Radnor, PA-based PolyMedix is one company that hopes to benefit from the GAIN Act, which would give companies accelerated FDA approval, longer exclusivity and increased FDA guidance to reduce clinical study timelines.
(PRWEB) July 13, 2012
A new law signed into effect by President Obama this week is expected to assist researchers in developing new antibiotics for the most difficult to treat bacteria infections. Called the GAIN Act (Generating Antibiotics Incentives Now), the law provides incentives for companies to develop completely new antibiotics that can treat the most challenging bacterial infections that have become resistant to current treatments.
The law was passed to address an anticipated shortfall of new antibiotics. Few have been developed over the last decade as drug companies concluded that there were more profitable areas in which to focus their research. But the emergence of resistant organisms has alarmed infectious disease experts from around the world. The GAIN act provides financial and other incentives to bring drug makers back into the market, developing newer antibiotics to address resistant pathogens.
Radnor, PA-based PolyMedix is one company that hopes to benefit from the GAIN Act, which would give companies accelerated FDA approval, longer exclusivity and increased FDA guidance to reduce clinical study timelines. “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,” commented Nicholas Landekic, President and CEO of PolyMedix. “This is landmark legislation that should help insure we have the drugs needed to combat todays, and tomorrows, most dangerous pathogens.”
The GAIN Act would provide incentives for companies to develop qualified infectious disease products that treat bacterial infections that have become resistant to current treatments. PolyMedix, for instance, is developing brilacidin in mid-stage studies to combat methicillin-resistant Staphylococcus aureus (MRSA). It would be the first of a new class of antibiotics called defensin-mimetics that imitates the mechanism of human immunity, exploiting a method of killing bacteria that has never led to resistance.
The new law could also encourage faster development of treatments for other bacterial infections including vancomycin-resistant Staphylococcus and enterococcus, multi-drug resistant gram-negative bacteria Acinetobacter, Klebsiella, Pseudomonas, and E. coli species, multi-drug resistant tuberculosis, and Clostridium difficile.