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Subject ViroMed receives approval for Phase II trial in the US for Diabetic Peripheral Neuropathy
Writer ViroMed
Date 2011/11/16

SEOUL, KOREA (Nov. 15, 2011) - ViroMed Co., Ltd. (KOSDAQ: 084990) today announced that VM202-DPN, the company's proprietary DNA medicine for treatment of Diabetic Peripheral Neuropathy, has received approval from the US FDA for a Phase II clinical trial.  

There are approximately 285 million diabetes patients around the world, 50% of whom are also suffering from diabetic peripheral neuropathy (DPN) as a complication of diabetes. The number of DPN patients reaches 3.9 million in the US alone. (Diabetes Research and Clinical Practice, 2010) 

Existing drugs prescribed for the treatment of DPN are mostly pain killers, and the most-often-used of all is Pfizer’s own “Lyrica” (worldwide sales of $1 bil/yr), a drug originally developed as epilepsy treatment. However, as “Lyrica” is the drug that temporarily relieves pain by blocking neurotransmitters, it must be used at twice-a-day basis for decades, and it is reported to produce nervous system-related side effects such as headache, insomnia and depression. Consequently, there have been high demands for safe and effective novel medicine for DPN as there are no fundamental treatments for it.  

To attend to those unmet needs, VM202-DPN is designed to treat the underlying disease by producing hepatocyte growth factor (HGF) that induces repair of damaged nerve cells and generation of micro-vessels in the affected regions of human body. Its great potential has already been shown by the resulting data from the Phase I/II clinical trial conducted in the US. It is reported that there were only 35% of the patients who experienced 50% or more reduction in pain level during clinical studies for “Lyrica”; however, 65% of the VM202-DPN treated patients experienced pain reduction only after two injections at 2-week intervals. Based on these exciting and promising results, the Phase II trial will enroll approx. 100 patients at a number of hospitals in the US including Northwestern Memorial Hospital in Chicago, and plans for a Phase II trial in Korea are also being put together. 

According to the UK consulting firm Pelham Smithers Associates, the sales of existing medicines currently used to treat diabetic neuropathy were $1.5 billion in 2009. Since these drugs are symptomatic treatments which can only alleviate symptoms temporarily but cannot cure the underlying disease, it is expected that their market will not grow to over $2 billion. On the other hand, it is forecast that the global launching of disease-modifying drugs like VM202-DPN (estimated launching year: 2016) will drive the explosive growth of the market, expanding to be over $3 billion in 2020, and reaching $12 billion in 2025.