Neptune Technologies & Bioressources Inc. Reports Completion of Acasti Pharma Comparative Benchmarking Program Versus Lovaza(R)
2010年11月25日 - 10:30PM
Neptune Technologies & Bioressources Inc. ("Neptune")
(Nasdaq:NEPT) (TSX-V:NTB) subsidiary, Acasti Pharma Inc.
("Acasti"), reports the completion of its preclinical program
designed to compare the lipid management effects of Acasti's drug
candidate CaPre™ versus prescription drug Lovaza®. Blood
lipids were monitored in two animal models in order to assess and
compare the efficacy of CaPre™ and Lovaza® over a 12-week treatment
period.
- A low daily human equivalent dose of 1g CaPre™ reduced LDL-C
(bad cholesterol) levels by 40% and increased HDL-C (good
cholesterol) by 180% in a normal rat model ("SD") while 4gr of
Lovaza® did not show any significant effect.
- An even lower daily human equivalent dose of 0.5g CaPre™ was
shown to be as efficient as 4g of Lovaza® in reducing triglycerides
levels by 40-50% in obese rats with severe diabetes and high
triglycerides ("ZDF")
"These results suggest that a low (0.5g to 1g) daily dosing of
CaPre™ is more effective than 4g Lovaza® in elevating HDL-C and
lowering LDL-C and triglycerides. These effects become even
more striking considering that a 1g daily dose of CaPre™ contains
8.9 times less EPA and 11.1 times less DHA than the recommended 4g
daily dose of Lovaza®. It is also important to note that the
triglycerides reduction was observed only after 4 weeks and was
maintained throughout the study suggesting a significant metabolic
impact of CaPre™," said Dr. Bruno Battistini, Senior Director,
Pharmaceutical R&D of Acasti.
"Taken together, the present and previously disclosed data
suggest that CaPre™ may be an effective alternative for the
management of cardiometabolic disorders due to its therapeutic
versatility and multiple applications including also a superiority
over Lovaza® on Omegas-3 Index and impaired glucose
tolerance. This difference in activity is likely to be
explained by the fact that phospholipids functionalize the omega-3
(EPA and DHA) contained in CaPre™ versus omega-3-acid ethyl ester
in Lovaza®," said Pierre Lemieux, Ph.D., COO of
Acasti. "According to market research firm IMS Health, global
sales of Lovaza® topped $1 billion in 2009, with $758 million of
those sales originating in the U.S. Moreover, in 2007,
GlaxoSmithKline PLC (LSE/NYSE:GSK) acquired the USA rights to
Lovaza® by its acquisition of Reliant Pharmaceuticals Inc. for
$1.65 billion, which is an indicator of the potential value of
CaPre™," he added.
"To be able to benchmark against a formulation such as Lovaza®,
being the only FDA approved "prescription omega-3 fish oil" solely
indicated for the treatment of severe hypertriglyceridemia (very
high triglycerides >500mg/dl) along with a healthy diet that has
now reached over 1B$ in sales, is encouraging. We believe that
CaPre™ is in a much better position to improve the compliance of
patients and help the treating physician. This latest
benchmarking program gives us a great deal of confidence regarding
the upcoming phase II clinical trial for which we recently
submitted a Clinical Trial Application in Canada," said Dr. Tina
Sampalis, President of Acasti.
About the animal models
Adult male ZDF and SD rats were treated once-a-day with either
CaPre™, Lovaza® or placebo. Blood lipids (TGs, LDL-C, HDL-C) were
measured using standard clinical chemistry by an independent
laboratory. The Zucker Diabetic Fatty (ZDF) rat on a high-fat
diet is a well-accepted model of cardiometabolic disorder routinely
used to specifically evaluate the efficacy of active pharmaceutical
ingredients on high triglycerides (TGs) and diabetes.
Sprague-Dawley (SD) rats fed a normal diet were used to compare the
effect of both omega-3 distinct formulations over bad (LDL) and
good (HDL) cholesterol.
About Neptune Technologies & Bioressources
Inc.
Neptune 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.
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, 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 NeuroBioPharm Inc.
NeuroBioPharm is pursuing pharmaceutical neurological
applications, and a clinical study for a medical food product with
a multinational partner is already initiated. The development of a
prescription drug candidate is currently in progress. Advanced
clinical development and commercialization is planned to be carried
out with multinational partners.
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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
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CONTACT: Neptune Technologies & Bioressources Inc.
Andre Godin, V.P. Administration and Finance
+1 (450) 687-2262
a.godin@neptunebiotech.com
www.neptunebiotech.com
Acasti Pharma Inc.
Tina Sampalis, President
+1 (450) 686-4555
t.sampalis@acastipharma.com
www.acastipharma.com
CEOcast
Dan Schustack
+1 (212) 732-4300
dschustack@ceocast.com
www.ceocast.com
Howard Group
Bob Beaty
1 (888) 221-0915
bob@howardgroupinc.com
www.howardgroupinc.com
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