SINGAPORE--AnGes MG has formed a new partnership with Mitsubishi Tanabe Pharma Corporation for the marketing of investigational gene therapy Collategene (beperminogene perplasmid) in Japan, ending ties with Daiichi Sankyo, according to a Feb. 17 email statement.
The biotech reached a basic agreement with Mitsubishi Tanabe and will give the new partner exclusive marketing rights to Collategene pending a final deal accord for the treatment of peripheral arterial diseases. In 2012, AnGes MG had granted Mitsubishi Tanabe exclusive marketing rights in the U.S. for the same diseases.
In Japan, Collategene was filed for approval in 2008 for the treatment of critical limb ischemia (CLI), but the application was withdrawn in 2010. An investigator-initiated study is ongoing in Japan for patients with CLI, while a multinational Phase III clinical trial is also underway in the U.S. and Europe.
Once the studies are done, AnGes MG plans to seek conditional and time-limited approval in Japan under the Pharmaceuticals and Medical Devices Law for regenerative medicine products, which includes gene therapies, as early as the end of 2015.