CardioPharma Prepares for FDA Submission

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Thu Oct 8, 2009 4:53pm EDT

World's First Patented Triple-Combination CardiaPill®







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

CardioPharma, Donald R. Sellers, +1-650-773-4804, and Dr. Daniel Gregory,
+1-910-794-1834; or Media, INDIVO, Al Buscaino, +1-954-919-7001 x222
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