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Subject ViroMed’s PG201 receives market approval
Writer ViroMed
Date 2012/04/06

SEOUL, KOREA, April 6 – ViroMed Co., Ltd. (KOSDAQ: 084990:KS) today announced that it has received NDA approval from the Korea Food and Drug Administration (FDA) for its lead product PG201 for the treatment of osteoarthritis. With this, PG201 gets the title of being ViroMed’s first drug product and Korea’s 7th phytotherapeutic drug to receive the final approval.

PG201 is comprised of herbal extracts well recognized in oriental medicine for their effects in arthritis. These herbs have been known to be efficacious at improving blood circulation, fortifying muscles and bones, strengthening joints and regenerating damaged tissues.

Pre-clinical studies have showed that PG201 suppressed the production of inflammatory mediators such as IL-1b and TNF-alpha, prevented the cartilage degradation by MMP, and increased the expression of TIMP-2. These actions resulted in anti-inflammatory, cartilage protective and pain-relieving effects. These results have been published on a number of renowned international journals including Rheumatology. Also, based on the results from the Phase III trial conducted in 12 locations in Korea including Seoul National University Hospital, PG201 were proved to produce near-to-none side-effects and excellent pain-relieving effects. This makes a striking contrast to pre-existing drugs, because almost all of them exhibit side-effects such as gastrointestinal tract problems, edema, and circulatory system problems. Also, as PG201 is derived from herbs, it is suitable for long-term use as in treating for arthritis, and scientists of ViroMed are also expecting to see other therapeutic effects from this botanical drug.

PG201 will be marketed by a partner company PMG Pharmaceutical (private), under the brand name “Layla”. ViroMed will receive undisclosed amount of royalties on sales. It is a capsule that is taken orally twice-a-day. Its market launch in Korea is expected in the second half of this year. Also, ViroMed and PMG are planning to launch their product in worldwide markets such as China and the EU countries.

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About Osteoarthritis market
As the population is rapidly aging, the number of patients seeking treatment for osteoarthritis is rising exponentially. According to IMS Data’s research, the size of the osteoarthritis market in Korea was about 340 billion KRW in 2009, and the growth rate reaches approximately 10%.