Applied DNA Accepted Into U.S. FDA’s Emerging Technology Program, Creating Pathway for Molecular Tagging of Pharmaceuticals...
01 May 2020 - 12:59AM
Business Wire
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Security -
Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the
“Company”) today announced that the Emerging Technology Team (ETT)
of the U.S. Food and Drug Administration (FDA) has accepted the
Company into its Emerging Technology Program (ETP) for the
molecular tagging of Solid Oral Dosage Forms (SODF). The ETP serves
to help promote the adoption of innovative approaches to
pharmaceutical product design and manufacturing and offers
technology companies and their pharmaceutical customers the
opportunity to discuss, identify, and resolve potential technical
and regulatory pathways early in the development and implementation
of novel technology.
ETP also affords FDA the opportunity to become familiar with new
technologies prior to regulatory submissions. From the ETT’s home
within the Center for Drug Evaluation and Research (CDER), it can
offer reach into various FDA groups to support programs which may
straddle responsible organizations such as with the Center for
Biologics Evaluation and Research (CBER). Applied DNA follows into
the ETP other industry-leading technology companies who have
navigated the simultaneous challenges of compliance and new process
innovation such as the first 3D-printing of drug tablets,
transforming from batch to continuous processes for manufacturing,
and the use of IoT in controlling manufacturing quality.
Applicants to the program are evaluated by FDA on whether the
proposed technology has the potential to improve product safety,
identity, strength, quality, or purity, or includes one or more
elements of quality management (e.g., product design, manufacturing
process, testing or process controls) for which the agency has
limited review or inspection experience. The ETT promotes early
engagement, face-to-face meetings, site visits and pre-approval
inspections. Members of the ETT engaged with Applied DNA are likely
to participate with the Company throughout the entire development
of a customer’s molecular tagging program.
“With the overwhelming majority of domestic drug production
reliant on the importation of active pharmaceutical ingredients
from overseas sources, there is an underappreciated and pressing
need for product security across global pharmaceutical supply
chains,” stated Dr. James Hayward, president and CEO of Applied
DNA. “We are already aligned with partners that offer us a path to
drive industry adoption of our authentication technologies and
mitigate participation of counterfeit and adulterated drugs in the
legitimate pharmaceutical supply chain, such as, Colorcon, a leader
in the development, supply and support of formulated products for
the pharmaceutical industry; Videojet, a world-leader in the inkjet
printing market; and Schreiner Group, specializing in innovative,
functional labels and integrated security solutions across many
industries, including the pharmaceutical industry.”
Judy Murrah, Chief Information Officer of Applied DNA., said,
“Applied DNA’s authentication technology is a robust, multi-layered
platform that complements FDA’s Drug Quality and Supply Chain
Security Act serialization initiative. The introduction of an
immutable identity for traceability and authenticity to both the
dose and the packaging supports product investigations even when
the two become separated. It is potentially a game-changer for the
pharmaceutical industry. Such forensic data has been used as
evidence in European courts to support the conviction of 138
criminals, setting the table in the pharmaceutical industry as
support for investigations of product liability, counterfeiting and
diversion.”
About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable
supply chain security, anti-counterfeiting and anti-theft
technology, product genotyping, diagnostics and pre-clinical
nucleic acid-based therapeutic drug candidates.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc.
Visit adnas.com for more information. Follow us on Twitter and
LinkedIn. Join our mailing list.
The Company’s common stock is listed on NASDAQ under ticker
symbol ‘APDN’, and its publicly traded warrants are listed on OTC
under ticker symbol ‘APPDW’.
Forward-Looking Statements
The statements made by Applied DNA in this press release may be
“forward-looking” in nature within the meaning of Section 27A of
the Securities Act of 1933, Section 21E of the Securities Exchange
Act of 1934 and the Private Securities Litigation Reform Act of
1995. Forward-looking statements describe Applied DNA’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 Applied DNA. Actual results
could differ materially from those projected due to the possibility
of a failure to make timely payment on its outstanding secured
convertible notes and resulting enforcement by noteholders of
remedies on collateral which includes substantially all of Applied
DNA’s assets, its history of net losses, limited financial
resources, limited market acceptance, the uncertainties inherent in
research and development, future clinical data and analysis,
including whether any of Applied DNA’s or its partners diagnostic
or therapeutic candidates will advance further in the preclinical
research or clinical trial process, including receiving clearance
from the U.S. Food and Drug Administration or equivalent foreign
regulatory agencies to conduct clinical trials and whether and
when, if at all, they will receive final approval from the U.S. FDA
or equivalent foreign regulatory agencies, the unknown outcome of
any applications to U.S. FDA or equivalent foreign regulatory
agencies and various other factors detailed from time to time in
Applied DNA’s SEC reports and filings, including our Annual Report
on Form 10-K filed on December 12, 2019 and our subsequent
quarterly report on Form 10-Q filed on February 6, 2020, and other
reports we file with the SEC, which are available at www.sec.gov.
Applied DNA undertakes no obligation to update publicly any
forward-looking statements to reflect new information, events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events, unless otherwise required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20200430005634/en/
investor contact: Sanjay M. Hurry, LHA Investor
Relations, 212-838-3777, shurry@lhai.com program contact:
Judy Murrah, Chief Information Officer, Applied DNA, 631-240-8819,
judy.murrah@adnas.com web: www.adnas.com,
https://adnas.com/linearx twitter: @APDN
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