Enzymotec Ltd. Announces Positive Results Comparing Vayarol(R) to Ethyl Esters of Omega-3
April 30 2015 - 7:30AM
Enzymotec Ltd., (Nasdaq:ENZY) ("Enzymotec" or the "Company"), a
developer, manufacturer and marketer of innovative bio-active lipid
based nutritional ingredients and medical foods, announced today
that the Company had positive results from a clinical trial
comparing the effectiveness of Vayarol® versus Ethyl Esters of
Omega 3 ("EE," which are the active ingredients in a leading
brand), for the management of moderate levels of triglycerides.
"We are very excited to be able to announce the strong results
of this comparative study. The encouraging conclusions validate our
clinical trial work as we continue to grow the business. We look
forward to the opportunities that these positive results will
create for the Company," stated Rob Crim, CEO of VAYA Pharma, a
division of Enzymotec.
The 12 week double-blind controlled study was comprised of 201
randomized patients receiving either Vayarol®, a plant sterol ester
of Omega 3 consisting of 2.5g of phytosterols and 1.3g of Omega 3,
or Ethyl Esters of Omega 3 consisting of 3.11g of Omega 3. The
study met its primary endpoint as both Vayarol®and EE reduced
triglycerides levels with a similar efficacy that was within the
pre-defined range of the comparable margin. With a similar
triglyceride reduction profile, Vayarol® actually proves more
advantageous with half the Omega 3 concentration of EE. Vayarol®
also exhibited statistical significant superiority over EE with
respect to other lipid parameters, such as LDL cholesterol
("LDL-C"). Specifically, EE significantly increased LDL-C
while a decrease was observed with Vayarol®.
As demonstrated in past studies, the composition of Vayarol® was
well tolerated. There were no serious adverse events nor an
increase in side effects reported from either arm of the trial.
"These very strong results substantiate the simple and
effective use of Vayarol® as a medical food that contains omega 3
and phytosterols. Providing these two ingredients in a unique
composition displayed a reduction of triglycerides and the
prevention of LDL-C elevation, which is usually considered
inevitable with other Omega 3 preparations" stated Professor Ardon
Rubinstein, Principal Investigator and President of the Israeli
Diabetes Society.
"We are very pleased with the results of this comparative
study. The trial not only provides further support for Vayarol®'s
safety and efficacy profile but it also expanded our knowledge of
Vayarol®'s effect on hypertriglyceridemic patients," said Dr. Yael
Richter, Head of VAYA Pharma Research Center at Enzymotec.
"Vayarol® offers a unique composition that now provides a
clinically proven advantage for patients that present risks factors
associated with cardiovascular disease. Existing Omega 3
preparations only address a fraction of these factors while making
others worse. We look forward to leveraging these positive
results as we continue our focus on research and
development."
About VAYA Pharma
VAYA Pharma is a specialty pharmaceutical division of Enzymotec
Ltd. dedicated to the discovery, development, manufacture and
marketing of innovative proprietary clinically tested
lipid-based compositions familiar to the human body for addressing
disorders that are impacted by lipid imbalances.
VAYA Pharma's medical food portfolio addresses three therapeutic
segments: ADHD (Vayarin®), Early Memory Impairment (Vayacog®) and
Hypertriglyceridemia (Vayarol®). VAYA Pharma products are available
in the US only by prescription under the supervision of a
physician. VAYA Pharma USA is headquartered in Greenville, South
Carolina. For more information, visit www.vayapharma.com.
About Enzymotec Ltd.
Enzymotec is a leading global supplier of specialty lipid-based
products and solutions. The Company develops, manufactures and
markets innovative bio-active lipid ingredients, as well as final
products, based on sophisticated processes and technologies. For
more information, visit www.enzymotec.com.
Forward Looking Statements
This release may contain forward-looking statements, which
express the current beliefs and expectations of Company management.
Such statements involve a number of known and unknown risks and
uncertainties that could cause our future results, performance or
achievements to differ significantly from the results, performance
or achievements expressed or implied by such forward-looking
statements. Important factors that could cause or contribute to
such differences include the following risks: A high proportion of
the sales of the InFat product is sold to end users in China and to
a single company; The demand for products based on Omega-3 and in
particular, premium products, such as krill oil, has declined and
may continue to decline following a significant increase in
manufacturing capacity by manufacturers of these products,
resulting in intense competition and price pressure; Our offering
of products as "medical foods" in the United States may be
challenged by regulatory authorities; We rely on our Swedish joint
venture partner to manufacture InFat and certain matters related to
the joint venture are the subject of disagreement in arbitration
proceeding; We are subject to a degree of customer concentration
and our customers do not enter into long-term purchase commitments
with us; We depend on third parties to obtain raw materials, in
particular krill, necessary for the production of our products; We
are dependent on a single facility that houses the majority of our
operations; We may have to pay royalties with respect to sales of
our krill oil products in the United States or Australia and any
infringement of intellectual property of others could also require
us to pay royalties; Potential future acquisitions of companies or
technologies may distract our management, may disrupt our business
and may not yield the returns expected; We anticipate that the
markets in which we participate will become more competitive and we
may be unable to compete effectively; We may not be able to
successfully expand our production or processing capabilities; Our
ability to obtain krill may be affected by conservation regulation
or initiatives; Our product development cycle is lengthy and
uncertain, and our development or commercialization efforts for our
products may be unsuccessful; and other factors discussed under the
heading "Risk Factors" in the Company's Form 20-F filed with the
Securities and Exchange Commission on March 2, 2015.
Forward-looking statements in this release are made pursuant to the
safe harbor provisions contained in the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
made only as of the date hereof, and the Company undertakes no
obligation to update or revise the forward-looking statements,
whether as a result of new information, future events or
otherwise.
CONTACT: KCSA Strategic Communications
Jeffrey Goldberger/Tram Bui
212-896-1249/212-896-1290
ENZY@kcsa.com
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