Chugai Pharmaceutical, has announced that under the terms of the license agreement signed with F. Hoffmann-La Roche on the humanized anti-human IL-6 receptor monoclonal antibody Actemra, it has decided not to exercise the opt-in right for co-promotion in the United States, Italy and Spain, and will co-promote the product with Roche in France, Germany and the United Kingdom.
In July 2003, Chugai and Roche signed a co-development and co-promotion license agreement granting Roche exclusive rights for Actemra-related patents and trademark usage for the global market excluding Japan, South Korea and Taiwan. Under the agreement, Chugai holds the right for co-promotion in France, Germany and the United Kingdom, and the opt-in right for co-promotion in the United States, Italy and Spain.
In France, Germany and the United Kingdom, where Chugai has its own marketing base, the two companies have started joint efforts to build the necessary organization and to plan marketing and promotion strategies. In the United States, Italy and Spain, however, Chugai decided not to exercise the opt-in right in those territories, in pursuit of maximizing the business value of Actemra as early as possible, and in consideration of Chugai's mid-term strategy on overseas activities. Profits will be shared in France, Germany and the United Kingdom in proportion to each company's co-promotion effort.
Chugai and Roche have been advancing the co-development of Actemra® globally, and currently phase III clinical trial programs in rheumatoid arthritis are going on in 41 countries worldwide. Four out of five phase III clinical trials are scheduled to be reported by the end of the year, and Roche is planning to file for approval in Europe and in the United States in the latter part of 2007.
Chugai and Roche aims to maximize the value of Actemra through collaboration efforts in both development and marketing activities.