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.
About Genentech
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.
About GlycArt
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.
About Roche
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.