When the FDA recently announced that it is considering a faster approval process for developers of drugs for serious diseases, it was important news for companies like Cardium Therapeutics, a San Diego-based health sciences and regenerative medicine developer. Development of a significant new drug is expensive and time consuming even without the regulatory requirements, and pressure has been mounting on the FDA to make the process more efficient. The goal of the new process is to allow quicker clinical trials, while also letting physicians administer the drugs to critical need patients where the benefits would outweigh the risks.
But pharmaceutical developers like Cardium are often not focused on the U.S. alone. Major markets can exist in other parts of the world where a given drug may fit special needs and conditions. In the case of Cardium, one of their lead products is Generx, a DNA-based angiogenic growth factor therapeutic designed to stimulate blood vessel growth around the heart. In places where costly and invasive surgical revascularization procedures, such as coronary artery bypass surgery and angioplasty/stents, may not be feasible, the kind of innovative and cost-effective treatment Generx represents is a good match.
It is expected that 80 percent of future increases in coronary heart disease will occur outside the United States, representing a significant opening for Cardium and Generx. Cardium CEO, Christopher Reinhard, recognizes the opportunity: "We believe that Generx may offer the potential for a one-time, non-surgical cost-efficient treatment option for patients with myocardial ischemia due to coronary artery disease."
In June, Cardium announced that it had received clearance from the Russian Ministry of Health and Social Development to start the phase III registration study for Generx. The Russian Health Authority will brand Generx with the therapeutic drug trade name Cardionovo for purposes of marketing.
For additional information, visit www.CardiumTHX.com
Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html