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Subject China approves Viromed`s VM202 clinical trial for Peripheral Artery Disease
Writer ViroMed
Date 2008/06/30
Clinical trials for Peripheral Artery Disease will commence in China, projected to be the 5th largest pharmaceutical market in the world by 2010.
This is the company’s second clinical trial approval in China following VM501.

ViroMed Co., Ltd. (listing: KOSDAQ, CEO: Sunyoung Kim) is proud to announce that VM202, a gene-based medicine for Cardiovascular Disease (CVD), has been approved by China’s State Food and Drug Administration (SFDA) for clinical trials.

With the promise of VM202’s blockbuster potential, ViroMed has already started clinical trials in both the US and Korea. The SFDA’s approval allows ViroMed to penetrate into what is projected to be the world’s 5th largest pharmaceutical market, positioning itself to be a major world-wide therapeutic.

Due to an unbalanced diet, lack of exercise, and smoking, the number of Chinese with CVD was 30 million in 2004, with more than 2 million of them dying from the disease every year (Chinese Academy of Science). The gene therapy market in China is projected to be US$ 700 million in 2010 and US$ 1.3 billion in 2015 (Jain PharmaBiotech, 2006), with ViroMed’s VM202 expected to possess 30% of the CVD gene therapy market.

The clinical trial will be conducted by ViroMed’s China partner Beijing Northland Biotech for Peripheral Artery Disease (PAD, a form of CVD affecting limbs) such as critical limb disease from diabetes and hardening of the arteries. ViroMed anticipates an expeditious result with the cooperation of the proper Chinese authorities and hospitals where the clinical trials will be held.

ViroMed is already conducting a phase II trial in China for VM501, a recombinant protein that can be used for the treatment of thrombocytopenia (abnormally low level of blood platelets). “The company has been successfully running clinical trials in China,” says Sunyoung Kim, the CEO of ViroMed. “This new trial with VM202 is expected to further strengthen its position in the world’s most populous country. ViroMed is poised to be a leader in the Chinese market as we are the only Korean biotech company performing clinical trials in China with our own innovative biotherapeutics, not just with generic drugs.”

Reference

VM202, gene-based medicine for CVD – clinical tests and phases by country
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Korea
Target Disease: CAD, clinical trial approval in October 2006
Currently in Phase I, in cooperation with Reyon Pharmaceutical Co. and Seoul National University’s Department of Thoracic and Cardiovascular Surgery

USA
Target Disease: PAD, clinical trial approval in November 2006
Currently in Phase I, in cooperation with Minneapolis Heart Institute

China
Target Disease: PAD, clinical trial approval in June 2008
Phase I to start in the second half of 2008, in cooperation with Beijing Northland Biotech

VM202: gene-based medicine for myocardial infarction, angina, and critical limb disease
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Critical Limb Disease
Blockages of blood vessels in feet and legs leading to critical limb disease is present in 8 to 12 million people in the US alone, with the gene therapy market alone estimated at US$ 1.5 billion ("Pipeline Insight: PAD", Datamonitor, 2004).

Coronary Artery Disease (CAD): myocardial infarction / angina
CAD is the leading cause of death in developed countries, with the world-wide death rate rising every year. It is estimated that 16 million Americans have CAD’s such as myocardial infarction and angina. Currently, surgeries include bypassing dead arteries using transplanted leg arteries or using stents to widen narrowed arteries. However, these procedures are often restrictive and limited in their ability to address the root problem. The CVD gene therapy market, which is ViroMed’s main target market, is estimated to be US$ 3 billion by 2015. (“Gene Therapy”, Jain PharmaBiotech, 2006)

VM202: CVD gene-based medicine
VM202 is designed to address the root problem of CVD. It combines Naked DNA with HGF (Hepatocyte Growth Factor) which has shown effectiveness in facilitating angiogenesis, the growth of new blood vessels.