MIGDAL HA'EMEQ, Israel, July 7, 2015 (GLOBE NEWSWIRE) -- Enzymotec Ltd. (Nasdaq:ENZY) ("Enyzmotec" or the "Company"), a developer, manufacturer and marketer of innovative bio-active lipid-based nutritional ingredients and medical foods, announced today that Dr. Sylvain Rheims, Head of the Department of Functional Neurology and Epileptology at Hospices Civils de Lyon, France, commenced an investigator initiated clinical trial of Vayarin® in managing Attention Deficit Hyperactivity Disorder ("ADHD") in children with epilepsy.
Vayarin®is a proprietary prescription medical food for the clinical dietary management of lipid imbalances associated with ADHD. Vayarin®'s unique lipid composition contains phosphatidylserine enriched with Eicosapentaenoic Acid ("EPA"), an essential molecule for the management of key biochemical modifications underlying various brain processes that control attention span, impulsivity and hyperactivity.
The efficacy and safety of Vayarin® have been evaluated in children with ADHD. Past clinical trials demonstrated the product's ability to successfully manage symptoms associated with ADHD and proved safe and well-tolerated. Competing treatments for ADHD have the potential to impair neurological circuit function. Therefore, this new study serves as a crucial step in addressing the need for safer alternatives for the management of ADHD in children with epilepsy.
Dr. Sylvain Rheims, the Principal Investigator, commented, "Epidemiological studies suggest that the prevalence of ADHD in children suffering from epilepsy is significantly higher when compared to the general population. Considering the potential for popular ADHD treatments to have a negative impact on this population, we hope to safely address the symptoms of ADHD. Data supporting Vayarin®'s suitability for the treatment of ADHD in children with epilepsy will support a unique and strongly needed way to manage ADHD in this population."
The multi-center study is designed as a 12-week, double blind, placebo-controlled trial, which will be followed by a 12-week open label extension phase. The randomized study will consist of 272 children between the ages of 6-16 years old recruited from a maximum of 10 sites in France. The main goal of the study is to assess the efficacy of Vayarin®versus placebo in managing ADHD symptoms in children with epilepsy.
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 U.S. 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 and www.vayarin.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 based nutritional ingredients and medical foods, driven by a deep core of cutting-edge, proprietary technologies intended to improve people's health. For more information, visit www.enzymotec.com.
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