Acasti Pharma Awarded Notice of Allowance for Additional Composition of Matter and Method of Use Patents in the United States...
March 11 2020 - 8:00AM
Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST –
TSX-V: ACST), a biopharmaceutical innovator focused on the
research, development and commercialization of its
prescription drug candidate CaPre® (omega-3 phospholipid) for the
treatment of severe hypertriglyceridemia, today announced that it
has received a Notice of Allowance for an additional composition of
matter and method of use patent from the US Patent and Trademark
Office (USPTO), the 4th patent to be awarded in the U.S., and a
Notice of Allowance for a composition of matter and method of use
patent awarded by the Mexican Patent Office, the 3rd patent to be
awarded in Mexico. These new patents broaden the Company’s
existing claims to include any composition containing EPA and DHA
where at least 50% of the composition consists of phospholipids.
These new patents further strengthen the intellectual property
position of CaPre. In addition, Acasti also received a favorable
decision issued by the Japan Patent Office following an opposition
proceeding filed by a third party against its divisional
application, confirming its validity. This decision resulted in the
allowance of Acasti’s second major patent in Japan.
“The United States and Mexico represent
important markets for Acasti, given the high prevalence of
hypertriglyceridemia and the need for an effective, safe and
well-absorbing omega-3 therapeutic for the treatment of
cardiovascular-related diseases. Furthermore, these patents
strengthen the Company’s strategic position in these important
markets, which could support valuable commercial opportunities in
the future. In addition, Acasti’s success in upholding its patent
in Japan is a yet another confirmation of the strength of our
claims and IP portfolio,” said Pierre Lemieux, PhD, Acasti's Chief
Operating Officer and Chief Scientific Officer.
Jan D’Alvise, president and CEO of Acasti
Pharma, commented, “We have completed the clinical site and central
lab audits of the TRILOGY 1 data, including additional post-hoc
analyses. As a result, I am pleased to report that we now
expect to submit our FDA meeting request by the end of March. We
look forward to reporting further developments, including an update
on a meeting date as soon as it has been set.”
About CaPre (omega-3
phospholipid)
Acasti’s prescription drug candidate, CaPre, is a highly
purified omega-3 phospholipid concentrate derived from krill oil,
and is being developed to treat severe hypertriglyceridemia, a
metabolic condition that contributes to increased risk of
cardiovascular disease and pancreatitis. Its omega-3s, principally
EPA and DHA, are either “free” or bound to phospholipids, which
allows for better absorption into the body. Acasti believes that
EPA and DHA are more efficiently
transported by phospholipids sourced from krill oil than the EPA
and DHA contained in fish oil that are transported either by
triglycerides (as in dietary supplements) or as ethyl esters in
other prescription omega-3 drugs, which must then undergo
additional digestion before they are ready for transport in the
bloodstream. Clinically, the phospholipids may not only improve the
absorption, distribution, and metabolism of omega-3s, but they may
also decrease the synthesis of LDL cholesterol in the liver, impede
or block cholesterol absorption, and stimulate lipid secretion from
bile. In two Phase 2 studies, CaPre achieved a statistically
significant reduction of triglycerides and non-HDL cholesterol
levels in patients across the dyslipidemia spectrum from patients
with mild to moderate hypertriglyceridemia (patients with TG blood
levels between 200mg/dl and 500mg/dl) to patients with severe
hypertriglyceridemia (those with TG levels above 500mg/dl).
Furthermore, in the Phase 2 studies, CaPre demonstrated the
potential to actually reduce LDL, or “bad cholesterol”, as well as
the potential to increase HDL, or “good cholesterol”, especially at
the therapeutic dose of 4 grams/day. The Phase 2 data also showed a
significant reduction of HbA1c at a 4 gram dose, suggesting that
due to its unique omega-3/phospholipid composition, CaPre may
actually improve long-term glucose metabolism. Acasti’s TRILOGY
Phase 3 program is currently underway.
About Acasti Pharma
Acasti is a biopharmaceutical innovator advancing a potentially
best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid),
for the treatment of hypertriglyceridemia, a chronic condition
affecting an estimated one third of the
U.S. population. Since its founding in 2008,
Acasti has focused on addressing a critical market need for an
effective, safe and well-absorbing omega-3 therapeutic that can
make a positive impact on the major blood lipids associated with
cardiovascular disease risk. The Company is developing CaPre in a
Phase 3 clinical program in patients with severe
hypertriglyceridemia, a market that includes 3 to 4 million
patients in the U.S. The addressable market may expand
significantly if omega-3s demonstrate long-term cardiovascular
benefits in on-going outcomes studies (REDUCE-IT and STRENGTH).
Acasti may need to conduct at least one additional clinical trial
to expand CaPre’s indications to this segment. Acasti’s strategy is
to commercialize CaPre in the U.S. and the Company is pursuing
development and distribution partnerships to market CaPre in major
countries around the world. For more information, visit
www.acastipharma.com.
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 U.S. federal
securities laws (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 labeled with the terms “believes,” “belief,”
“expects,” “intends,” “anticipates,” “potential,”
“should,” “may,” “will,” “plans,” “continue” 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.
Forward-looking statements in this press release include, but are
not limited to, information or statements about Acasti’s strategy,
future operations, prospects and the plans of management; Acasti’s
ability to conduct all required clinical and non-clinical trials
for CaPre, including the timing and results of those trials; and
CaPre’s potential to become the “best-in-class” cardiovascular drug
for treating severe Hypertriglyceridemia (HTG).
The forward-looking statements contained in this
press release are expressly qualified in their entirety by this
cautionary statement, the “Cautionary Note Regarding
Forward-Looking Information” section contained in Acasti’s latest
annual report on Form 20-F and most recent management’s discussion
and analysis (MD&A), which are available on SEDAR at
www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, and on the
investor section of Acasti’s website at www.acastipharma.com. All
forward-looking statements in this press release are made as of the
date of this press release. Acasti does not undertake to update any
such forward-looking statements whether as a result of new
information, future events or otherwise, except as required by law.
The forward-looking statements contained herein are also subject
generally to assumptions and risks and uncertainties that are
described from time to time in Acasti’s public securities
filings with the Securities and Exchange Commission and
the Canadian securities commissions, including Acasti’s
latest annual report on Form 20-F and most recent MD&A.
Neither NASDAQ, the TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Acasti Contact:Jan
D’AlviseChief Executive OfficerTel: 450-686-4555Email:
info@acastipharma.com www.acastipharma.com
Investor
Contact:Crescendo
Communications, LLCTel: 212-671-1020Email:
ACST@crescendo-ir.com
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