NKO(R) is recognized as safe (GRAS) as a human food ingredient and meets
a required milestone for functional food partners and market entrance
LAVAL, QC, Jan. 23 /CNW Telbec/ - Neptune Technologies & Bioressources
Inc. ("Neptune") (NASDAQ.NEPT - TSX.V.NTB) received notification that Neptune
Krill Oil ("NKO(R)") has been determined to be safe as a human food
ingredient, a regulatory status required for the commercialization of NKO(R)
incorporated into different functional foods. Neptune has completed all the
necessary regulatory clearances for full commercialization in the United
A three-member panel of independent experts, Richard C. Kraska, Ph.D.,
DABT, Robert S. McQuate, Ph.D. and Stanley T. Omaye, Ph.D., with backgrounds
in toxicology, chemistry and pharmacology, performed an independent safety
evaluation of NKO(R). The review included an extensive package of safety,
toxicology and clinical research data obtained from animal and human testing.
In addition, information relating to the historic use of NKO(R) in food,
compositional details, specifications and method of preparation was submitted.
Dr. McQuate, CEO of GRAS Associates, indicated that the safety dossier
that has been generated by Neptune is impressive in its scientific rigor and
attention to critical details. The compositional characterization of the
proprietary krill oil is most impressive, and the analytical data were
carefully compared with other commonly consumed fish oils that are known to be
safe for human consumption. He added that additional support for NKO(R)'s GRAS
determination under the anticipated conditions of use was derived from
accompanying clinical and animal safety testing.
"Achieving GRAS notification within the target timeframe fulfills one
more milestone in Neptune's development program as well as a major requirement
of our partners in the food industry, Nestlé and Yoplait. GRAS approval is
another step leading to the commercialization of NKO(R) in the functional and
medical food markets," said Dr. Tina Sampalis, Chief Scientific Officer of
In accordance with FDA regulations, products must be generally recognized
as safe (GRAS) to be incorporated into foods. The authority to make novel GRAS
determinations is provided by independent experts who are qualified by
scientific training and experience to evaluate the safety of foods and food
ingredients under the intended conditions of use. Neptune has decided to
voluntarily submit the GRAS assessment document to the FDA which is, however,
not required for commercialization.
About Neptune Technologies & Bioressources Inc.
Neptune researches and develops proprietary bioactive ingredients and
products with nutraceutical, medical food and pharmaceutical applications.
Through clinical research, Neptune is showing the clinical benefits of its
products in various therapeutic indications with a focus on cardiovascular and
cognitive health. The Company has been successful in patenting and protecting
its intellectual property, and will continue to protect its innovations.
Neptune has already obtained regulatory approvals allowing commercialization
of its products and has filed for and is expecting additional approvals.
Neptune continues to strongly support its strategic development plan to
form partnerships/strategic alliances with worldwide leaders in the
nutraceutical and pharmaceutical industries. Neptune has recently signed
agreements with Nestlé and Yoplait, worldwide leading food manufacturers,
paving its entrance into the global functional food market. According to its
business strategy, negotiations with pharmaceutical companies with the
objective of entering the pharmaceutical market by licensing rights are
Important risk factors for cardiovascular disease are abnormal levels of
lipids such as triglycerides and cholesterol. Increased levels of low density
lipoprotein (LDL - "bad cholesterol") and decreased levels of high density
lipoprotein (HDL - "good cholesterol") promote plaque formation and
atherosclerosis potentially leading to heart attacks. Statins are commonly
used as the standard of care to decrease LDL. The $30 billion statin market
includes medications such as Lipitor(R), Zocor(R) and Crestor(R). However,
statins do not effectively address the unmet treatment need of raising HDL
resulting in a significant market opportunity for effective and safe regimens
such as offered by Neptune products.
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adequacy or accuracy of this press 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.
For further information:
For further information: Toni Rinow, Ph.D., MBA, Corporate Development &
Investor Relations, Neptune Technologies & Bioressources Inc., (450) 687-2262,
firstname.lastname@example.org, www.neptunebiotech.com; Source: Neptune
Technologies & Bioressources Inc.