City of Industry, CA – March 28th, 2017 – Marina Biotech, Inc. (OTCQB: MRNA), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for disease intersections of arthritis, hypertension and cancer, today announced that it has signed a definitive agreement with Windlas Healthcare Limited for the manufacture of its IT-102 fixed-dose combination (FDC) bi-layer tablets.
“This agreement marks the culmination of an in-depth due diligence and qualification process, during which we evaluated dozens of manufacturers, and Windlas came out ahead,” stated Joseph Ramelli, CEO of Marina Biotech. “The manufacturing of the FDC bi-layer tablets requires additional equipment and expertise that Windlas possesses. Now with this agreement in place we are positioned to move into a pivotal phase 3 clinical study by the first quarter of 2018.”
Marina Biotech’s IT-102, a celecoxib and lisinorpril FDC, is being developed for the combined treatment of arthritis and hypertension. The preference for and improved compliance with a single tablet makes the proposed FDC formulation a very useful drug for treatment of 2 common conditions with increasing frequency in the aging population. Additionally, the combination of lisinopril with celecoxib may reduce the incidence of cardiovascular adverse events and edema associated with celecoxib treatment, potentially making it a preferred treatment for pain. IT-102 will be further developed for treatment of familial adenomatous polyposis (FAP).
Windlass Healthcare Limited (WHC) corporate headquarters is in Gurgaon, India. The company was established in 2008 in Dehradun, and the manufacturing facilities are designed as per the US Food and Drug Administration (US FDA), and European Union current Good Manufacturing Practices (EU cGMP) standards. The manufacturing plant has received approval from USFDA.
About Marina Biotech
Marina Biotech is a biotechnology company focused on the development and commercialization of innovative therapeutics for disease intersections of arthritis, hypertension, and cancer. Our pipeline includes combination therapies of oligonucleotide-based therapeutics and small molecules. The Marina Biotech pipeline currently includes a clinical program in Familial Adenomatous Polyposis (a precancerous syndrome). By its merger with IthenaPharma, Marina Biotech recently acquired IT-102/IT-103 – next generation celecoxib – which will be developed together with CEQ508 as a therapeutic enhancer for therapies against FAP and CRC. IT-102/IT-103 are also being developed for the treatment of combined arthritis/ hypertension and treatment of pain requiring high dose of celecoxib. Additional information about Marina Biotech is available at http://www.marinabio.com.
Marina Biotech Forward-Looking Statements
Statements made in this news release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Marina Biotech to successfully integrate its business operations with those of IthenaPharma; (ii) the ability of Marina Biotech to obtain funding to support its clinical development; (iii) the ability of Marina Biotech to attract and/or maintain manufacturing, research, development and commercialization partners; (iv) the ability of Marina Biotech and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (v) the ability of Marina Biotech and/or a partner to obtain required governmental approvals; and (vi) the ability of Marina Biotech and/or a partner to develop and commercialize products prior to, and that can compete favorably with those of, competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Marina Biotech’s most recent filings with the Securities and Exchange Commission. Marina Biotech assumes no obligation to update or supplement forward-looking statements because of subsequent events.