Isis Pharmaceuticals has successfully completed a preapproval inspection of its manufacturing facility in Carlsbad, CA. The EMA reviewed Isis' manufacturing facility, processes, and GMP quality systems. The approval allows Isis to supply Genzyme with Kynamro drug substance to support commercial launch in Europe.
"Isis is the leading antisense drug discovery company with a broad pipeline of more than two dozen drugs in development. As we have increased the efficiency of our drug discovery technology, we have also improved the manufacturing processes of antisense drugs. As a result, we have significantly reduced the cost of manufacturing and increased our capacity, which will support the numerous potential commercial products that could be coming out of our pipeline in the near-term," said B. Lynne Parshall, J.D., chief operating officer, chief financial officer and Secretary of Isis.