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CardioPharma Closer to NDA for Cardiovascular Disease Polypill
August 28, 2012 – For Immediate Release – CardioPharma, Inc., held a Scientific Advisory Board (SAB) meeting to guide preparations for the filing of the NDA for its lead product, a US manufactured CVD polypill. Also discussed were plans for additional products covered by the Company’s cardiovascular disease platform Intellectual Property. In addition to cardiologists and epidemiologists, consultants for quality, marketing, regulatory, manufacturing and other disciplines were in attendance.
Don Sellers, CEO of CardioPharma, observed, “Our upcoming Pharmacokinetics and Pharmacodynamics studies are the last requested steps prior to submission to FDA for approval of our polypill. CardioPharma’s polypill combines an anti-hypertensive agent, an anti-cholesterol agent and an anti-coagulant into a single capsule that will be made available in different dosage strengths to serve diverse patient needs. We are very pleased to be able to work with such an esteemed group of global thought leaders who share our vision for the importance of bringing this cost saving technology to U.S. patients, physicians and healthcare payers.”
According to the article, “Projected Impact of Polypill Use Among US Adults: Medication Use, Cardiovascular Risk Reduction, and Side Effects,” that appeared in the April 2011 issue of American Heart Journal, “the use of polypills among US adults at high risk for CVD has the potential to prevent millions of CHD and stroke events.”
“By combining well-accepted products in already-approved therapeutic doses, our lead product will provide patients already treated with the individual medications the convenience of taking one pill, once-a-day, while improving prescription compliance as well as offering savings on co-pays,” continued Sellers.
After the meeting, Carlos Ferrario, M.D., noted Cardiologist and Professor of Medicine at Wake Forest University, noted, “I am very pleased to be associated with this project to bring a true cardiovascular disease polypill to the US and international markets. This is a medicine presentation that is long overdue.”
CardioPharma has a strong IP portfolio with patents issued in the US, Europe, Canada and other international markets, as well as patents pending in the large Asian markets. CardioPharma’s goal is to provide a branded, patent protected product at near-generic prices 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.
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.
View CardioPharma Press Releases
- CardioPharma Targeting Q1 PD Study for Lead Drug Candidate Designed to Improve Compliance and Reduce Cost
- CardioPharma Triple Combination CVD Capsule Shows Bioequivalence
- CardioPharma Closer to NDA for Cardiovascular Disease Polypill
- CardioPharma Closes Financing Transaction
- CardioPharma Prepares for FDA Submission
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.