Vical licensee files NDA in Japan

USA-based Vical says that its licensee, AnGes MG, reported submission on March 27of a New Drug Application to the Japanese Ministry of Health, Labor and Welfare for its angiogenesis product candidate, Collategene, for treatment of critical limb ischemia. The treatment uses Vical technology to deliver a gene-encoding hepatocyte growth factor, a human protein that causes growth of blood vessels in areas of restricted blood flow.

"The Japanese NDA filing positions Collategene to be the first product based on our DNA delivery technology with the potential to be approved for human use," said Vijay Samant, chief executive of Vical. In the United States, where it is estimated that more than 10 million people have peripheral arterial disease (PAD), AnGes already has completed two Phase II clinical trials of Collategene in PAD patients. This product candidate offers a novel approach to addressing an important, unserved medical need in the Japanese market, and has the potential to expand into the much larger markets worldwide. This NDA filing by AnGes is an important milestone in advancing non-viral gene therapy toward regulatory and commercial acceptance," he added.