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Subject Approval from the Korea FDA for a Phase II clinical trial for diabetic peripheral neuropathy
Writer ViroMed
Date 2012/04/13

SEOUL, KOREA, Apr. 12 – ViroMed Co., Ltd. (KOSDAQ: 084990:KS) today announced that VM202-DPN, the company's proprietary DNA medicine being developed in cooperation with Reyon Pharmaceutical Co., Ltd., has received approval from the Korea FDA for a Phase II clinical trial for diabetic peripheral neuropathy (DPN).

Its great potential has already been shown by the groundbreaking results from the Phase I/II clinical trial conducted in the US which confirmed the safety as well as the efficacy of VM202-DPN. Only two injections (at 2-week intervals) produced prolonging pain-reduction effects which were still lasting by the end of the 1-year follow-up period. ViroMed received approval for Phase II trial last year in the US based on these exciting and promising Phase I/II results. John A. Kessler, MD., of Northwestern Memorial Hospital, Chicago, US, will be the principal PI of this multinational Phase II study, and a total of 100 patients will be enrolled to evaluate the efficacy of VM202-DPN. About 7 hospitals in the US including Northwestern Memorial Hospital, Beth Israel Deacons Medical Center (Harvard Univ.), and the Mount Sinai Hospital, and 4-5 hospitals in Korea including Yonsei Univ. Severance Hospital will be participating for this study.

“This is an exceptional case among Korea’s new drug development biotech companies.” commented Jong-Mook Kim, the Director of Clinical Development Department of ViroMed. “Pre-existing drugs are only effective for temporary pain-relief and not without serious side-effects. With VM202-DPN’s disease-modifying capabilities which would enable us to provide the fundamental cure for DPN patients, VM202-DPN will set a new trend in the current analgesic-driven diabetic neuropathy market.”

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.
About VM202-DPN

VM202-DPN is ViroMed’s proprietary DNA medicine using Hepatocyte Growth Factor (HGF), a gene that stimulates the growth of arteries. Recent experiments have shown that HGF also stimulates the growth and recreation of nerve cells, which raises exciting possibilities as a therapeutic for diabetic peripheral neuropathy. VM202-DPN has also been designed to have minimal side effects and to safely disappear from the body after its intended therapeutic effect has been produced.

About Diabetic Peripheral Neuropathy (DPN)

Diabetic neuropathy is a common complication that affects 60 to 70% of patients with type 2 diabetes, a form of diabetes mellitus that accounts for half of all cases. Diabetic peripheral neuropathy is a form of the disease that affects the nerves in the leg and causes intense pain and difficulty in movement. If left untreated, it can lead to ulcers and, in the worst cases, amputation.

Diabetic peripheral neuropathy is characterized by the impairment of functions in nerve cells due to a high blood-sugar level in the patient’s blood which leads to the cells’ deaths, and is further accelerated by damage to peripheral arteries from other complications. Therefore, a key component of treating this disease is the recovery of damaged nerve cells and the regrowth of peripheral arteries; however, there is no such fundamental cure currently available. The occurrence of the disease can only be minimized by controlling the blood-sugar level through a healthy diet, while symptoms can only be eased through supplemental treatments such as pain-killers and physical therapy.

There are about 143 million people affected by diabetic neuropathy worldwide. In the US alone, 3.9 million people are affected.

Diabetic Peripheral Neuropathy market
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)
According to Pelham Smithers Associates, an UK consulting firm specialized in data analysis, the sales of existing medicines currently used to treat diabetic neuropathy were $15 billion in 2009. After disease-modifying drugs like VM202-DPN are out to the global market (estimated launching year: 2016), it is forecast that the size of the market will be $2.5 billion in 2017, and grow to $5 billion in 2020.

Competitiveness of VM202-DPN
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.

About ViroMed

ViroMed Co., Ltd. is a leading biotechnology company located in Seoul, Korea with a US presence in Atlanta and the San Francisco Bay Area. The company has two main areas of focus: DNA/protein-based biopharmaceuticals and phytotherapeutics (botanical drugs/nutraceuticals). ViroMed now has five main products in its pipeline targeting cardiovascular disease, cancer, and immune-related disorder, with clinical trials ongoing in the US, Korea, and China. To learn more about the company and its products, visit www.viromed21.com.