18 November 2013, Toronto, Ontario – Hillcore Life Sciences is pleased to announce that CardioPharma’s lead product, a patented triple-combination once-daily Cardiovascular Disease (CVD) capsule, has successfully completed the FDA required pharmacokinetic study. Acquired in December 2011, Hillcore Life Sciences, through Cardio RX Ventures Canada, owns the exclusive rights to CardioPharma’s lead product in the United States of America, Canada, Australia, New Zealand, South Africa, and Israel.
“The recently completed pharmacokinetic study clearly demonstrates that CardioPharma’s lead product is very much a reality and a few shorts steps from an NDA filing. The outstanding results of our pharmacokinetic study coupled with demonstrable product stability data and commercial scale up abilities set the stage for our upcoming pharmacodynamic study,” stated Don Sellers, CardioPharma’s Chairman and CEO. The planned pharmacodynamic study and characterization of food effects for labeling are the last studies for CardioPharma’s lead product prior to NDA submission.
In its pharmacokinetic study, CardioPharma’s once-daily triple-combination CVD product contained a blood pressure lowering medicine, a lipid lowering medicine and an anti-coagulant was compared to equivalent doses of co-administered ZESTRIL® Tablets, ZOCOR® Tablets, and Bayer® Aspirin Tablets under fasted conditions in healthy adult male and female subjects. The end point of the study confirmed that the CardioPharma combination product achieved blood levels of active ingredients comparable to the blood levels of the reference drug.
The CardioPharma CVD product is specifically designed to treat both high blood pressure and high cholesterol (two important considerations in cardiovascular disease) while ameliorating the major patient concern of cost and the doctor’s concern with compliance, or patients taking medications as prescribed. CardioPharma’s CVD product would offer the patient an equal but more convenient way to take their CVD medicines as prescribed. Don Sellers noted, “CardioPharma intends to explore the relationship of improved compliance to improved clinical outcomes in post marketing studies.” After FDA approval, the product would be available in four different dose ranges to accommodate the majority of CVD patients already taking these three types of medicines. CardioPharma’s platform patents issued in major markets around the globe permit the development of a wide range of CVD combination products
Charles Bon, President of Biostudy Solutions, the statistical analysis company that independently compiled the results, commented, “The positive PK results of this study also demonstrate that the capsule as planned and designed in the laboratory works as expected in human subjects. Specifically, it confirms that the formulation of the product is correct with respect to the components selected and the ratios of the active ingredients to excipients.”
About CardioPharma:
CardioPharma (www.cardio-pharma.com) is a Wilmington, NC, based specialty pharmaceutical company focused on combinatorial cardiovascular medicine.
About Hillcore Life Sciences:
Hillcore Life Sciences, part of the Hillcore Group, partners with leading innovative life science companies for the development of their drugs or medical technologies. The Hillcore Group is a leading independent Canadian investment and advisory firm. The Group has offices in Toronto, Vancouver, Calgary and Montreal. Through our various groups and portfolio companies Hillcore employs more than 1,860 people throughout Canada. Entities under its management have an asset value in excess of $3.1 billion, as of December 31, 2012.
Zestril® is a registered trademark belonging to AstraZeneca Pharmaceutical for lisinopril an angiotensin converting enzyme (ACE) inhibitor.
Zocor® is a registered trademark belonging to Merck & Company for simvastatin, an HMG-CoA reductase inhibitor.
Bayer Aspirin, is a registered trademark belonging to Bayer Pharmaceutical for aspirin. Aspirin is also known by the generic term, acetylsalicylic acid (ASA).