BTG licensed Japanese rights covering glucarpidase to Ohara Pharmaceutical of Japan. Glucarpidase is an experimental treatment for the rapid and sustained reduction of toxic methotrexate (MTX) levels due to impaired renal function. Under terms of the agreement BTG will also supply glucarpidase to Ohara.
Ohara will be responsible for the development program and registration in Japan. Ohara plans to work with oncologists to execute clinical trials that will be funded by a grant from the Ministry of Health, Labour and Welfare.
An IND application for glucarpidase in Japan was submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) on December 5. “Ohara Pharmaceuticals is an ideal partner for glucarpidase as they are developing an orphan drug business in Japan and have access to specialist knowledge for oncology products,” according to Richard Mason, M.D., BTG’s head of business development.
High dose MTX chemotherapy is used to treat or prevent the recurrence of certain types of cancer in both adults and children, such as leukemia, lymphoma, and osteosarcoma. Patients may be considered at risk of MTX toxicity if they have developed impaired renal function, which can lead to a delay in elimination of MTX from the body.
Glucarpidase is not yet approved in any country. It is currently available in the U.S. under an expanded access IND and cost recovery program and in select countries outside the U.S. on a named patient basis. The FDA accepted a BLA for glucarpidase in September, and a priority review was granted. The FDA’s goal for completing the BLA review is January 17, 2012. In Europe BTG received feedback from EMA and is investigating the availability of a suitable nonclinical model to generate data to support resubmission of its MAA.