SOURCE: Applied DNA Sciences

Applied DNA Sciences

March 17, 2015 05:30 ET

Applied DNA Sciences Announces SigNature® DNA Compliance With FDA Guidelines

Regulatory Firm of Covington & Burling Completes Their Review of the Regulatory Status of DNA Taggants

STONY BROOK, NY--(Marketwired - March 17, 2015) - Applied DNA Sciences, Inc. (NASDAQ: APDN) (Twitter: @APDN), a provider of DNA-based anti-counterfeiting technology, supply chain and product authentication solutions, today announced that Covington & Burling, considered the best law firm in the US for FDA law (source: U.S. News and World Report), considers SigNature DNA to be immediately suitable for inclusion in prescription drugs in order to authenticate their originality and thereby exclude counterfeit drugs from the supply chain.

FDA has been deeply concerned about the rapid growth and increased sophistication of illegal counterfeiting of FDA-regulated products. In October 2011, FDA published a Final Guidance document on the use of so called "Physico-Chemical Identifiers" (PCIDs). SigNature DNA is used in drugs at levels of approximately 1 part per trillion (1 in 1012); this level of SigNature DNA is less than 1/100,000th the level of DNA considered permissible as a contaminant in oral doses. Any PCID that satisfies the general principals established in the FDA Guidance is highly likely to be acceptable for any FDA-regulated product, except for those subject to an FDA-approved New Drug Application.

The extremely low levels of SigNature DNA required to authenticate a single dose are so small that they cannot adversely affect drug product integrity.

The FDA Guidance stipulates that a PCID should be pharmacologically inactive and present no risk of adverse reaction. The PCID cannot affect the efficacy of the drug. In addition, 11 categories of information about the PCID must be satisfactorily addressed. SigNature DNA fulfilled all of these requirements, and is equally applicable to food and cosmetics.

Dr. James Hayward, CEO and President of APDN, commented: "Counterfeit drugs penetrate every level of the global community, causing mortality, morbidity and enormous economic loss. There is an enormous market we can service, with counterfeit drug sales surpassing $200 billion per year."

Peter Barton Hutt, Senior Counsel for Covington, and a prior Chief Counsel for FDA, stated: "Counterfeit drugs are an extraordinary scourge on the healthcare marketplace. APDN's SigNature DNA offers a safe, effective and FDA-compliant way to secure the global pharmaceutic supply chain."

About Applied DNA Sciences
We make life real and safe by providing botanical-DNA based security and authentication solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. SigNature® DNA describes the platform ingredient that is at the heart of all of our security and authentication solutions. SigNature® DNA is at the core of a family of uncopyable products such as DNAnet®, our anti-theft product, SigNature® T, targeted toward textiles, and digitalDNA®, providing powerful track and trace. All provide a forensic chain of evidence and can be used to prosecute perpetrators.

Applied DNA Sciences common stock is listed on NASDAQ under the symbol APDN, and its warrants are listed under the symbol APDNW. 

Forward-Looking Statement
The statements made by APDN in this press release may be "forward-looking" in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe APDN's future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of APDN. Actual results could differ materially from those projected due to our short operating history, limited financial resources, limited market acceptance, market competition and various other factors detailed from time to time in APDN's SEC reports and filings, including our Annual Report on Form 10-K filed on December 15, 2014, and our subsequent quarterly report on Form 10-Q which are available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

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