Neptune Technologies & Bioressources Inc. Enters Pharmaceutical Market With Onemia(TM) Launch by Acasti Pharma Inc.
October 25 2010 - 6:00AM
Neptune Technologies & Bioressources Inc. ("Neptune")
(Nasdaq:NEPT) (TSX-V:NTB) enters the pharmaceutical market
with the launch of Onemia™, the first medical food of Neptune's
subsidiary Acasti Pharma Inc. ("Acasti"). Only two years since its
foundation, Acasti has completed the development and launch of
"Onemia™" on October 21, 2010 at the Cardiometabolic Health
Congress meeting in Boston.
Onemia™ is a pharmaceutical marine-based omega-3 phospholipid
concentrate classified as a novel medical food, regulated by FDA
and clinically proven safe and effective for the management of
unmet medical needs associated with chronic cardiometabolic
disorders. As a medical food, it is intended to fulfill the unique
omega-3 and phospholipid requirements of illnesses associated with
cardiometabolic disorders.
Onemia™ will be formulated in a hard gelatin capsule to be taken
alone or in combination with currently approved and prescribed
cardiovascular drugs administered only under physician supervision
and dispensed by medical recommendation and in some cases by
prescription, in compliance with applicable FDA regulations.
Onemia™ will be manufactured by Neptune and sold to Acasti.
Onemia™ targets cardiometabolic disorders and will be well
positioned in this multibillion dollar market. Onemia™ will first
be distributed through a unique subcontracted marketing and direct
sale approach focused in most major metropolitan areas in the U.S.
and move nationwide in a second phase. Onemia™ will later be
available in pharmacies behind-the-counter through distributors.
Acasti is also currently seeking partners to commercialize Onemia™
outside the United States.
Cardiometabolic disorders are considered among the leading
health problems worldwide arising from the combined impact of
obesity and cardiovascular disease. According to the American
Heart Association 2006 to 2010 statistical fact sheets updates, 102
million Americans have been diagnosed with hyperlipidemia, 34
million with low HDL (good cholesterol), 17 million with coronary
artery disease and 145 million are overweight or obese. Amongst
others, these cardiometabolic risk factors lead to 1.2 million new
myocardial infarctions diagnosed each year of which only 1 of 3
survive. According to the 2009 Heart Disease and Stroke Statistics
Update, the estimated direct and indirect costs of cardiovascular
disease and stroke in the United States totaled USD 475 billion of
which, USD 52 billion was spent only on medications.
"With the launch of Onemia™ both Neptune and Acasti enter the
pharmaceutical arena directly through physicians who will recommend
it for the therapeutic management of chronic illnesses/conditions.
Acasti will now work with physicians through an outsourced task
force facilitating the supply of Onemia™ directly to the patients
via online pharmacy outlets based in the United States," said
Pierre Lemieux, Ph.D., C.O.O. of Acasti.
"Acasti`s continuous achievements including the present launch
of its first medical food will instigate the exercise of actual
outstanding warrants which, as initially planned, will contribute
to the Company`s financial requirements along with the early
revenues earned from the commercialization of its pharmaceuticals,
starting with Onemia™," said Xavier Harland, CFA, Financial
Director of Acasti.
"True to our initial strategy Acasti has met yet another pivotal
milestone with the timely launch of our first medical food in the
pharmaceutical market. The success of Onemia™ will provide
short-term revenues which will contribute to Acasti's further
research and development projects while establishing a validation
of Acasti's omega-3:phospholipid pipeline in the healthcare
industry paving the road for CaPre™, our prescription drug
candidate in development," declared Tina Sampalis, M.D., Ph.D.,
President. "Contrary to the usual biotechnology constant need for
external financing imposed by drug development, Acasti intends to
self-finance a substantial part of its internal operations and
R&D expenditures by early commercialization of its medical food
and fixed dose combination over the counter products in partnership
with major pharmaceutical companies. Onemia™ is the first of a line
of products Acasti will commercialize in the near future," she
added.
About Medical Foods
As per FDA's 1988 Orphan Drug Act amendments, a Medical Food is
a regulated product, in a relatively new category of medical
protocols defined by US Congress. A Medical Food is formulated to
be consumed or administered entirely under the supervision of a
Physician and is intended for the specific dietary management of a
disease or condition for which distinctive nutritional
requirements, based on recognized scientific principles, are
established by medical evaluation. Medical Foods can be
prescription products, but are different than drugs or dietary
supplements (also called nutraceuticals) in several aspects, such
as their claims. Claims for both Medical Foods and drugs must be
supported by solid laboratory and clinical data. Medical Food
ingredients have GRAS designation, the highest FDA standard of
safety given to foods. Medical Foods, sometimes prescribed in
addition to drugs, nonetheless represent an entirely different
scientific and medical approach to managing diseases.
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.
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.
"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: Neptune Technologies & Bioressources Inc.
Andre Godin, V.P. Administration and Finance
+1 450.687.2262
a.godin@neptunebiotech.com
www.neptunebiotech.com
Acasti Pharma
Tina Sampalis, President
+1 450.686.4555 (ext: 403)
t.sampalis@acastipharma.com
www.acastipharma.com
Howard Group
Bob Beaty
+1 403.410.6020
bob@howardgroupinc.com
www.howardgroupinc.com
CEOcast
Dan Schustack
+1 212.732.4300
dschustack@ceocast.com
www.ceocast.com
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