MIGDAL HA'EMEQ, Israel, April 30, 2015 (GLOBE NEWSWIRE) -- 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