Ono Pharmaceutical and Bristol-Myers Squibb (BMS) amended their existing agreement for development and commercialization of the clinical-stage anti-PD-1 antibody BMS-936558/ONO-4538, and in addition the firms inked a new deal for co-development and co-commercialization of BMS’ rheumatoid arthritis drug Orencia (abatacept) in Japan.
The expanded BMS-936558/ONO-4538 agreement gives BMS rights to develop the antibody globally except in Japan, Korea, and Taiwan, territories that Ono has retained. BMS had originally acquired North American rights to BMS-936558/ONO-4538 through its takeover of Medarex in 2009; Ono and Medarex signed their research collaboration for development of BMS-936558/ONO-4538 back in 2005.
BMS-936558/ONO-4538 is currently undergoing Phase I and II development in the U.S. against tumor types including renal cell carcinoma and melanoma. Ono is currently preparing to start a Phase II melanoma study in Japan.
The new co-development deal for Orencia in Japan applies to both the currently approved intravenous formulation of the drug, the subcutaneous formulation, and all future indications, BMS notes. Orencia IV was launched in Japan in September 2010, and is indicated for use in patients for whom all other treatments have failed. The subcutaneous formulation of Orencia is currently undergoing Phase III development in Japan. Under the firms’ agreement, BMS’ Japanese subsidiary will distribute and book sales of Orencia IV, and Ono will distribute and book sales of Orencia SC. The firms will jointly promote both formulations: Ono’s participation in this activity will start when the postmarketing surveillance period for Orencia IV has concluded, which is estimated to be in 2013.
BMS reported global Orencia sales of $427 million in the first six months of 2011, up from $347 in the equivalent period during 2010.