Busulfex (busulfan) : Kyowa Hakko Kirin returns rights to Busulfex to Otsuka

Article | 17 September 2012Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) has reached agreement on returning development and marketing rights for cancer drug Busulfex (busulfan) to Otsuka Pharmaceuticals (TYO: 4578), for use as a part of conditioning regimen prior to hematopoietic progenitor cell transplantation. As a result, Kyowa Hakko Kirin will receive 2 billion yen ($25.3 million).Otsuka acquired rights to the drug from USA-based PDL Pharma for $200 million (The Pharma Letter December 24, 2007). Busulfex is currently developed and marketed by Kyowa Hakko Kirin in Japan and in six Asian countries and regions (China, Korea, Taiwan, Singapore, Malaysia and Thailand). Kyowa Hakko Kirin had in-licensed the development rights and dealership within Japan and in Asian countries and regions. The contract will terminate as of March 31, 2013, and Kyowa Hakko Kirin will return the rights to Otsuka Pharmaceutical on April 1, 2013.Busulfex is currently sold in 57 countries and regions, and has now become established as the standard drug as a conditioning agent administered prior to bone marrow transplants, an important treatment together with radiotherapy. Busulfex will be developed and marketed in nine countries and regions including the USA and Canada, once its development and marketing rights within Japan and in Asian countries and regions are returned to Otsuka Pharmaceutical.Busulfex is marketed by Otsuka Pharmaceutical's local affiliate in the USA and in Canada, and Kyowa Hakko Kirin and its local affiliates market in Asian countries and regions including Japan. France's Laboratoire Pierre Fabre markets Busulfex in Europe, Latin America and Africa. Kyowa Hakko Kirin to Otsuka say they will take all possible measures to ensure the fluent transfer of business operations, including product distribution and product communications.

BUSULFEX® (busulfan) Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.