City of Industry, CA August 21, 2017 – Marina Biotech, Inc. (OTCQB: MRNAD) (‘Marina’ or the ‘Company’) a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for disease intersections of arthritis, hypertension, and cancer, today announced that its manufacturing partner, Windlas Healthcare Limited (‘Windlas’), has agreed to invest $2 million in working capital to support Marina Biotech’s manufacturing initiatives of its marketed product and its pipeline. In March of 2017, the Company signed a definitive manufacturing agreement with Windlas.
Joseph W. Ramelli, CEO of Marina Biotech, commented, “We are very pleased that Windlas Healthcare has broadened our initial definitive manufacturing agreement with a $2 million working capital investment. It is a testament to their belief in our vision. The investment will reduce the amount of capital needed for the company to execute on its plans. Marina is at a critical inflection point and uniquely positioned to move forward quickly through commercialization and clinical testing for the often neglected disease intersection of pain and hypertension.”
About Windlass Healthcare Limited
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. For more information please visit www.windlashealthcare.com.
About Marina Biotech, Inc.
Marina Biotech’s focus is to treat the intersection of arthritis, pain, hypertension, and oncology diseases using combination therapies of already approved drugs. Marina’s first FDA approved drug, Prestalia®, contains perindopril arginine, an ACE inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, and is indicated for the treatment of hypertension to lower blood pressure. The company is developing and commercializing late stage, non-addictive pain therapeutics. The company’s ‘next-generation of celecoxib,’ including IT-102 and IT-103, are designed to control the dangerous side-effect of edema that prohibits the drug from being prescribed at higher doses. These have the potential of replacing opioids and combatting the opioid epidemic. Additionally we are developing therapeutic microbiome using the only orally bioavailable siRNAs platform against FAP and IBD. Additional information about Marina Biotech is available at http://www.marinabio.com.
Prestalia contains perindopril arginine, an ACE inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, and is indicated for the treatment of hypertension to lower blood pressure. Prestalia may be used in patients whose blood pressure is not adequately controlled on monotherapy. Prestalia may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine and the ACE inhibitor class to which perindopril principally belongs.
FDA approval of Prestalia was based on data from the 837-patient Phase III PATH trial (Perindopril Amlodipine for the Treatment of Hypertension). The study demonstrated that the fixed-dose combination of perindopril arginine with amlodipine besylate in a single pill was significantly better than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. It also suggested that the combination may provide a better benefit/risk ratio than either treatment alone.
About IT-102 & IT-103
IT-102 and IT-103 as our next generation celecoxib for management of arthritis pain. IT-102 targets a population requiring angiotensin converting enzyme (“ACE”) inhibitors such as lisinopril and IT-103 targets a population requiring olmesartan. The initial approval based on pivotal bioequivalence (“BE”) trial and a small phase III trial will be for combined arthritis pain and hypertension for patients already taking both drugs. Exploiting the suppression of celecoxib induced edema, we anticipate that these FDCs can eventually replace all of celecoxib prescriptions with or without hypertension once our phase III trial is completed with positive demonstration of edema suppression. This trial will be conducted post approval for label change and will target the highest edema risk patients- the elderly patients whose pill burden is greater than five per day. The inherent lower risk of gastrointestinal (“GI”) bleeding with celecoxib makes it likely that IT-102 and IT-103 can also capture market shares of other pain medications such as ibuprofen and indomethacin.
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.
KCSA Strategic Communications
Valter Pinto, Senior Vice President
PH: (212) 896-1254