Avastin is currently approved in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer. This approval was based on results of the Phase III E2100 study and granted under the FDA's accelerated approval program, which allows provisional approval of medicines for cancer or other life-threatening diseases. Currently, the effectiveness of Avastin in metastatic breast cancer is based on an improvement in PFS.

Avastin is not indicated for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease, said Genentech.

Hal Barron, executive vice president of global development and chief medical officer of Genentech, said: "We look forward to working with the FDA to evaluate the data from more than 2,600 women with advanced breast cancer who participated in these studies that showed Avastin in combination with various chemotherapies helped them live longer without the disease worsening."

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The other application is based on the Phase III RIBBON-1 trial, which evaluated Avastin in combination with Xeloda (capecitabine; Roche), or taxane- or anthracycline-based chemotherapy. The two groups demonstrated improvements in PFS of 45% and 55%, respectively, with the addition of Avastin.

Avastin is an IgG1 monoclonal antibody specifically directed to the vascular endothelial growth factor (VEGF). The VEGF protein is an essential component of the angiogenesis pathway critical for blood vessel formation facilitating tumor growth, invasion and metastasis. Avastin is already approved for the treatment of metastatic HER-2-negative breast cancer in combination with paclitaxel. Indeed, it is a multi-blockbuster drug for Genentech and Roche, with sales of $4.8 billion in 2008.

Breast cancer is the most common cancer in women worldwide, with incidence in the seven major markets forecast to be over 455,000 in 2009. HER-2-positive patients account for 20-25% of the total population and have a poorer prognosis owing to more aggressive tumors, greater lymph node involvement, and a higher rate of recurrence and mortality than those with HER-2-negative tumors.

The FDA had previously granted accelerated approval to Avastin in combination with paclitaxel in this indication, based on a 5.9 month PFS extension shown in the Phase III E2100 trial. Under the FDA's accelerated approval program, drugs can be made available on the market on the basis of preliminary evidence of patient benefit. While Avastin has not been shown to improve overall survival, it has demonstrated an improvement in PFS and there were no unexpected side effects. As such, these latest applications for Avastin stand an excellent chance of gaining FDA approval, and may serve to boost the drug's sales and reaffirm its status as a blockbuster for Roche and Genentech.

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Reach was a global, multi-center, randomized, open-label, Phase III study sponsored by Genentech, Biogen Idec and Roche that enrolled 552 patients with previously treated (relapsed or refractory) CD20-positive CLL who had not previously received Rituxan (Rituxan-naive).

Both studies evaluated Rituxan plus fludarabine and cyclophosphamide (FC) chemotherapy compared with FC chemotherapy alone. The primary endpoint for both studies was progression-free survival and secondary endpoints were overall survival, event-free survival, duration of response, response rate, complete response and toxicity.

The FDA has not requested any new data to complete its review of these applications. Genentech and Biogen Idec will continue final label discussions with the FDA and are committed to making Rituxan in combination with FC an FDA-approved option for people with CLL.

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About Chronic Lymphocytic Leukemia

According to the American Cancer Society, CLL is the most common adult leukemia, accounting for one-third of all leukemia in the United States. Nearly 90,000 Americans are living with CLL and more than 15,000 new cases will be diagnosed this year. It is a slow-growing disease that occurs when too many abnormal white blood cells are found in the blood and bone marrow, making it difficult for the body to fight infection.

Rituxan in Chronic Lymphocytic Leukemia

These applications are based on data from two Phase III studies, CLL8 and REACH. Sponsored by Roche and conducted by the German CLL Study Group, CLL8 was a global, multi-center, randomized, open-label, Phase III study that enrolled 817 patients with previously untreated (first-line) CD20-positive CLL. REACH was a global, multi-center, randomized, open-label, Phase III study sponsored by Genentech, Biogen Idec and Roche that enrolled 552 patients with previously treated (relapsed or refractory) CD20-positive CLL who had not previously received Rituxan (Rituxan-naive). Both studies evaluated Rituxan plus FC chemotherapy compared with FC chemotherapy alone. The primary endpoint for both studies was progression-free survival and secondary endpoints were overall survival, event-free survival, duration of response, response rate, complete response and toxicity.

About Rituxan

Rituxan is a therapeutic antibody that binds to a specific protein called CD20 found on the surface of cancerous and normal B-cells. In non-Hodgkin's lymphoma (NHL) and rheumatoid arthritis (RA), Rituxan works with the body's own immune system to eliminate CD20-positive B-cells. Stem cells (B-cell progenitors, those cells that give rise to B-cells) in bone marrow do not have the CD20 protein. B-cells usually regenerate after Rituxan treatment and return to normal levels in about 12 months for most patients.

Rituxan, discovered by Biogen Idec, first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. It was approved in the European Union under the trade name MabThera(R) in June 1998. Rituxan is also approved for the treatment of NHL for the following:

-- Previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP chemotherapy.

-- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent, after first-line CVP chemotherapy.

-- Previously untreated diffuse large B-cell, CD20-positive, NHL in combination with CHOP (or other anthracycline-based chemotherapy regimens).

Rituxan received FDA approval for RA in February 2006 and is currently indicated in combination with methotrexate for the treatment of adult patients with moderately-to severely-active RA who have had inadequate response to one or more tumor necrosis factor antagonist therapies.

Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

Rituxan Safety

Rituxan therapy does involve risks. Life-threatening side effects related to Rituxan therapy include infusion reactions and kidney and skin problems, and progressive multifocal leukoencephalopathy (PML, a rare condition that causes nerve damage within the brain). Serious side effects have occurred in patients treated with Rituxan including hepatitis B virus infections with related serious liver problems, other viral infections, heart problems, kidney failure, and stomach and bowel problems.

The most common adverse reactions observed in Rituxan-treated patients include fever, headache, chills and shakes, nausea, itching, hives, cough, sneezing, and throat irritation or tightness. These usually occur within 24 hours after the first infusion. Other common side effects include headache, nausea, upper respiratory tract infection, and aching joints.

For additional safety information, please see the full prescribing information, including Boxed WARNINGS and Medication Guide, at 1-800-821-8590 or visit http://www.gene.com.

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 serious or life-threatening medical conditions. The company, a wholly-owned member of the Roche Group, has headquarters in South San Francisco, Calif. For additional information about the company, please visit http://www.gene.com.

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 http://www.biogenidec.com.

SOURCE: Genentech, Inc.

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