Investor Update

Basel, 06 December 2010

New Phase II data from investigational compound GA101 presented today at the American Society of Hematology

GA101, the first type II, glycoengineered anti-CD20 monoclonal antibody, demonstrates promising efficacy in difficult-to-treat patients with non-Hodgkin’s lymphoma

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new Phase II efficacy data from the investigational compound GA101 (RG 1759) in relapsed/refractory Non-Hodgkin’s Lymphoma (NHL), a common type of blood cancer. GA101 is the first type II, glycoengineered anti-CD20 monoclonal antibody that has been specifically designed to enhance the destruction of cancerous B-cells either by activating other immune cells to attack the cancer cells or by inducing direct cell death.

The results showed promising response rates in very difficult-to-treat patients with either indolent or aggressive NHL who had failed multiple prior treatments, including prior treatment with Rituxan/MabThera (rituximab). The data were presented at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida.

The efficacy data presented came from two Phase II dose-finding studies of GA101 in relapsed or refractory patients with either indolent or aggressive NHL.

In the first Phase II study in aggressive NHL (Abstract #2878), patients had received a median of 3 prior therapies and 63% had not responded to or had disease progression within 6 months of Rituxan/MabThera. Nearly a third of patients responded to treatment with GA101 (11 of 40 patients, 24% in the 400 mg cohort, 32% in the 1600/800 mg cohort). For patients no longer responding to Rituxan/MabThera, response rate was 25% in the 1600/800 mg cohort.

In the second Phase II study in relapsed/refractory indolent NHL (Abstract #2868), patients had received a median of 3 prior treatment and 55% had not responded to or had disease progression within 6 months of Rituxan/MabThera. In the overall indolent NHL population, which was heavily pre-treated, 55% of patients responded to treatment with GA101 with a promising median progression-free survival (PFS) of 11.3 months in the 1600/800 mg cohort (in the 400 mg cohort, there was a 17% response rate with 6 months of median PFS). For patients no longer responding to Rituxan/MabThera, response rate in the 1600/800 mg cohort was 50%.

“We are pleased to share these new Phase II data on GA101 at the ASH meeting” said Hal Barron, M.D., Head of Global Development and Chief Medical Officer at Roche. “The performance of GA101 in this difficult-to-treat group of patients with NHL is encouraging, and we look forward to sharing more data from the extensive GA101 clinical development program in future.”

Key GA101 abstracts presented at ASH include:

  • Promising efficacy with the new anti-CD20 antibody GA101 in heavily pre-treated NHL patients – First results from a Phase II study in patients with relapsed/refractory DLBCL and MCL. (Abstract #2878) – Sunday, December 5, 2010, 6:00 p.m. – 8:00 p.m. EST, Room Hall A3/A4.
  • Promising efficacy with the new anti-CD20 antibody GA101 in heavily pre-treated NHL patients – Updated results with encouraging PFS data from a Phase II study in patients with relapsed/refractory indolent NHL (iNHL) (Abstract #2868) – Sunday, December 5, 2010, 6:00 p.m. – 8:00 p.m. EST, Room Hall A3/A4.

About GA101

GA101 is an investigational, type II, glycoengineered anti-CD20 monoclonal antibody (mAB) which targets and binds to the CD20 protein found on cancerous B-cells which cause certain types of blood cancers such as non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). GA101 has been specifically designed to enhance the destruction of cancer cells either by activating other immune cells to attack the cancer cells or by inducing direct cell death. GA101 is the first type II glycoengineered anti-CD20 mAB to enter clinical trials in NHL and CLL and it’s being investigated in a number of Phase III studies, including head-to-head versus Rituxan/MabThera.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80’000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

All trademarks used or mentioned in this release are protected by law.