CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) today announced that it has elected to participate with Genentech (NYSE: DNA) in the development and commercialization of GA101 in the United States. Genentech recently acquired development and U.S. commercialization rights to GA101 from Glycart, a company owned by Roche, and Roche. GA101 is a novel humanized anti-CD20 monoclonal antibody engineered to increase both direct- and immune-mediated target cell death for the potential treatment of hematologic malignancies. Biogen Idec elected to participate in the development of GA101 pursuant to terms outlined in the company’s existing collaboration agreement with Genentech.
“Our decision to participate in the development and commercialization of GA101 exemplifies our commitment to advancing new therapies for patients with blood cancers,” said Cecil Pickett, Ph.D., President of Research and Development at Biogen Idec.
Under the terms of the election, Biogen Idec and Genentech will share certain development costs. Biogen Idec will make an upfront payment to Genentech of $31.5 million, which will be recorded as a research-and-development expense in the fourth quarter of 2008. Biogen Idec and Genentech will share operating profits and losses in the United States. Roche retains commercialization rights outside the United States. Additional financial and other terms were not disclosed.
GA101 is currently the subject of Phase I/II clinical trials for CD20-positive B-cell malignancies such as non-Hodgkins lymphoma (NHL) and chronic lymphocytic leukemia (CLL). GlycArt and Roche plan to provide on update on Phase I data for GA101 at the American Society of Hematology Annual Meeting in December 2008.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com
Safe Harbor/Forward-Looking Statements
This press release contains forward-looking statements regarding GA101. These statements are based on Biogen Idec's current beliefs and expectations. The development and commercial potential of GA101 is subject to a number of risks and uncertainties, including the potential safety and efficacy profile of GA101 relative to other related CD20 antibodies, the projected timeline for completion of the ongoing Phase I/II study; the projected impact of GA101 on the Company's quarterly operating expenses; and other statements that are other than statements of historical facts. Drug development and commercialization involves a high degree of risk.
For more detailed information on the risks and uncertainties associated with Biogen Idec's drug development and other activities, see Item 1A "Risk Factors" in Biogen Idec's most recent Form 10-Q filing with the Securities and Exchange Commission. These forward looking statements speak only as of the date of this press release, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.