Friday, PolyMedix issued a press release that discussed potential benefits the company stands to gain from the passing of the Generating Antibiotics Incentives Now (GAIN) Act into law. The GAIN Act, signed into law last week, will provide incentives for the development of infectious disease products that qualify under the Act, including antibiotics intended to treat drug-resistant pathogens.
PolyMedix is a clinical-stage biotechnology company that is focused on developing a new class of antimicrobial agents, known as cidins, for use in the treatment of serious infections. The first of this new class, brilacidin, imitates the mechanism of natural human immunity, and exploits a method of bacterial cell killing which has not shown bacterial resistance in multiple preclinical studies. PolyMedix has previously introduced PolyCides – antimicrobial additives to materials, such as cosmetics, plastics, and textiles, which create self-sterilizing products and surfaces.
The ways PolyMedix anticipates the GAIN act will benefit the company are: Fast Track Status, which will expedite development and review of the application for approval; Priority Review, which reduces the standard 12 month FDA review period to 6 months; and Exclusivity, which will see qualified infectious disease products being entitled to an additional 5 years of market exclusivity in addition to the standard 5 years of exclusivity they were allowed previously.
Nicholas Landekic, president and CEO of PolyMedix, said, “The GAIN Act provides companies like PolyMedix with an opportunity for priority access to the FDA for dialogue, clear clinical objectives and predictable timetables that should make antibiotic drug development more efficient and valuable for investors. This is landmark legislation that should help insure we have the drugs needed to combat today’s, and tomorrow’s, most dangerous pathogens.”
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