ViroMed's Plasmid DNA Facility Buy Addresses Key Potential US Regulatory Hurdle

ViroMed, which is progressing Phase III clinical trials for its gene therapy VM202 in the US, has acquired a plasmid DNA manufacturing facility in San Diego, a move that will enable the South Korean biotech to provide stable supplies of the product if approved, and addressing a major uncertainty for gene therapies seeking regulatory approval from the FDA.

ViroMed Co. Ltd. has acquired a specialized production facility in San Diego, California for the manufacture of plasmid DNA for its non-viral gene therapy VM202 (donaperminogene seltoplasmid), which is undergoing late phase clinical trials in the US with a view to filing and approval in this market.

The acquisition will enable the South Korean biotech company to have a stable supply of plasmid DNA, thereby removing a...

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