LAVAL, QC, June 30 /CNW Telbec/ - Acasti Pharma Inc. ("Acasti") today
announced its financial results for the nine-month period ended February 28,
2009 (fiscal year end) and provides a scientific update.
"During the fiscal year, the Company has made significant progress in the
scientific research and development programs and has achieved several
value-creating milestones within the over-the-counter ("OTC"), medical food
and prescription drug programs," said Dr. Tina Sampalis, Acasti Pharma's
President. "Acasti's objective is to research, develop and license active
pharmaceutical ingredients designed to prevent and treat cardiovascular
disease," she added.
Update on recent Highlights
- Under the OTC program, product development has now been completed.
According to the strategic business development plan, negotiations with
prospective development partners are ongoing to evaluate a monotherapy
and two formulations.
- With regards to the medical food program, product development has been
completed and the Company has successfully obtained a positive review
from the Food and Drug Administration ("FDA") for medical food product
opportunities. The Company is discussing with potential partners in
order to evaluate customized formulations.
- Under the prescription drug development program, the product
development under Good Laboratory Practice ("GLP") has now been
completed for the prescription drug candidates. The Company has
received FDA guidance for an Investigational New Drug in the United
States and a Clinical Trial Application in Canada. The FDA approved the
general outline of the development plan and detailed protocols are in
preparation for submission. The Company has during its fiscal year,
initiated preclinical toxicity, dose response and efficacy studies in
animals required for regulatory submissions. Studies are progressing
according to timelines and budgets.
- In the nine-month period ended February 28, 2009, Acasti Pharma created
a loss of $782,000.
- At February 28, 2009, the Company had cash, cash equivalents and short-
term investments totaling $1,595,000 net of accounts payable to the
- Acasti Pharma is researching and developing novel active pharmaceutical
ingredients for cardiovascular applications and the expenses can be
mainly attributed to R&D expenses and administrative expenses,
initially and previously supported by the parent company Neptune
Technologies & Bioressources Inc.
Milestones Anticipated for 2009 and 2010
- Submission of a investigational new drug ("IND") application in the
United States with completed animal pharmacology and toxicology
studies, pharmacokinetics, mechanism of action, GMP chemistry,
manufacturing, control and proposed clinical protocols information.
- Submission of a clinical trial application ("CTA") in Canada required
for the initiation of clinical trials of experimental drug development.
- Partnership with a pharmaceutical company to evaluate over-the-counter
and/or medical food formulations.
(1) Please find complete financial information on www.sedar.com.
About Acasti Pharma Inc.
Acasti Pharma is developing a product portfolio of proprietary novel
long-chain omega-3 phospholipids. Phospholipids are the major component of
cell membranes and are essential for all vital cell processes. They are one of
the principal constituents of High Density Lipoprotein (good cholesterol) and
play, as such, an important role in modulating cholesterol efflux. Acasti
Pharma's proprietary novel phospholipids carry and functionalize the
polyunsaturated omega-3 fatty acids EPA and DHA, which have been shown to have
substantial health benefits and which are stabilized by potent antioxidants.
Acasti Pharma is focusing initially on treatments for chronic cardiovascular
conditions within the over-the-counter, medical food and prescription drug
Acasti Pharma is a subsidiary of Neptune Technologies & Bioressources
Inc. (NASDAQ: NEPT; TSX.V:NTB).
NASDAQ does not accept responsibility for the adequacy or accuracy of
this press release. Neither 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
Statements in this press release that are not statements of historical or
current fact constitute "forward-looking statements" within the meaning of the
U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities
laws. Such forward-looking statements involve known and unknown risks,
uncertainties, and other unknown factors that could cause the actual results
of the Company 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," "will," or "plans" to be
uncertain and forward-looking. The forward-looking statements contained herein
are also subject generally to other risks and uncertainties that are described
from time to time in the Company's reports filed with the Securities and
Exchange Commission and the Canadian securities commissions.
For further information:
For further information: Toni Rinow, Ph.D., MBA, Corporate Development &
Investor Relations, Acasti Pharma Inc., (450) 687-2262,