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Subject DPhil. Sunyoung Kim, CSO of ViroMed, "Our gene therapy research is sailing through, and we are preparing for commercial production."
Writer ViroMed
Date 2017/09/12

DPhil. Sunyoung Kim, CSO of ViroMed,

"Our gene therapy research is sailing through, and we are preparing for commercial production."


Looking ahead to BLA in 2021 … discussing licensing out opportunities with big pharmas

 

 

http://img.hankyung.com/photo/201709/AA.14671181.1.jpgSEOUL, Korea – DPhil. Sunyoung Kim (pictured), first generation bio-venture company ViroMed’s CSO and R&D Director, announced on September 5th that preparations for the commercialization of VM202, the company’s flagship gene therapy medicine, are cruising along, full speed ahead. “Over the last six months,” he said, “we’ve brought a significant number of new hires onboard. I would say we were concentrating entirely on research thus far, and now we’ve just stepped into the production stage.” The company is currently conducting phase III trials for diabetic peripheral neuropathy and diabetic non-healing ischemic foot ulcers, as well as phase II trial for Lou Gehrig’s disease, all in the US.

Some 30 new employees have joined ViroMed this year to date—marking an overall staff increase of nearly 30%.  This past July, the company also hired Dr. Jun T. Park as Vice President. Dr. Park came to ViroMed directly from eleven years as a reviewer at the US FDA overseeing new drug development and approval, who now oversees licensing & regulatory affairs at ViroMed. CSO Kim explained that “all hires this year are coming in as department heads or higher,” and that the company is “focusing particularly on strengthening expertise in quality management, clinical management, and process development.” Establishing new facilities for new drug production has been underway as well. Late last month, Reyon Pharmaceutical, which holds the manufacturing rights to VM202 substance, began construction of a new factory in Chungju, Korea, which will produce VM202 drug substance.

The company is also working to expand the therapeutic range of VM202 targeting PDPN. This past July, the US FDA approved ViroMed’s another phase III trial of VM202 targeting painful diabetic peripheral neuropathy (PDPN).

Nearly 60 to 70 percent of PDPN patients are not benefiting from existing medications, and as such, if VM202’s efficacy is confirmed, the size of its addressable market is expected to be worth close to KRW 10 trillion. The company is anticipating to submit a BLA around 2021 once the PDPN trials are complete. CSO Kim noted that “ViroMed has been discussing licensing out opportunities with multiple global pharmaceutical companies.”


ViroMed is Korea’s first venture company situated within a university. CSO Kim originally founded ViroMed in 1996 with two fellow researchers. The company then became the first in the country to undertake gene therapy clinical trials, the first in the world to reach phase III trials for diabetic peripheral neuropathy and foot ulcers, among others—making ViroMed one of the top forces in the field of gene therapy treatment worldwide. Of the three DNA-based gene therapy treatments currently in phase III in the US, two belong to ViroMed.


ViroMed is also developing treatment for neurological and vascular diseases using gene therapy. “By 2025, our new drug candidates currently under development will be in globally conducted phase III trials,” said CSO Kim.

 


Translated by English Editor


Original text in Korean: 김선영 바이로메드 R&D 총괄 사장 "유전자치료제 연구 '순항' 생산 준비단계 들어갔다" | IT/과학 | 바이오 | 한경닷컴