ROCKVILLE, Md., Feb. 22, 2013 /PRNewswire/ — Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics and innovative medicines for serious infections and diseases, announced today that its flupirtine sublicensee, Meda AB (Meda), has received a green light from the Food and Drug Administration (FDA) to conduct a Phase II proof of concept study for the treatment of fibromyalgia as reported in Meda’s 2012 year-end report. Meda has announced that the randomized, double-blind, placebo and active-controlled study of patients with fibromyalgia will be conducted at 25 clinics in the U.S.
In May 2010, the Company entered into an agreement with Sweden-based Meda granting exclusive sublicense to all of its patents and pending patents covering the use of flupirtine for fibromyalgia in the U.S., Canada and Japan. Meda assumed all future development costs for the commercialization of flupirtine for fibromyalgia. Synthetic Biologics received an upfront payment and is entitled to future milestone payments, plus royalties.
“We are pleased to share Meda’s update on the status of its clinical development program of flupirtine for fibromyalgia,” stated Jeffrey Riley, Chief Executive Officer at Synthetic Biologics. “We believe Meda’s experience with flupirtine outside of the U.S. will help bring this potential new class of treatment to the millions of people that suffer from fibromyalgia in the U.S.”
About Fibromyalgia and Flupirtine
Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. Fibromyalgia affects an estimated 3-6% of the population worldwide, including an estimated 10 million patients in the U.S. There are presently three products approved for this indication in the U.S. – Lyrica®, Cymbalta® and Savella®. Flupirtine is differentiated from these products in that it employs a unique mode of action.
Flupirtine is a first-in-class, novel type of central nervous system agent known as a selective neuronal potassium channel opener that also has NMDA receptor antagonist properties. Flupirtine is currently approved and marketed by Meda for the treatment of pain in various countries outside of the U.S.
About Synthetic Biologics, Inc.
Synthetic Biologics is a biotechnology company focused on the development of product candidates for serious infections and diseases. Synthetic Biologics is developing a biologic for the prevention of C. difficile infection, and a series of monoclonal antibodies for the treatment of serious infectious diseases, including pertussis and Acinetobacter. The Company is also developing a synthetic DNA-based therapy for the treatment of pulmonary arterial hypertension. In addition, the Company is developing a drug candidate for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS, is designing a clinical development pathway for the treatment of amyotrophic lateral sclerosis and has partnered the development of a fibromyalgia treatment to Meda AB. For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.
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This release includes forward-looking statements on Synthetic Biologics’ current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding Meda’s prior experience with flupirtine and its impact on U.S. regulatory approval. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics’ forward-looking statements include, among others, a failure to achieve regulatory approval and other factors described in Synthetic Biologics’ report on Form 10-K/A for the year ended December 31, 2011 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
SOURCE Synthetic Biologics, Inc.
Released February 22, 2013