americanpharmaceuticalreviewAugust 21, 2018
ViroMed announced the acquisition of a plasmid DNA production facility in San Diego, California from Vical Incorporated. With ViroMed's first Phase III clinical trial of its lead product VM202 (donaperminogene seltoplasmid) for painful diabetic peripheral neuropathy (PDPN) nearing its completion, ViroMed, in joint venture partnership with a private equity investment firm, acquired the GMP ready facility that has been until recently a production site for clinical studies including phase IIIs in the US of DNA-based investigational new drugs.
The facility in San Diego is equipped with a 500 L fermenter, cell culture lab and QC test lab, and has extra space for future expansion, making it an ideal site for both biopharmaceutical R&D and commercial-scale plasmid DNA production. With the aim to initiate first test runs within this year and GMP production in the first half of 2019, the company is securing key personnel necessary for the facility operation.
"We are very excited to secure a plasmid DNA production facility, which has been a major issue for the company. Through the acquisition, we expect to not only maximize the value of VM202 but also create additional business opportunities as we move forward," CEO Sunyoung Kim, DPhil said. "Taking a step further from an R&D-focused company, it is our vision to become a biopharmaceutical company in our own right that covers all stages of new drug development including R&D, production and quality management. ViroMed is currently the only company conducting Phase IIIs in the US involving plasmid DNA, and we are pleased to be able to demonstrate once again that ViroMed is a global leader in the field of plasmid DNA gene therapy."
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