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CardioPharma Triple Combination CVD Capsule Shows Bioequivalence

2013年11月22日 AM04:40
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WILMINGTON, N.C.

The lead product for CardioPharma, a patented triple-combination once-daily Cardiovascular Disease (CVD) capsule, has successfully completed the FDA required pharmacokinetic study.

“This study clearly demonstrates the lead product for CardioPharma is a reality and a few shorts steps from 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 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, containing 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 cardiovascular disease considerations) while ameliorating the major patient concern of cost and physician concern with compliance, or patients taking medications as prescribed. This 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 classes 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.

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).

Forward looking statement

The information in this press release contains forward-looking statements including the prospective development, commercialization and regulatory approval of CardiaPill 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 successfully complete its pharmacodynamic study and submit an NDA.

CONTACT

CardioPharma
Dr. Daniel Gregory, +1-910-794-1834
or
Media,
INDIVO
Al
Buscaino, +1-954-919-7000 x222

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