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The long-term agreement gives CombiGene the authority to manufacture and commercialize the drug if it is approved after clinical studies.
CombiGene, a gene therapy company located in Sweden, announced it signed an agreement with Cobra Biologics, a contract development and manufacturing organization (CDMO) that provides DNA, viral vectors, and microbiota for preclinical, clinical, and commercial supply, for the production of candidate drug CG01 for epilepsy gene therapy.
The long-term agreement includes manufacturing of CG01 by Cobra for clinical studies and future commercial production, according to an Oct. 14, 2019 press release. Three seperate contracts for quality, production of plasmids, and production of CG01 are included under the Master Service Agreement. The collaboration also entitles Cobra to SEK 1.5 million (US$153,180) for the production of the candidate drug.
"I am very pleased that we have selected Cobra as our manufacturing partner” said Karin Agerman, chief research and development officer at CombiGene, in the press release. "The choice of a CDMO marks a significant milestone in the CG01 project and an important step towards clinical studies. Our collaboration will now begin in earnest and we see potential for it to continue for many years to come."
“For almost 20 years Cobra has been manufacturing DNA and viral vectors for its gene therapy customers and we are pleased to be involved in bringing CG01 closer to market,” added Peter Coleman, CEO at Cobra Biologics, in the press release. “CombiGene has recognized our expertise and track record, and this project fits perfectly into our newly expanded viral vector manufacturing facility which will soon be capable of commercial scale supply.”
Source: Cobra Biologics