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CardioPharma Prepares for FDA Submission
Date:10/8/2009

WILMINGTON, N.C., Oct. 8 /PRNewswire/ -- CardioPharma is beginning the final funding phase before submitting an 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," stated Don Sellers, CardioPharma's Chairman and CEO. "After our recent meeting with the FDA we believe the CardiaPill NDA can be submitted within twelve 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," noted Dr. Carlos Ferrario, Professor of Hypertension and Vascular Diseases at Wake Forest University, an advisor 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." He added, "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."

CardioPharma's own 170,000+ patient data base mirrors the results published by Kaiser Permanente. "We're also delighted with the positive support and guidance of such organizations as the FDA and WHO which recognize the potential of what CardioPharma is doing," added Sellers.

Dr. Frank Snyder, CardioPharma's Chief Medical Officer, noted, "When CardiaPill is approved by the FDA, the implications for global cardiovascular healthcare will be staggering. There is a well recognized unmet need for a cardiovascular product that both simplifies and enhances compliance." Dr. Daniel Gregory, CardioPharma's COO, added, "CardiaPill is a product which is less expensive for everyone - fewer co-pays, one dispensing fee, less paperwork and ultimately reduced hospitalization."

CardioPharma, while ahead in the US polypill race, is not alone in the competition to put a cardiovascular polypill into the market place. 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 UK first noted the need for such products, researchers around the world have sought without success to develop a practical polypill.

The CardioPharma team accepted the global polypill development challenge several years ago and is the only group in the race that has the advantage of two issued Harvard patents. CardioPharma also has the advantage of working with a distinguished product development team which includes one of the patent authors. CardioPharma judiciously collected data on thousands of patients and built a regulatory strategy with the guidance of the FDA to enable the product to be registered first in the US and then to be registered and distributed globally.

According to Mr. Sellers, who has over 35-years experience in pharmaceutical management, "The road to success is challenging. We all can recognize the need for a combination drug that data now suggests can reduce cardiovascular events by more than 60%, but we also had to make CardiaPill profitable." CardioPharma continues to persevere, recognizing that even a small percentage of the two $20 Billion+ cardiovascular markets in the US and EU is enticing. Notes Mr. Sellers, "CardiaPill is positioned to be a better economic and medicinal choice for all concerned compared to buying the three individual component medicines. We are not building an expensive product, but rather a single, daily dose pill containing a group of gold standard proven generics with the added benefit of reducing issues with what many claim to be one of the biggest problems in medicine: compliance."

About CardioPharma: CardioPharma (www.cardio-pharma.com) is a Wilmington, NC, based specialty pharmaceutical company focused on combinatorial cardiovascular medicine.

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 raise sufficient funds to complete its PK and PD studies.

SOURCE CardioPharma


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