New partner will carry out clinical trials required to achieve Japanese clearance.
Ohara Pharmaceutical negotiated Japanese development and commercialization rights to specialty pharmaceuticals company EUSA Pharma’s marketed acute lymphoblastic leukemia (ALL) therapy Erwinase®. The product is an L-asparaginase derived from Erwinia chrysanthemi, which is used to treat ALL in combination with other anticancer therapies. Under terms of the deal Ohara will be responsible for any late-stage trials required to obtain Japanese regulatory approval.
EUSA is focused on the development of products for oncology, pain control, and critical care. The firm says the deal with Ohara marks its first product partnership in Japan. “This agreement represents an important strategic milestone for EUSA,” comments Bryan Morton, EUSA president and CEO. “In the past four years EUSA has made great progress building a broad portfolio of marketed products and a specialty commercial infrastructure in Europe and North America.”
Erwinase is already approved in Canada and a number of countries in Europe, the Middle East, and Asia. Product registration is in progress in a number of other territories. Erwinase is still undergoing clinical development in the U.S. and is only available as an IND on a named patient basis, EUSA states.
