BTG announces that it has licensed the Japanese rights to glucarpidase to Ohara Pharmaceutical Co. Ltd.
Under the terms of the license agreement, BTG will also supply glucarpidase to Ohara who will be responsible for the development program and registration in Japan. Ohara plans to work in partnership with leading oncologists who will execute clinical trials in a development program for glucarpidase.
Glucarpidase is an experimental treatment for the rapid and sustained reduction of toxic methotrexate (MTX) levels due to impaired renal function. Glucarpidase is not yet approved in any country and is available in the United States under an expanded access IND and cost recovery program and in selected countries outside the United States on a named patient basis. The FDA accepted a Biologics License Application (BLA) for glucarpidase in Sept. 2011 and a Priority Review was granted.
The FDA’s goal for completing the BLA review is Jan. 17, 2012.
An IND application for glucarpidase in Japan was submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) on Dec. 5. Should glucarpidase be successfully developed and approved, Ohara will have the rights to market and sell glucarpidase in Japan.
Release Date: Dec. 7, 2011