Healthcare Industry News: ACTICOAT
News Release - July 19, 2007
NUCRYST Pharmaceuticals receives FDA clearance of antimicrobial barrier topical creamWAKEFIELD, MA, July 19 (HSMN NewsFeed) - NUCRYST Pharmaceuticals Corp. today announced that the US Food & Drug Administration (FDA) has granted 510(k) clearance for a prescription topical cream containing NPI 32101, the company's patent-protected nanocrystalline silver, as a broad-spectrum antimicrobial barrier.
"NPI 32101 cream represents a new presentation of our patented nanocrystalline silver technology," said Scott H. Gillis, President & CEO, NUCRYST Pharmaceuticals Corp. "Gaining FDA clearance is a first step toward marketing our proprietary technology in this new formulation. We are actively exploring commercialization options and as part of this process, market plans and timing for this product will be determined."
In vitro studies have demonstrated that NPI 32101 cream serves as a broad-spectrum antimicrobial barrier to organisms including Pseudomonas aeruginosa and Staphylococcus aureus, including strains resistant to Methicillin (MRSA). Clinical studies involving more than 600 adults and children have also demonstrated that it has a strong safety profile.
NUCRYST Pharmaceuticals (NASDAQ: NCST ; TSX: NCS ) develops, manufactures and commercializes medical products that fight infection and inflammation using its patented atomically disordered nanocrystalline silver technology. Smith & Nephew plc sell a range of advanced wound care products under their ACTICOAT(TM) trade mark. ACTICOAT(TM) products incorporate NUCRYST's SILCRYST(TM) coatings and are sold in over 30 countries. NUCRYST is also developing pharmaceutical products to address medical conditions that are characterized by both infection and inflammation. The Company has developed its proprietary nanocrystalline silver in a powder form for use as an active pharmaceutical ingredient, referred to as NPI 32101.
SILCRYST(TM) is a trademark of NUCRYST Pharmaceuticals Corp.
ACTICOAT(TM) is a trademark of Smith & Nephew plc
Some of the statements above may constitute forward-looking statements within the meaning of securities legislation in the United States and Canada (collectively "forward looking statements"). The words "exploring", "will" and "plans" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this news release include, but are not limited to, statements about the prospects and plans for our barrier cream. With respect to the forward-looking statements contained in this news release, readers are cautioned that numerous risks, uncertainties and other factors could cause our actual results to differ materially from those indicated in these statements including, but not limited to: difficulties or delays in the initiation, timing, progress and results of commercialization efforts; we may not be able to maintain regulatory approval for our barrier cream; we may not be able to attract, establish or maintain sales and marketing collaborations relating to the development and commercialization of our barrier cream; our ability to raise additional financing required to fund further development and commercialization of our barrier cream on commercially acceptable terms or at all; competition from other silver-based pharmaceutical or medical device companies; our ability to protect our intellectual property rights and to not infringe on the intellectual property rights of others; our ability to comply with governmental regulations and standards; changes in general economic conditions; other risks and uncertainties unidentified at this time; management's response to these factors; and other factors described under "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2006, filed with the U.S. Securities and Exchange Commission at www.sec.gov and with securities authorities in Canada at www.sedar.com. All forward-looking statements are expressly qualified in their entirety by this cautionary statement and NUCRYST disclaims any intention or obligation to revise or update any forward-looking statements whether as a result of new information, future developments or otherwise after the date hereof.
Source: NUCRYST Pharmaceuticals
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