Enzymotec Ltd. Announces Initiation of a Clinical Study on Autism Spectrum Disorder
August 12, 2014
MIGDAL HA'EMEQ, Israel, Aug. 12, 2014 (GLOBE NEWSWIRE) - Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, announced the initiation of a clinical study on Autism Spectrum Disorder (ASD) symptoms.
"We believe the initiation of this study is an important step toward our ability to develop a promising new approach for helping children experiencing ASD symptoms," said Dr. Ariel Katz, President and Chief Executive Officer of Enzymotec Ltd.
This study is an exploratory, randomized, placebo-controlled trial conducted in the U.S. Children between the ages of 6 and 13 will be randomized to receive either treatment or a placebo over 14 weeks, following a two week initial screening period. The study principle investigator is Dr. Eric Hollander, director of the Spectrum Neuroscience and Treatment Institute specializing in Psychiatry, Neuropsychopharmacology and Clinical Neuroscience.
"This study will give us important insights into the efficacy and safety of our product in managing ASD symptoms," said Dr. Yael Richter, Vice President VAYA Pharma Research & Development at Enzymotec Ltd. "According to the Center of Disease Control and Prevention, the overall prevalence of ASD in 2010 among the Autism and Developmental Disabilities Monitoring Network sites was 14.7 per 1,000, or one in 68 children up to 8 years old. Today, treatment and education approaches may reduce some of the challenges associated with the condition, yet there remains a significant unmet need for treatments that are both effective and safe."
About Enzymotec Ltd.
Enzymotec Ltd. 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 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; 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. 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 forwardlooking statements, whether as a result of new information, future events or otherwise.