CAMBRIDGE, Massachusetts—Biogen Idec retains joint control of development of Rituxan® (rituximab) and other anti-CD20 drugs as part of the company's collaboration agreement with Genentech, Inc, but Genentech's late-stage clinical trials of ocrelizumab for lupus and rheumatoid arthritis (RA) can continue, an artibration panel has ruled.
The arbitration panel ruled that a Joint Development Committee (JDC) comprised of three members from each company must unanimously approve a development plan for each specific indication. The panel also ruled that, absent unanimous approval of the JDC, Genentech (a unit of Roche Holding AG) may not proceed with further development of 2H7v16 in neuromyelitis optica, 2H7v16 in relapsing-remitting multiple sclerosis (RRMS), or 2H7v114 for oncology.
“We are pleased the arbitration panel upheld our reading of the contract and affirmed our joint decision-making rights,” said James C. Mullen, Biogen Idec’s President and CEO. “Our partnership with Genentech has been extraordinarily successful, and we look forward to continuing to work with them to help patients in a wide range of diseases.”
The arbitration panel rejected Genentech’s assertion that the November 2003 merger of IDEC Pharmaceuticals Corp and Biogen Inc constituted a change of control.
The decision is expected to give Biogen Idec some major bargaining chips when the two companies sit down to renegotiate their Rituxan partnership. Biogen is set to begin losing overseas royalties on Rituxan later this year under terms of the joint agreement. Biogen's share of Rituxan's US profits will also drop from 40% to 30% when a follow-on drug for Rituxan is approved.
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