WESTON, Mass. & SOUTH SAN FRANCISCO—Deciding, it seems, that it's time to wrangle out the details now at the table than fight across a table (or in a courtroom) later, Biogen Idec and Genentech Inc. a wholly owned member of the Roche Group, recently announced that they have agreed to amend their collaboration on antibodies targeting CD20.
CD20 is the target of such monoclonal antibodies as rituximab, ibritumomab tiuxetan, and tositumomab. In addition, ocrelizumab—which was discontinued for rheumatoid arthritis in 2010—is possibly indicated in multiple sclerosis.
Genentech has indicated that the restructured agreements will help prevent any future profit-sharing disputes arising in relation to GA101, a next-generation anti-CD20 antibody targeting chronic lymphocytic leukemia and non-Hodgkin lymphoma, and Rituxan (rituximab), which is aimed at various lymphomas and leukemias, as well as transplant rejection and some autoimmune disorders.
"Our partnership with Genentech and Roche is very important to us, and I believe this agreement is in the interests of both companies and patients," says Dr. George Scangos, Biogen Idec's CEO. "We recently reported positive Phase II data for ocrelizumab in multiple sclerosis, which suggest that the compound could provide a substantial benefit to patients with MS. 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. Further, we have agreed on the profit sharing arrangements for GA101 and Rituxan, which were a potential area of dispute.
Specifically, the companies have agreed that Genentech will have responsibility for the further development of ocrelizumab in multiple sclerosis. Genentech will fund 100 percent of the costs going forward and will be responsible for development and commercialization. Biogen Idec will receive tiered, double-digit royalties on U.S. sales of ocrelizumab that will approximate its current 30 percent interest in the compound. Furthermore, the companies have agreed that the commercialization of ocrelizumab will not impact the current profit share of Rituxan.
In addition, Biogen Idec and Genentech have agreed that Biogen Idec will increase its share of the losses and profits related to the development and commercialization of GA101 in the United States to 35 percent from the previous level of 30 percent.
Biogen Idec will pay Genentech approximately $10 million as a catch-up payment for expenses incurred to date on GA101 since Biogen Idec was previously paying 30 percent of the development costs. Once GA101 achieves certain sales milestones, Biogen Idec's share of the co-promotion profits of Rituxan will decrease from 40 percent to 35 percent.
"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," Scangos says.
"We believe both Genentech and Biogen Idec will benefit from the new structure of the anti-CD20 collaboration," says Dan Zabrowski, head of Roche Partnering. "Recently we announced exciting Phase II study results which showed that ocrelizumab significantly reduced disease activity as measured by brain lesions and relapse rate for patients with MS. We believe in the potential of ocrelizumab and look forward to exploring it further in Phase III studies."
Specifically, the Phase II placebo-controlled study of ocrelizumab in 220 patients with relapsing-remitting multiple sclerosis (RRMS) indicated that compared with placebo therapy, a 2,000 milligram dose of ocrelizumab led to a 96 percent reduction in the total number of brain lesions detected by magnetic resonance imaging scans—while a 600 milligram dose of ocrelizumab led to an 89 percent reduction.
Ocrelizumab therapy also resulted in a 73 percent to 80 percent reduction in disease activity at 24 weeks, as measured by the annualized relapse rate.
The positive Phase II RMMS data have been welcome news to the companies after the failure or the drug in a Phase III rheumatoid arthritis trial. In May Genentech and Biogen Idec confirmed they were discontinuing development of the antibody for the rheumatoid arthritis indication because the "overall benefit to risk profile of ocrelizumab was not favorable in RA taking into account the currently available treatment options."
