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Subject US FDA Approves VM202 for Phase III Clinical Study of Diabetic Peripheral Neuropathy (DPN)
Writer ViroMed
Date 2015/04/28

US FDA Approves VM202 for Phase III Clinical Study of Diabetic Peripheral Neuropathy (DPN)

□ VM202-DPN, an innovative drug for the treatment of diabetic peripheral neuropathy, has been approved by the US FDA for phase III clinical study
□ VM202-DPN is an innovative new biopharmaceutical that can induce the regeneration of damaged microvasculature and nerve cells
□ Differs from currently used pain killers by providing fundamental treatment for the disease

SEOUL, KOREA, Apr. 21 – ViroMed Co., Ltd. (KOSDAQ: 084990:KS) today announced that VM202-DPN, the company's proprietary DNA medicine for the treatment of diabetic peripheral neuropathy (DPN), has received approval from the US FDA for a Phase III clinical trial.
VM202-DPN is an innovative new drug that induces regeneration of damaged microvasculature and nerve cells. When VM202-DPN is injected, a protein called Hepatocyte Growth Factor (HGF) is produced around the injection sites, which induces the formation of new blood vessels and regeneration of nerve cells. The HGF protein produced can treat the extreme pain experienced by diabetic peripheral neuropathy patients. This pain relieving effect has been confirmed through phase I and II clinical study conducted in both the US and Korea.
ViroMed submitted phase III IND based on these results and received approval from US FDA without any additional modification. This indicates that the US FDA, once again, confirms the superb safety and efficacy profile of VM202-DPN. VM202-DPN phase III will be a double-blind study targeting diabetic peripheral neuropathy patients distributed between placebo and VM202-DPN treated groups. The total number of patients will be 477 and the efficacy evaluation will be based on comparison with the placebo group.
Mr. Yong Soo Kim (CEO) commented “If VM202-DPN phase III is successfully completed, it will be the first Korean biopharmaceutical to challenge entry into global market. Currently, we are considering partnership with a global pharmaceutical company to enter the global market.”. 
■ What is DPN?
DPN is one of the most common complications associated with diabetes patients. Due to high glucose level in the blood of diabetes patients, the microvasculature and nerve cells are damaged, which leads to extreme pain caused by abnormal signaling from the damaged nerve cells. In addition to pain, patients are known to suffer from sleep disorder, depression, and others. They also lose sense in their feet, which inhibits them from noticing injuries that leads to infection and formation of ulcers, and in extreme cases, amputation of the legs.   
■ Size of DPN patients
The number of diabetes patients in the world was estimated around 387 million in 2014, which is steadily increasing with a predicted diabetes patient population of 590 million in 2035 (International Diabetes Federation, 2014). 5~20% of this population are reported to suffer from DPN with pain (Diabetes Care 33:2285–2293, 2010). 
In the US alone, there are around 260 million diabetes patients, which includes an estimated 13~52 million (5~20%) painful DPN patients.
■ Current treatment options and drug market
Currently, there are no effective treatment methods for DPN. Glucose control through diet and foot care is being used to manage diabetes, which is the cause of the disease. Pain killers are used to alleviate pain for those with acute pain.

The size of pain killer market for DPN is estimated around $3.5 ~ 4 billion. 
- Pregabalin (Lyrica®, Pfizer 2013 total revenue: $4.5 billion -> 30~50% prescribed for DPN)
- Duloxetine (Cymbalta®, Eli Lilly, 2013 total revenue: $500 million -> 20~25% prescribed for DPN)
- Gabapentin (Neurontin®, Pfizer 2013 total revenue: $200 million)