Biogen Idec Inc. said it will pay a $31.5 million up-front fee to join Genentech Inc. and F. Hoffmann-La Roche Ltd. in the development of a humanized anti-CD20 monoclonal antibody, GA101.
The three companies already collaborate on the anti-CD20 monoclonal antibody Rituxan (rituximab), which is approved for non-Hodgkin's lymphoma (NHL) and rheumatoid arthritis. Last month, the drug also met its endpoints in its second Phase III trial for chronic lymphocytic leukemia (CLL). (See BioWorld Today, Oct. 8, 2008.)
Yet while Rituxan is a chimeric antibody, GA101 is humanized, which may result in less immunogenicity.
Other biotechs seeking to improve on Rituxan include Immunomedics Inc. and Nycomed GmbH, which are partnered on the humanized anti-CD20 antibody, veltuzumab. While Rituxan is administered intravenously, veltuzumab is administered subcutaneously, which could result in added convenience and a lower dosage. The antibody is in Phase I/II trials for idiopathic thrombocytopenic purpura and NHL. (See BioWorld Today, July 16, 2008.)
Another potential competitor is ofatumumab (HuMax-CD20), a fully human anti-CD20 monoclonal antibody from Genmab A/S and GlaxoSmithKline plc. The drug is in Phase III trials for CLL, NHL and rheumatoid arthritis.
Also targeting CD20 are Trubion Pharmaceuticals Inc. and Wyeth, which are partnered on TRU-015 for rheumatoid arthritis and SBI-087 for rheumatoid arthritis and systemic lupus erythematosus. Both molecules are antibody-esque peptides called small modular immunopharmaceuticals.
And in preclinical studies is InNexus Biotechnology Inc.'s DXL625, a humanized antibody designed to have improved binding to CD20.
Biogen Idec and Genentech aren't ignoring the potential competition. The two companies are developing their own suite of second-generation anti-CD20 monoclonal antibodies. The lead candidate, a humanized antibody called ocrelizumab, is in Phase III for rheumatoid arthritis.
Naomi Aoki, director of public affairs at Biogen Idec, said that while ocrelizumab seems to be stronger as a treatment for autoimmune diseases, new addition GA101 appears to have more potential in blood cancers. The antibody is in Phase I/II trials for CD20-positive B-cell malignancies, such as NHL and CLL.
GA101 was developed by GlycArt AG, which was acquired by Roche for about $180 million in 2005.
In early October, Genentech paid Roche $105 million and agreed to share certain development costs associated with GA101 in exchange for U.S. commercialization rights to the antibody.
Biogen Idec then paid Genentech $31.5 million and agreed to share certain development costs in exchange for an undisclosed share in the U.S. profits and losses for GA101.
The relationship between Biogen Idec, Genentech and Roche dates back more than a decade. IDEC Pharmaceuticals Inc., which developed Rituxan prior to its 2003 merger with Biogen Inc., established a co-development and co-promote deal with Genentech for U.S. sales of the drug. IDEC also signed a deal with Roche for ex-U.S. sales.
Biogen Idec's partnership with Genentech also covers co-development of second-generation anti-CD20 antibodies. The agreement specifies that if Genentech in-licenses an anti-CD20 antibody, such as it did with GA101, Biogen Idec has a 30-day option to elect to participate in the drug's development.
Additional financial terms were not disclosed.
Shares of Cambridge, Mass.-based Biogen Idec (NASDAQ:BIIB) rose $2.25 to close at $42.55 on Friday, while shares of South San Francisco-based Genentech (NYSE:DNA) rose 19 cents to close at $82.94.