WILMINGTON, N.C., December, 2015 – For Immediate Release – CardioPharma, Inc., a pioneer in the development of cardiovascular fixed dose combination products, recently completed its FDA submission batch manufacturing for its lead compound, CP-101, a single capsule combining the gold standards of cardiovascular medicine: an antihypertensive, a cholesterol modifying product and an anti-platelet agent.
The company intends to begin dosing patients in its pivotal pharmacodynamic (PD) study as early as the first quarter of 2016. The clinical study has received an FDA special protocol assessment and is designed to demonstrate the safety and efficacy of taking the three standard-of-care cardiovascular disease medicines together in a single night time dose.
Don Sellers, CEO of CardioPharma, observed, “Our successfully completed pharmacokinetic study is the keystone of our NDA filing and will be amplified by this PD study. We are pleased that FDA has reviewed our clinical plans and agrees with our proposed regulatory path. We are confident that CardioPharma, working together with its CRO partners and other consultants, now has in-hand the clinical program necessary to successfully file its lead New Drug Application (NDA).”
“CardioPharma’s capsule combines three of the most-used cardiovascular components into a single, once-a-day capsule,” added Frank Snyder, MS, MD. He continued, “By offering this convenience, the product is expected to enhance patient compliance, an issue that many consider to be the most important in medicine… many people simply don’t take their prescriptions. This product should help minimize this issue.”
Don Sellers also stated, “Our development interactions with major managed care organizations, the US Department of Veteran Affairs Hospitals, healthcare providers and distributors, as well as organizations such as the American College of Cardiology, have demonstrated an unparalleled, positive, broad based interest in getting this product on the market as soon as possible.”
CardioPharma has a strong IP portfolio with patents issued in the US, Europe and major international markets. CardioPharma’s goal is to help make these proven therapies available to the broader global population with the added benefits of convenience, improved compliance and cost savings across the board.
CardioPharma (www.cardio-pharma.com), Inc. is a specialty pharmaceutical company focused on cardiovascular fixed dose combination products. CardioPharma’s goal is to create unique, patent protected, global cardiovascular products that reduce the morbidity and mortality of the world’s number one killer – cardiovascular disease – in a cost-effective manner for all concerned. CardioPharma’s products are designed to provide superior clinical outcomes with economic benefits to patients, physicians, pharmacists and payors.
Forward Looking Statement
The information in this press release contains forward-looking statements including the prospective development, commercialization and regulatory approval in the U.S. and international markets. Words such as “expects,” “plans,” “believe,” “may,” “will,” “anticipated,” “intended” and variations of these words or similar expressions are intended to identify forward-looking statements. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors including the Company’s ability to raise sufficient funds to complete its PK and PD studies.