Business Wire

Applied DNA Signs Definitive Agreements with Colorcon for Molecular Tagging in the Pharmaceutical and Nutraceutical Markets

Jaa

Applied DNA Sciences, Inc., (NASDAQ: APDN) (“Applied DNA” or the “Company,”) has signed a License and Cooperation Agreement and a related Supply Agreement (collectively known as the “Agreements”), effective March 31, 2018, with Colorcon, Inc. (“Colorcon”) for the use of Applied DNA’s SigNature® molecular tags in Colorcon’s product offerings and access to the Company’s associated authentication technologies. These Agreements follow the memorandum of understanding (MOU) announced on December 18, 2017.

Under the terms of the Agreements, Applied DNA grants Colorcon exclusive worldwide right to use the Company’s molecular tags and associated authentication technologies in film coatings for solid oral dosage form (“SOD”) applications, for which Colorcon is the largest global supplier, and non-exclusive rights to use the Company’s technologies in inks and colorants for SOD applications. Pursuant to the Agreements, Applied DNA will supply taggant and authentication materials to Colorcon in exchange for long-term royalties on the sale of Colorcon products incorporating the Company’s molecular tags and on the sale of authentication services related thereto. Further, the first of two milestone payments is payable to Applied DNA with the signing of the Agreements. The Company will receive the second milestone payment upon initial approval by a regulatory authority for application in a SOD pharmaceutical or nutraceutical product application. The Agreements generally expire on the later of October 1, 2032 or the last expiration date of any patent licensed pursuant to the Agreements.

“With the signing of these definitive agreements and Colorcon’s industry-leading role, we demonstrate our continuing ability to monetize our DNA molecular taggant platform and associated services to drive revenue growth. The seamless solution integrating our molecular tag with Colorcon's film coatings puts us on a path to adoption by Colorcon’s current and prospective pharmaceutical customers,” stated Dr. James Hayward, President and CEO of Applied DNA. Dr. Hayward added that: “Molecular tags will provide traceability for audits and law enforcement and, perhaps most importantly, forensic confirmation of the authenticity of the drug product to the patient and all those in the supply chain, including the pharmacist, the drug distributors and manufacturers. We are gratified to be working with a world leader whose sales channel greatly amplifies our combined access to the market.”

“Our teams are already actively engaged in discussions with potential customers,” stated Kelly Boyer, General Manager Film Coatings Business Unit for Colorcon, Inc.

Ms. Boyer continued, “Colorcon has an established reputation for innovation and service. Applied DNA’s SigNature molecular tags and authentication technologies provide value-addition at a time when regulators are demanding that the industry implement serialization in order to track packaging. The collaboration goes a significant step further by enabling traceability at the level of single unit, solid oral doses, and it is complementary to the provisions of the Drug Supply Chain Security Act.”

Colorcon has team members with extensive experience in global regulatory compliance, while Applied DNA has the benefit of several of its management team with experience in the pharmaceutical industry, and the Company has already scaled to supply large, global commercial ecosystems. Applied DNA’s Molecular Tags have been included in over 200 million pounds of cotton, over 15 million pounds of synthetic fibers, and over 800,000 microcircuits for the Department of Defense. The Company’s data portals, supporting hundreds of thousands of data transactions per day, have stored over 300,000 sample testing reports, and are now exchanging data with multiple third-party platforms.

About Colorcon®

Colorcon is a world leader in the development, supply and technical support of formulated film coating systems, modified release technologies, and functional excipients for the pharmaceutical industry. Colorcon’s best-in-class products and technologies are complemented by Colorcon’s extensive application data and value-added services to support all phases of solid oral dose design and development. Colorcon’s focus on market issues and technology development has earned Colorcon an international reputation as a pharmaceutical supplier of choice. That reputation is based on the superior product quality, unparalleled technical support, extensive regulatory assistance and reliable supply from multiple locations.

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and DNA mass production for diagnostics, personalized medicine and therapeutics.

Applied DNA makes life real and safe by providing innovative, molecular-based technology 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. The proprietary DNA-based "CertainT®" platform can be used to identify, tag, test, and track products, to help assure authenticity, origin, traceability, sustainability and quality of products.

SigNature® DNA describes the core technology ingredient that is at the heart of a family of uncopiable, security and authentication solutions, targeted a wide range of industries, including but not limited to, pharmaceuticals and nutraceuticals, textiles and defense materials , BackTrac® and DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful track-and-trace. Our products provide a forensic chain of evidence in large commercial ecosystems

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Forward-Looking Statements

The statements made by Applied DNA 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 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 our lack of significant revenues, limited financial resources, limited market acceptance, history of net losses, market competition, risk of not obtaining regulatory approval 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 28, 2017 and our subsequent quarterly report on Form 10-Q filed on February 8, 2018, 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 to reflect the occurrence of unanticipated events, unless otherwise required by law.

