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Synthetic Biologics, Inc. (SYN) Flupirtine Sublicensee Receives FDA Green Light For Phase II Fibromyalgia Clinical Trial In U.S.

|Includes: Synthetic Biologics, Inc. (SYN)

Friday, synthetic biologics and innovative medicine developer Synthetic Biologics announced that Meda AB, its flupirtine sublicensee, has been given a green light by the U.S. Food and Drug Administration to conduct a Phase II proof of concept study for the treatment of fibromyalgia, as reported in Meda's year-end report for 2012. The randomized, double-blind, placebo and active-controlled study of fibromyalgia patients will be conducted at 25 U.S. clinics, as reported by Meda.

In May of 2010, Synthetic Biologics entered into an agreement with Meda, a company based in Sweden, granting exclusive sublicense to all of its patents and pending patents that cover the use of flupirtine for fibromyalgia in the United States, Canada, and Japan. Meda assumed all future development costs for commercializing flupirtine for fibromyalgia. Synthetic Biologics was given an upfront payment and is entitled to future milestone payments and royalties.

A chronic and debilitating condition, fibromyalgia is characterized by pain and stiffness throughout the body, as well as severe fatigue, insomnia, and mood symptoms. Approximately 3 to 6 percent of the global population is affected by fibromyalgia, including around 10 million patients in the United States. Currently, three products have been approved for this indication in the U.S. - Lyrica, Cymbalta, and Savella. Flupirtine is different from these products in that it uses a unique mode of action.

A first-in-class, novel type of central nervous system agent known as a selective neuronal potassium channel opener, flupirtine has NMDA receptor agonist properties. It is currently approved and marketed by Meda for pain treatment in several countries outside of the U.S.

"We are pleased to share Meda's update on the status of its clinical development program of flupirtine for fibromyalgia," said Synthetic Biologics CEO Jeffrey Riley. "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."

A biotechnology company, Synthetic Biologics is focused on developing product candidates for serious infections and diseases. The company is developing a biologic for the prevention of C. difficile infection, as well as a series of monoclonal antibodies to treat serious infectious diseases, such as pertussis and Acinetobacter. Synthetic Biologics is developing a synthetic DNA-based therapy for treating pulmonary arterial hypertension, as well as a drug candidate for treating relapsing-remitting multiple sclerosis and cognitive dysfunction in MS. The company is additionally designing a clinical development pathway for treating amyotrophic lateral sclerosis, in addition to its partnership with Meda AB for the development of a fibromyalgia treatment.

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