RADNOR, Pa., July 13, 2012 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX), a biotechnology company focused on developing innovative therapeutic drugs to treat patients with serious acute-care conditions, today outlined the potential benefits that the Generating Antibiotics Incentives Now (GAIN) Act will have for PolyMedix.
Signed into law this week, the GAIN Act provides incentives for the development of qualified infectious disease products, including antibiotic drugs for treating drug resistant pathogens. PolyMedix may potentially benefit from this legislation in multiple ways, including:
Fast Track Status. Sponsors could request that any qualified infectious disease product be designated a fast track product, providing for expedited development and review of the application for approval. This generally involves early and frequent communications with the U.S. Food and Drug Administration (FDA), in addition to the typical review and communication opportunities, helping speed the path from Phase 1 clinical trials to the filing of a New Drug Application (NDA).
Priority Review. New Drug Applications for qualified infectious disease products are entitled to priority review by the FDA, reducing the standard 12 month review period to 6 months.
Exclusivity. Qualified infectious disease products will be entitled to an additional 5 years of market exclusivity in addition to the standard 5 years of exclusivity for a new chemical entity under the Hatch-Waxman Act.
The GAIN Act requires the FDA to provide sponsors of qualified infectious disease products with written recommendations for the nonclinical and clinical investigations believed to be necessary for approval. The Act also requires the FDA to review and revise, as appropriate, its guidelines for the conduct of clinical trials with respect to antibiotic drugs within one year of enactment.
Nicholas Landekic, President and CEO of PolyMedix commented, "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."
The GAIN Act defines qualifying pathogens to include Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA), a current target of PolyMedix's defensin mimetic compound, brilacidin (PMX-30063). Qualifying pathogens also include vancomycin-resistant Staphylococcus and Enterococcus, multi-drug resistant Gram-negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species, and multi-drug resistant tuberculosis. PolyMedix's compounds have demonstrated activity against many of these pathogens in pre-clinical studies.
About PolyMedix, Inc.
PolyMedix is a clinical stage biotechnology company developing a novel class of antimicrobial agents – cidins, small-molecule mimetics of host-defense proteins - for the treatment of serious infections. PolyMedix's lead infectious disease drug candidate is brilacidin (formerly PMX-30063), the first of this new class of antibiotics which 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. Brilacidin has completed a Phase 2 clinical trial in patients with acute bacterial skin and skin structure infections (ABSSSI) caused by Staph aureus bacteria, including methicillin-resistant Staph aureus (MRSA). In the study, all evaluated doses of brilacidin showed efficacy comparable to the active control and were safely administered.
PolyMedix's product portfolio also includes its PolyCides®, antimicrobial additives to materials, such as cosmetics, plastics and textiles, to create self-sterilizing products and surfaces, and delparantag (formerly PMX-60056) and other preclinical anticoagulant reversing agents. PolyMedix's compounds have been internally discovered using a proprietary drug design technology.
For more information, please visit our website at www.polymedix.com.
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This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause PolyMedix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. PolyMedix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are PolyMedix's need for, and the availability of, substantial capital in the future to fund its operations and research and development, and the fact that PolyMedix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in PolyMedix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. PolyMedix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.