CardioPharma Prepares for FDA Submission of Triple-Combination CardiaPill
October 9, 2009 – CardioPharma is beginning the final funding phase before submitting an FDA new drug application (NDA) for CardiaPill, the world's first patented triple-combination cardiovascular polypill.
"The recent news from Kaiser Permanente reinforces that in this cost containment and efficacy oriented healthcare environment, CardiaPill is in the right place at the right time," said Don Sellers, CardioPharma's chairman and CEO. "After our recent meeting with the FDA we believe the CardiaPill NDA can be submitted within 12 months following our final round of funding."
"The recently released results of the Kaiser Permanente ALL (aspirin, lisinopril, lovastatin) initiative provide clinical and economic insight into the significant need for effective, low-cost combination cardiovascular products," said Carlos Ferrario, M.D., professor of hypertension and vascular diseases at Wake Forest University, an adviser to CardioPharma and other cardiovascular interest groups. "What was even more remarkable," Dr. Ferrario added," is that this study showed positive results in two years, where prior studies viewing agents separately took five years to reach consistently positive results. This data shows that placing this combination of aspirin, ACE-I or ARB, and statin in one pill is an idea whose time has arrived, especially given these outcomes."
The company said there is a recognized unmet need for a cardiovascular product that both simplifies and enhances compliance, and CardiaPill is a product that is less expensive with fewer copays, one dispensing fee, less paperwork and ultimately reduced hospitalization.
CardioPharma is not alone in the competition to put a cardiovascular polypill into the marketplace. In Asia, Cipla and Dr. Reddy's have been trying for years and in Spain a group working with Ferrer Laboratories discussed clinical trials in Latin America in 2008. Since Wald and Law in the U.K. first noted the need for such products, researchers around the world have sought without success to develop a practical polypill.
For more information: www.cardio-pharma.com