Enzymotec Ltd. Initiates Clinical Study of Vayarin(R) in Adult ADHD
November 11, 2014
MIGDAL HA'EMEQ, Israel, Nov. 11, 2014 (GLOBE NEWSWIRE) - Enzymotec Ltd., (Nasdaq: ENZY), a developer, manufacturer, and marketer of innovative bio-active lipid based nutritional ingredients and medical foods, today announced the initiation of a clinical study to evaluate the efficacy of Vayarin® in adults with Attention Deficit Hyperactivity Disorder, or ADHD.
"The initiation of this study is an important milestone for Enzymotec as we focus on expanding the target population that can benefit from Vayarin beyond the current indication for children. The high risk of abuse is a critical factor when trying to manage ADHD in the adult population. The fact that Vayarin is considered safe, with no addictive side effects, represents a tremendous advantage in the management of ADHD," stated Robert Crim, CEO of VAYA Pharma, a division of Enzymotec Ltd.
The randomized, double-blind, placebo-controlled study will enroll 171 patients between the ages of eighteen and fifty-five. This will be a multi-center study in the United States, including the NYU School of Medicine (Dr. Lenard Adler, PI). The study was designed to assess the efficacy of Vayarin in adults with ADHD, measured primarily by the ADHD Investigator Symptom Rating Scale (AISRS).
"Vayarin has been clinically shown to be safe and effective for the management of ADHD in children. We hope this study will validate the benefits of Vayarin in adults with ADHD," commented Dr. Yael Richter, Head of VAYA Pharma Research Center at Enzymotec. "Vayarin is a unique lipid composition specifically designed to manage certain lipid imbalances associated with this lifelong neurodevelopmental disorder that tends to persist into adulthood. Approximately 60 percent of children with ADHD carry the disorder into adulthood. This translates into approximately 4 percent of the adult population, or 8 million adults in the United States, which creates a large opportunity for Enzymotec."
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.
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 the following risks: we depend on third parties to obtain raw materials, in particular krill, necessary for the production of our products; a high proportion of the sales of our INFAT® product is sold to end users by a single company in China; we are subject to a degree of customer concentration and our customers do not enter into long-term purchase commitments with us; we may be required to pay royalties on sales of our krill products in North America and Australia; we have in the past, and may in the future, become subject to litigation regarding intellectual property rights or other matters; unexpected litigation results or expense (including in connection with the securities class action pending against us in the United States District Court for the District of New Jersey); 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 have recently entered into an arbitration proceeding with our partner with respect to certain matters related to the joint agreement; we are dependent on a single facility that houses the majority of our operations; we may be impacted by delays in manufacturing as we expand our capacity; we may not be able to expand our production or processing capabilities or satisfy growing demand; our gross profits may be adversely affected if we are only able to obtain lower quality krill meal; 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; we and our customers are subject to significant and increasing government regulations regarding the sale and marketing of our products and our customers' products incorporating our products; we may not be able to protect our proprietary technology or prevent its unauthorized use by third parties; and other factors discussed under the heading "Risk Factors" in the Company's Form 20-F filed with the Securities and Exchange Commission on February 13, 2014. Forwardlooking 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.
KCSA Strategic Communications
Jeffrey Goldberger / Tram Bui
212.896.1249 / 212.896.1290