Synthetic Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing novel anti-infective biologic and drug programs targeting specific pathogens that cause serious infections and diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to the Company's proprietary SYN-005 monoclonal antibody (mAb) combination for the treatment of Pertussis, more commonly known as whooping cough. In the U.S., Orphan Drug Designation provides a variety of incentives, including seven years of market exclusivity, should SYN-005 receive FDA approval for the treatment of Pertussis.
"Achieving this milestone is an important step in building the foundation for our Pertussis clinical program. The next anticipated milestone for SYN-005 is to initiate cGMP manufacturing in the second half of this year, followed by the filing of an IND in mid-2015 to support the initiation of a Phase I clinical trial," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "We expect this to become an important new treatment option for patients suffering from Pertussis."
Synthetic Biologics is developing SYN-005 through its Exclusive Channel Collaboration with Intrexon Corporation (NYSE: XON) and academic researchers at The University of Texas at Austin to target and neutralize the pertussis toxin in order to reduce morbidity and mortality in infected infants. Pertussis is a highly contagious disease caused by the bacteria Bordetella pertussis (B. pertussis) with symptoms that may include chronic coughing and subsequent breathing difficulties. According to the World Health Organization, there are approximately 50 million worldwide cases of whooping cough each year, leading to an estimated 300,000 deaths, primarily among young, unvaccinated infants.
The Orphan Drug designation is granted to development-stage novel therapeutics that offer potential value in the treatment of rare diseases and medical conditions that affect fewer than 200,000 patients in the US. Orphan Drug designation qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received Orphan Drug designation is not subject to the Prescription Drug User Fee Act (PDUFA) fees unless the application includes an indication for other than the rare disease or condition for which the therapeutic was designated.
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