending patents. Acasti’s lead clinical assets
target underserved orphan diseases: (i) GTX-104, an intravenous
infusion targeting Subarachnoid Hemorrhage (SAH), a rare and
life-threatening medical emergency in which bleeding occurs over
the surface of the brain in the subarachnoid space between the
brain and skull; (ii) GTX-102, an oral mucosal spray targeting
Ataxia-telangiectasia (A-T), a progressive, neurodegenerative
genetic disease that primarily affects children, causing severe
disability, and for which no treatment currently exists; and (iii)
GTX-101, a topical spray, targeting Postherpetic Neuralgia (PHN), a
persistent and often debilitating neuropathic pain caused by nerve
damage from the varicella zoster virus (shingles), which may
persist for months and even years. For more information, please
visit: https://www.acastipharma.com/en.
Forward-Looking Statements
Statements in this press release that are not
statements of historical or current fact constitute
“forward-looking information” within the meaning of Canadian
securities laws and “forward-looking statements” within the meaning
of the U.S. Private Securities Litigation Reform Act of 1995, as
amended, Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended
(collectively, “forward-looking statements”). Such forward looking
statements involve known and unknown risks, uncertainties, and
other unknown factors that could cause the actual results of Acasti
to be materially different from historical results or from any
future results expressed or implied by such forward-looking
statements. In addition to statements which explicitly describe
such risks and uncertainties, readers are urged to consider
statements containing the terms “believes,” “belief,” “expects,”
“intends,” “anticipates,” “potential,” “should,” “may,” “will,”
“plans,” “continue”, “targeted” or other similar expressions to be
uncertain and forward-looking. Readers are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date of this press release.
The forward-looking statements in this press
release are based upon Acasti’s current expectations and involve
assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties,
including, without limitation: (i) the success and timing of
regulatory submissions of the PK bridging study for GTX-104 and
Acasti’s other pre-clinical and clinical trials; (ii) regulatory
requirements or developments; (iii) changes to clinical trial
designs and regulatory pathways; (iv) legislative, regulatory,
political and economic developments, and (v) the effects of
COVID-19 on clinical programs and business operations. The
foregoing list of important factors that could cause actual events
to differ from expectations should not be construed as exhaustive
and should be read in conjunction with statements that are included
herein and elsewhere, including the risk factors detailed in
documents that have been and may be filed by Acasti from time to
time with the Securities and Exchange Commission. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Acasti undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date on which they were made,
except as required by applicable securities laws.
Neither NASDAQ, the TSXV nor its Regulation
Services Provider (as that term is defined in the policies of the
TSXV) accepts responsibility for the adequacy or accuracy of this
release.
Acasti Contact:Jan D’AlviseChief Executive
Officer Tel: 450-686-4555Email: info@acastipharma.com
www.acastipharma.com
Investor Contact:Crescendo
Communications, LLC Tel: 212-671-1020Email:
ACST@crescendo-ir.com
Media Contact :Jules AbrahamJQA Partners,
Inc.Tel: 917-885-7378Email: jabraham@jqapartners.com
Acasti Pharma (TSXV:ACST)
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