Navigation Links
Synthetic Biologics Reports that Flupirtine Sublicensee, Meda AB, to Initiate Phase II Fibromyalgia Clinical Trial in U.S.
Date:2/22/2013

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.

To download Synthetic Biologics' investor relations mobile device app, which allows users access to the Company's SEC documents, press releases and events, please click on the following links to download the IRapp on your iPhone and iPad or your Android mobile device.

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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Inovios Synthetic Flu Vaccine Doubles Rate of Elderly Subjects Displaying Protective Immune Responses
2. Synthetic Biologics Closes Deal for Acquisition of C. difficile Infectious Disease Program
3. Inovio Expands Synthetic Vaccine Intellectual Property License With University of Pennsylvania
4. The Use of New Replikins Synthetic Vaccines to Prevent Pandemics to be Presented at Influenza Congress Nov. 12 in Washington DC
5. Synthetic Biologics Initiates Development of Monoclonal Antibodies for Treatment of Acinetobacter Infections
6. Synthetic Biologics Reports Second Quarter 2012 Financial Results
7. Synthetic Biologics Appoints Carol Reed, M.D., as Senior Vice President of Clinical & Regulatory Affairs
8. Inovio Pharmaceuticals Granted U.S. Patent Protection for Synthetic Vaccine for Cervical Dysplasia and Cancer
9. Employers Becoming Savvier About Biologics and Specialty Drugs
10. Pinnacle Biologics beantragt Zulassung neuer Indikationen in Deutschland und Frankreich
11. Pinnacle Biologics dépose une nouvelle indication pharmaceutique en Allemagne et en France
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... Newborns are highly vulnerable to infections ... their young immune systems typically mount weak antibody ... achieving strong vaccine responses in newborn animals, including ... trials — by adding compounds known as adjuvants ... papers, they also describe improved adjuvant formulations that ...
(Date:3/23/2017)... LONDON , March 23, 2017 ... efficacy from the TACTI-mel trial of IMP321 in combination ... in the first (1mg/kg) cohort experiencing a complete response. ... final cohort is expected to be fully recruited by ... of the AIPAC breast cancer study are expected mid-year ...
(Date:3/23/2017)... March 23, 2017 ... Enterprises Limited, gibt die Ernennung von Stuart ... bietet seinen globalen Pharmazeutikkunden eine einmalige integrierte ... wichtige Rolle für das erfolgreiche Wachstum und ... Leiter wird Herr Needleman dafür verantwortlich sein, ...
Breaking Medicine Technology:
(Date:3/23/2017)... Houston, Texas (PRWEB) , ... March 23, 2017 , ... ... their 3rd location in the greater Houston Area. The new location is located at ... St. Luke’s Hospital in Springwoods Village. This newest location will provide patients living in ...
(Date:3/23/2017)... ... March 23, 2017 , ... The IoT (Internet of Things) is revolutionizing ... a huge impact on businesses and individual consumers alike. Laboratories can maximize their ... a value anywhere from $4 trillion to $11 trillion dollars by the year 2025. ...
(Date:3/23/2017)... ... March 23, 2017 , ... March is National Kidney Month – the ... it comes to maintaining good health. Every day, two kidneys filter about 120 to ... drop of your blood, eliminating waste, regulating fluid levels and blood pressure, supporting bone ...
(Date:3/23/2017)... ... 2017 , ... The Wound Certification Prep Course (WCPC) ... LLC, today announced that RestorixHealth® has officially endorsed WCPC as its ... in becoming Certified Wound Specialist Physicians (CWSP®). , This collaborative effort with ...
(Date:3/23/2017)... ... March 23, 2017 , ... After raising more than ... , the most-funded travel pillow in crowdfunding history, has established a U.S. ... wildly popular travel innovation to Americans. , “We’re excited to be operating on U.S. ...
Breaking Medicine News(10 mins):