Acasti Pharma Awarded Notice of Allowance for a Second Patent in China Covering CaPre’s Omega-3 Phospholipid Composition
June 24 2019 - 9:00AM
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 its second patent to be awarded in the
People’s Republic of China. This new patent expands the
Company’s existing claims, and is valid until 2030. The new
patent relates to concentrated therapeutic omega-3 phospholipid
compositions, and covers certain methods for the treatment and
prevention of cardiovascular diseases, metabolic syndrome,
inflammation, neurodevelopmental and neurodegenerative diseases.
"Today's announcement further strengthens and
expands our intellectual property portfolio by giving us protection
in a very large, emerging and important market, and it creates
potential expansion opportunities for additional Acasti products
going forward," said Pierre Lemieux, PhD, Acasti's Chief Operating
Officer and Chief Scientific Officer. "There currently are no
approved omega-3 drugs available in China, creating an opportunity
for a high-quality, well-studied and differentiated product like
CaPre. China is the third largest pharmaceutical market in the
world, with an average compounded annual sales growth rate of
approximately 20% over the past ten years."
Brian Groch, Chief Commercial Officer of Acasti,
commented, “China represents an important market for Acasti, given
the high prevalence of hypertriglyceridemia and the need for an
effective, safe and efficiently absorbed drug for the treatment of
cardiometabolic related diseases. The timing of this patent
is ideal as we near completion of the TRILOGY Phase 3 clinical
trials for CaPre and prepare for commercialization. This patent
broadens our previously allowed claims in China, and provides us
with solid, long-term protection there. This patent also builds
upon similar patents we have been awarded around the world.”
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’Alvise Chief Executive Officer Tel: 450-686-4555Email:
info@acastipharma.com www.acastipharma.com
U.S. Contact:
David WaldmanPresidentCrescendo Communications, LLC Tel:
212-671-1020Email: ACST@crescendo-ir.com
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