ViroMed Receives US FDA Approval for Collaborative Biopharmaceutical
SEOUL, KOREA, Mar. 10 - ViroMed Co., Ltd. (KOSDAQ: 084990) today announced that the company has received an approval from the US FDA for a Phase I/II trial for VM202-CAD, a heart disease medicine being jointly developed with Biologics Delivery Systems Group, Cordis Corporation, a Johnson & Johnson Company.
The successful completion of the first step of the collaborative development between the Korean biotech company and the medical device company comes only a year after the deal was first announced in March 2008. Biologics Delivery Systems Group entered into a contract for ViroMed's VM202-CAD after a search for a therapeutic for the treatment of myocardial infarction and angina pectoris that could be administered using their cardiac navigation system and catheter without requiring major surgery. For the past year, the safety and efficacy had been inspected at Texas Heart Institute before an IND application was finally submitted by the company and approved by the FDA. The trial will be for patients with angina pectoris and will take place at various medical centers designated by Cordis, such as Northwestern Memorial Hospital in Chicago and Minneapolis Heart Institute.
"A Korean biotech company with three IND approvals in the US is unprecedented," said Dr. Sunyoung Kim, CEO of ViroMed. "The approval of a clinical trial being developed with a global company raises the value of our new drug candidate."
About VM202-CAD
VM202-CAD is a gene medicine for the treatment of myocardial infarction and angina pectoris that creates new blood vessels around the heart's main coronary arteries, renewing the supply of blood and regrowing cells in the heart muscle. The medicine is being developed to treat the fundamental causes of coronary heart disease, resulting in thicker walls of the heart and a stronger pumping action. The same medicine is being developed in Korea with Reyon Pharmaceutical Co., Ltd. under the name VM202RY as a direct injection to the heart, with the clinical trial ongoing at Seoul National University Hospital. The efficacy has been confirmed and the results were presented in November 2008 to The Korean Society for Thoracic & Cardiovascular Surgery and the Korean Society of Gene Therapy.
The clinical trial in the US is distinct from the Korean clinical trial in that Cordis' NOGA® XP Cardiac Navigation System allows for the administration of VM202-CAD without resorting to major surgery. There are two steps, the first of which requires the additional use of the NOGASTAR® Mapping Catheter. A 3-D image of the patient's heart is produced by travelling up through the leg artery and into the heart. After a physician examines the image and ascertains the areas in need of treatment, the second step, which involves using the MyoStarTM Injection Catheter to deliver VM202-CAD to the heart through the same leg artery, is implemented.
About Myocardial Infarction and Angina Pectoris
Myocardial infarction occurs when any one of the main coronary arteries in the heart are acutely blocked, causing damage or death to the heart muscle. Angina pectoris is chest pain caused by a decrease in the supply of blood to the heart muscle due to a sudden or chronic obstruction of a coronary artery.
According to Heart Disease and Stroke Statistics 2008 published by the American Heart Association, 8.1 million Americans have myocardial infarction and 9.1 million have angina pectoris. Almost half a million deaths are attributed to coronary heart disease each year, which are almost as many deaths caused by cancer. The estimated medical cost associated with coronary heart disease is almost $160 billion in the US alone.
About ViroMed
ViroMed Co., Ltd. is a biotechnology company located in Seoul, Korea, focusing on gene and protein-based therapeutics for various diseases. ViroMed now has four lead products in development targeting cardiovascular disease, cancer, and genetic disease. To learn more about the company and its products, visit www.viromed.co.kr.