Genentech, Inc. (NYSE:DNA), GlycArt, a company wholly-owned by Roche, and Roche (SWX:ROG) have entered into a collaboration agreement, including a license from GlycArt to Genentech, for the joint development and commercialization of GlycArt’s GA101 molecule. The companies will be developing GA101, a humanized anti-CD20 monoclonal antibody engineered to increase both direct- and immune-mediated target cell death, for the potential treatment of hematological malignancies and other oncology-related B-cell disorders such as non-Hodgkin’s lymphoma.
Pablo Umaña, Chief Scientific Officer and co-founder of GlycArt, said, "With its unique mode of action, we believe GA101 has the potential to extend the therapeutic benefit over current standards of care, including treatment for patients who do not respond to current therapies.”
"This collaboration with GlycArt and Roche for the GA101 molecule complements our existing research program and our focus on innovative compounds,” said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. "We are pleased that through this program we may have the potential to offer a new option to treat patients with hematological malignancies.”
"Our early investment in pioneering technologies continues to provide new hope for patients,” said William M. Burns, CEO Roche Pharmaceuticals. "The exciting work in antibody engineering carried out by our scientists at GlycArt can now be taken to the next stage in developing clinically differentiated treatments.”
In association with this agreement, Genentech, Roche and GlycArt will share certain development costs and Genentech will record $105 million in research and development expense in its third quarter 2008 results. Genentech will receive commercialization rights in the United States.
GA101 is currently in Phase I/II clinical trials for CD20-positive B-cell malignancies, such as non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). GlycArt and Roche plan to provide an update on Phase I data for GA101 at the American Society of Hematology meeting in December 2008.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with significant unmet medical needs. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.
GlycArt, a Swiss biotechnology company owned by Roche, is focused on antibody engineering to generate new, more efficacious drug candidates that are jointly developed with Roche. GlycArt is located in Schlieren, was founded in 2000 as a spin-off of the Swiss Federal Institute of Technology (ETH)-Zurich, and was acquired by Roche in 2005.
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totaled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at http://www.roche.com.
This press release contains forward-looking statements regarding the potential of the GA101 molecule. Such statements are predictions and involve risks and uncertainties such that actual results may differ materially. Actual results may be affected by a number of factors including, but not limited to, unexpected safety, efficacy or manufacturing issues, difficulty enrolling patients in clinical trials, the need for additional data or clinical studies, FDA actions or delays, failure to obtain or maintain FDA approval, competition, pricing, reimbursement, the ability to supply product, product withdrawals, new product approvals and launches, and intellectual property or contract rights. Please also refer to the risk factors described in Genentech's periodic reports filed with the Securities and Exchange Commission. Genentech disclaims, and does not undertake, any obligation to update or revise any forward-looking statements in this press release.