Acasti Pharma Inc. Receives Health Canada Clearance for an Open-Label Phase II Hypertriglyceridemia...

Mon Oct 17, 2011 8:03am EDT

* Reuters is not responsible for the content in this press release.

Acasti Pharma Inc. Receives Health Canada Clearance for an Open-Label Phase II
Hypertriglyceridemia Trial

LAVAL, Quebec, Oct. 17, 2011 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Acasti)
(TSX.V:APO), a subsidiary of Neptune Technologies & Bioressources Inc.
(Neptune), has received another positive response from Health Canada regarding
its second Clinical Trial Application (CTA), thereby allowing the initiation of
an open-label phase II clinical trial with CaPre(R).

Health Canada informed Acasti that there was no objection to Acasti's proposed
study based on the information and material provided to support the CTA.
Therefore, Acasti will initiate an open-label phase II human clinical trial to
investigate the dose response effect of CaPre(R) as a treatment for patients
with dyslipidemia. Enrollment in the study is expected to commence in the next
few weeks with results anticipated early 2012. The design of the study is an
open-label trial to assess the safety and efficacy of CaPre(R) in patients with
triglyceride levels ranging from moderately high to very high, which
distinguishes CaPre(R) from prescription drug fish oils labelled only to treat
patients with very high levels of triglycerides.

"We are pleased with Health Canada's authorization; it represents another
milestone in Acasti's clinical development plan towards positioning CaPre(R) as
a safe and efficacious first-in-class regimen to help manage cardiometabolic
disorders" indicated Pierre Lemieux, Ph.D., Chief Operating Officer.

"The ability to initiate this additional Phase II study allows Acasti to
generate near-term data to guide our regulatory and clinical strategy. We
believe the broad potential activity and safety of CaPre in the wider
dyslipidemic population will distinguish our drug from others in this arena.
This effort will also help form the basis of our future clinical work in the US
and Europe" said Harlan Waksal, M.D., Executive Vice President.

"Acasti has made significant progress over the last few months including this
CTA acceptance as well as the recently announced initiation of enrolment in our
first Phase II double-blind placebo controlled clinical trial. In addition to
our drug development initiatives, the composition of Acasti's active
pharmaceutical ingredients is now patented through Acasti's exclusive worldwide
license from Neptune Technologies and Bioressources. Neptune was recently
granted from the U.S. Patent and Trademark Office ("USPTO") a new patent (U.S.
No. 8,030,348) covering omega-3 phospholipids comprising polyunsaturated fatty
acids. Furthermore, Acasti recently completed the "Rights Offering" raising over
$8 million dollars" said Tina Sampalis, M.D., Ph.D., President.

About Acasti Pharma Inc.

Acasti (TSX-V:APO) 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, as
such, play 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 markets.

About Neptune Technologies & Bioressources Inc.

Neptune (Nasdaq:NEPT) and (TSX-V:NTB) is an industry-recognized leader in the
innovation, production and formulation of science-based and clinically proven
novel phospholipid products for the nutraceutical and pharmaceutical markets.
The Company focuses on growing consumer health markets including cardiovascular,
inflammatory and neurological diseases driven by consumers taking a more
proactive approach to managing health and preventing disease. The Company
sponsors clinical trials aimed to demonstrate its product health benefits and to
obtain regulatory approval for label health claims. Neptune is continuously
expanding its intellectual property portfolio as well as clinical studies and
regulatory approvals. Neptune's products are marketed and distributed in over 20
countries worldwide. Neptune is the mother company of Acasti and NeuroBioPharm.

"Neither Nasdaq nor 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."

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.

CONTACT:  Acasti Contact:
          Tina Sampalis
          President
          +1 450.686.4555
          t.sampalis@acastipharma.com 
          www.acastipharma.com 

          Xavier Harland
          Chief Financial Officer
          +1.450.687.2262
          x.harland@acastipharma.com
          www.acastipharma.com

          Howard Group Contact:
          Dave Burwell
          (888) 221-0915
          dave@howardgroupinc.com
          www.howardgroupinc.com
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