Korean biotech ViroMed has seen companies miss out on approvals for novel therapies because the FDA had problems with their manufacturing processes. With its first treatment nearing the completion of phase 3 trials, it says it has taken steps to avoid that trap. The Seoul-based biotech this week said that in a joint venture partnership with a private equity investment firm, it had acquired a GMP ready facility in San Diego, California, from Vical Inc. Terms of the deal were not disclosed.
Until recently, the production site was used for clinical studies that included phase 3 trials in the U.S. of DNA-based investigational drugs, ViroMed said. The Korean company’s lead product VM202 (donaperminogene seltoplasmid) is a gene therapy for the treatment of painful diabetic peripheral neuropathy (PDPN).