BMS and Ono to collaborate on immunotherapy combinations in Japan

Plans for the first global launch of Opdivo, the first in a new class of immunotherapy which promise a major advance in cancer treatment, are moving ahead in Japan.

Japanese pharma company Ono received marketing approval for Opdivo (nivolumab) on 4 July in its home market as a treatment for unresectable melanoma. Ono has held the marketing rights to the drug since 2005 when it signed a deal with Medarex, which was acquired by Bristol Myers Squibb in 2009.

Ono and BMS have now agreed to co-market the drug in Japan, South Korea and Taiwan, which should help the new therapy gain faster uptake in its first markets.

In addition to that, the companies have also agreed to jointly develop and market the drug in multiple immunotherapy combinations for these markets, to help target the best treatment for a broad range of cancers.

Opdivo is a PD-1 immune checkpoint inhibitor approved in Japan for the treatment of patients with unresectable melanoma, making it the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world, and is being developed in multiple tumour types in more than 35 clinical trials.

Bristol-Myers Squibb and Ono will jointly develop and commercialise Opdivo (nivolumab) and BMS’s existing immunotherapy Yervoy (ipilimumab) across a broad range of tumour types.

The agreement also includes three additional early-stage clinical immuno-oncology assets from BMS: lirilumab, an antibody that blocks the KIR receptor on natural killer cells, urelumab, an agonist of the CD137 co-stimulatory receptor, and BMS-986016, a LAG3 immune checkpoint inhibitor.

BMS, which has marketing rights to Opdivo for the rest of the world, plans to file it with the FDA in the third quarter, with a European filing expected shortly afterwards.

A number of other contenders in the immunotherapy field are hot on the heels of BMS, including Merck, Roche and AstraZeneca.

Market analysts Decision Resources forecast that the immunotherapy market will grow from just over $1 billion in 2012 to nearly $9 billion in 2022 in the US, France, Germany, Italy, Spain, UK and Japan.

This growth will be driven by the anticipated launch of nine novel immunotherapies – including four novel immune checkpoint inhibitors and five novel therapeutic vaccines in a range of new oncology indications and patient groups.

BMS’s Yervoy and novel immune checkpoint inhibitors that target the anti-programmed cell death-1/programmed death-ligand-1 (PD-1/PD-L1) pathway – including BMS/Ono’s Opdivo Merck’s pembrolizumab (MK-3475), Roche’s MPDL-3280A and AstraZeneca’s MEDI4736 are expected to dominate the market.


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