Contact information

Investors:
LHA Investor Relations
Sanjay M. Hurry, 212-838-3777
shurry@lhai.com
or
Media:
DGI Comm
Cheryl Schneider, 212-825-3210
cschneider@dgicomm.com
or
Program:
Applied DNA Sciences, Inc.
James A. Hayward, 631-240-8800
Chief Executive Officer
james.hayward@adnas.com
web:  www.adnas.com
twitter: @APDN

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Manchester United and True Religion Launch Denim Range19.10.2018 20:37Tiedote

Manchester United (NYSE:MANU) and luxury denim brand True Religion have collaborated to launch a range of premium club branded denim wear. A first for the club, the new global partnership with the iconic American denim brand will see a range of men’s & women’s co-branded styles go on sale beginning 26th October in the club’s Megastore as well as online via United Direct and truereligion.com & eu.truereligion.com. The exclusive collection features jeans, shirts and jackets, including a highly desirable limited edition denim jacket embroidered with the club’s crest. Fans will have the opportunity to win a selection of clothing from the new range by visiting www.manutd.com/truereligion. Manchester United’s Group Managing Director, Richard Arnold, comments: “True Religion is a well-known, established name in fashion, creating unique designs without compromising on quality. The range we have collaborated on includes the same attention to detail and craftsmanship that has made True Religion

Arch Insurance Announces Strategic Leadership Changes19.10.2018 16:10Tiedote

Arch Insurance today announced that Matt Shulman will assume the newly created role of CEO, Arch Insurance North America, effective January 1, 2019. In this role, he will lead Arch Insurance’s operations in the United States and Canada. He will report to Nicolas Papadopoulo, Chairman and CEO of Arch Worldwide Insurance Group. Mr. Shulman, who has more than 20 years of experience in the insurance industry, has been with Arch Insurance since 2009 and has served as the President and CEO of Arch Insurance Europe since 2016. “Matt brings significant U.S. and international experience to this role. Under his leadership, together with our senior team, Arch Insurance will continue to enhance our value proposition to our customers through a robust, diversified product portfolio, creative solutions and excellent service,” Mr. Papadopoulo said. Arch Insurance has also created a new organizational structure with three Chief Underwriting Officers (CUO) dedicated to specific lines of business. These

Takeda to Present Results from Phase 3 ALTA-1L Trial Highlighting Intracranial Efficacy of ALUNBRIG® (brigatinib) Versus Crizotinib in First-Line Advanced ALK+ Non-Small Cell Lung Cancer19.10.2018 15:00Tiedote

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that intracranial efficacy data from the Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1 st Line) trial showed improved intracranial progression-free survival (PFS) and intracranial objective response rate (ORR) with ALUNBRIG (brigatinib) compared to crizotinib among anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) patients. Data for these secondary endpoints will be presented in a poster discussion at the European Society for Medical Oncology (ESMO) 2018 Congress on Friday, October 19 at 2:00 p.m. CET in Munich, Germany. These results further support ALUNBRIG as a potential treatment for adults with ALK+ locally advanced or metastatic NSCLC who had not received a prior ALK inhibitor. ALUNBRIG is currently not approved as first-line therapy for advanced ALK+ NSCLC. “ALK+ NSCLC often spreads to the brain, so having options that can clearly demonstrate efficacy both in the brain an

Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) to Treat Patients With Cystic Fibrosis Aged 12 to <24 months With Certain Mutations in the CFTR Gene19.10.2018 14:54Tiedote

Vertex Pharmaceuticals (Europe) Limited today announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for KALYDECO® (ivacaftor) to include the treatment of people with cystic fibrosis (CF) aged 12 to <24 months who have at least one of the following nine mutations in their cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. If the European Commission issues a favorable adoption of the EMA CHMP opinion for the extension of indication, ivacaftor will be the first and only medicine approved in Europe to treat the underlying cause of CF in patients aged 12 to <24 months, who have specific mutations in the CFTR gene. “Cystic fibrosis is a chronic, progressive disease that is present at birth, with symptoms often occurring in infancy, so early treatment is crucial to deliver the best possible outcomes for patients,” said Reshma Kewalr

Tradeshift Announces Q3 2018 Results19.10.2018 14:00Tiedote

Tradeshift, the leader in supply chain payments and marketplaces, today announced results from the third quarter of 2018, marking the tenth quarter in a row of successive growth and beating targets. Tradeshift’s third quarter growth stats announced today include: YoY revenue grew 400 percent (trailing 12 months) YoY new bookings grew 284 percent YoY gross merchandise volume (GMV) grew 262 percent New total contract value grew by $47M in Q3 Tradeshift’s customer roster continued strong growth this quarter adding 27 new customers, including Hertz, Shiseido, ECU, and Fortune 500 leaders in retail apparel, agriculture, engineering and construction, hospitality, travel and food delivery. Tradeshift also expanded its app ecosystem by adding a key partnership with Coface, a global credit insurer. Coface has announced a new app solution on the Tradeshift platform offering risk and business information services to help businesses make decisions by ensuring greater financial transparency between

Schlumberger Announces Third-Quarter 2018 Results19.10.2018 14:00Tiedote

Schlumberger Limited (NYSE: SLB) today reported results for the third quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Sept. 30, 2018 Jun. 30, 2018 Sept. 30, 2017 Sequential Year-on-year Revenue $8,504 $8,303 $7,905 2% 8% Pretax operating income $1,152 $1,094 $1,059 5% 9% Pretax operating margin 13.5% 13.2% 13.4% 36 bps 15 bps Net income - GAAP basis $644 $430 $545 50% 18% Net income, excluding charges & credits* $644 $594 $581 8% 11% Diluted EPS - GAAP basis $0.46 $0.31 $0.39 48% 18% Diluted EPS, excluding charges & credits* $0.46 $0.43 $0.42 7% 10% North America revenue $3,189 $3,139 $2,602 2% 23% International revenue $5,215 $5,065 $5,147 3% 1% North America revenue, excluding Cameron $2,572 $2,546 $2,086 1% 23% International revenue, excluding Cameron $4,559 $4,387 $4,430 4% 3% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. Schlumberger Chairman and CEO Paal Kibsgaard commented, “Our third

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme