Genentech is taking over full responsibility for ocrelizumab against multiple sclerosis.

Biogen Idec and Roche’s Genentech have restructured their existing collaboration for the development of CD20-targeting antibodies. The amended partnership gives Genentech full responsibility for further development and commercialization of ocrelizumab against multiple sclerosis (MS). The firm will in addition shoulder all associated costs.

Biogen Idec will receive tiered, double-digit royalties on U.S. sales of the antibody. The royalty levels will roughly equate to the company’s previous 30% interest in the candidate. The firms have also agreed that commercialization of ocrelizumab will not impact their current profit-sharing arrangement for Rituxan® (rituximab).

Changes have in addition been made to Genentech and Biogen Idec’s partnership for development and commercialization of GA101, a next-generation anti-CD20 antibody targeting chronic lymphocytic leukemia and non-Hodgkin lymphoma. The amendments mean Biogen Idec will increase its share of the losses and profits related to U.S. development and commercialization of GA101 from 30% to 35%. The firm will in addition pay Genentech about $10 million as a catch-up payment for GA101-related expenses incurred by the latter to date. On the achievement of specific GA101 sales milestones, Biogen Idec’s share of the co-promotion profits for Rituxan will drop from 40% to 35%.

Genentech says the restructured agreements will help prevent any future profit-sharing disputes arising in relation to GA101 and Rituxan. “The companies’ interests are now aligned, allowing us to work together to maximize the revenues for the collaboration products while maximizing the benefit for patients,” suggests George Scangos, Ph.D., Biogen Idec CEO. “This agreement allows Genentech and Roche to aggressively develop the compound in MS, while allowing Biogen Idec to avoid a further concentration of its R&D dollars in Phase III trials for multiple sclerosis.”

Just last week Genentech and Biogen Idec reported positive data from a Phase II placebo-controlled study of ocrelizumab in 220 patients with relapsing-remitting multiple sclerosis (RRMS). Compared with placebo therapy, the higher 2,000 mg dose of ocrelizumab led to a 96% reduction in the total number of brain lesions detected by magnetic resonance imaging (MRI) scans. The 600 mg dose of ocrelizumab led to an 89% reduction in the number of MRI-detected lesions.

Ocrelizumab therapy also resulted in a 73–80% reduction in disease activity at 24 weeks, as measured by the annualized relapse rate (ARR). “These efficacy results are amongst the most remarkable seen in a Phase II RRMS study,” comments lead trial investigator, Ludwig Kappos, M.D., from the department of neurology, University Hospital Basel in Switzerland.

The positive Phase II RMMS data are in contrast to the failed Phase III rheumatoid arthritis (RA) program for ocrelizumab. The RA program had included four Phase III trials, but in May Genentech and Biogen Idec confirmed they were discontinuing development of the antibody for this indication because the “overall benefit to risk profile of ocrelizumab was not favourable in RA taking into account the currently available treatment options.”

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