Monday, Oct 27, 2008
South San Francisco, Calif. and Cambridge, Mass. -- October 27, 2008 --Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) announced that Rituxan&®: (rituximab) data including results from Phase II and III studies of Rituxan in patients with moderately-to-severely active rheumatoid arthritis (RA) will be featured in two podium presentations and eight poster presentations at the American College of Rheumatology (ACR) Annual Scientific Meeting in San Francisco this week.
Among the studies being presented are a Phase III controlled re-treatment trial with Rituxan in patients who have had an inadequate response to previous treatment with one or more tumor necrosis factor (TNF) antagonist therapies; data from the first Phase III study of Rituxan plus methotrexate in biologic-naïve RA patients; and Phase II data evaluating immune response to vaccines in Rituxan-treated patients.
Data from SUNRISE, the first randomized, double-blind, placebo-controlled Phase III study assessing fixed interval retreatment of Rituxan in moderately-to-severely active RA patients who had an inadequate response to previous treatment with at least one TNF inhibitor, will be presented in a podium presentation.
At 48 weeks, a significantly greater proportion of patients who received two courses of Rituxan (two infusions of 1000 mg at each course) maintained at least a 20 percent improvement in signs and symptoms of RA, as measured by ACR20, compared to those who received one course of Rituxan followed by one course of placebo. Of the 318 patients retreated with a second course of Rituxan, 53.5 percent achieved an ACR20 response compared to 44.6 percent of the 157 patients who received one course of Rituxan and were retreated with placebo (p=0.0195). Patients who achieved clinical response to a first course of Rituxan and received retreatment with placebo were more likely to lose response, compared to patients who received retreatment with Rituxan.
The incidence of adverse events, serious adverse events or infections among patients receiving one or two courses of Rituxan was similar.
"SUNRISE is an important study because it provides greater clarity on the use of subsequent courses of Rituxan among RA patients who have previously been treated with anti-TNFs," said Philip Mease, M.D., Director of Rheumatology Research, Swedish Medical Center and Clinical Professor of Medicine, University of Washington, Seattle. "These results show that patients who received fixed interval retreatment with Rituxan maintained treatment response, with a safety profile consistent with that previously reported for Rituxan. Retreatment tended to reduce the chance of disease recurrence that often occurs after six months. Patients who did not receive retreatment at this time were more likely to experience disease flare."
Rituxan plus Methotrexate in Biologic-Naïve RA Patients
Data from a 24-week pivotal Phase III study known as SERENE evaluating Rituxan in 509 biologic-naïve RA patients who inadequately responded to the non-biologic disease modifying anti-rheumatic drug (DMARD) methotrexate (MTX) will also be presented for the first time. As announced in January 2008, SERENE met its primary endpoint, demonstrating a statistically significant improvement in ACR20 scores among patients who received a single treatment course of two infusions of either 500 mg or 1000 mg of Rituxan in combination with a stable dose of MTX compared to patients who received placebo in combination with MTX (55.1 percent and 50.6 percent for the Rituxan treatment arms compared to 23.3 percent in the placebo arm, p 0.0001 for both comparisons).
The incidence of overall adverse events, serious adverse events, overall infections and serious infections was comparable between Rituxan and placebo treatment groups in SERENE. Although there were more infusion-related reactions with the first Rituxan infusion, these reactions were primarily mild to moderate in severity and reversible with medical intervention. There were no serious infusion reactions with Rituxan.
Immune Response in Rituxan-Treated Patients
In a separate podium presentation, a Phase II study known as SIERRA showed comparable immune response to tetanus vaccines in patients receiving Rituxan in combination with MTX compared to patients receiving placebo plus MTX (39 percent of Rituxan-treated patients with a 4-fold titer rise compared to 42 percent of patients receiving placebo). Patients who received Rituxan in combination with MTX had decreased responses to pneumococcal polysacchride vaccine, which provides protection against a bacterium that causes one of the most common and severe forms of pneumonia. However, many patients were able to mount responses (57 percent of Rituxan-treated patients with a 2-fold titer rise to greater than or equal to 1 pneumococcal serotype compared to 82 percent of patients receiving placebo).
Rituxan, in combination with MTX, is indicated to reduce signs and symptoms and to slow the progression of structural damage in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF antagonist therapies.
Genentech and Biogen Idec submitted a supplemental Biologics License Application (sBLA) on September 15, 2008 for an expanded indication for Rituxan in patients with moderately-to-severely active RA who inadequately respond to one or more non-biologic DMARDs.
About Rheumatoid Arthritis (RA)
RA is a debilitating autoimmune disease that affects an estimated 1.3 million Americans and hinders daily activities. The damage that occurs in RA is a result of the immune system attacking joint tissue, causing painful chronic inflammation and irreversible destruction of cartilage, tendons and bones, which often results in disability. Common RA symptoms include inflammation of the joints, swelling, fatigue, stiffness and pain. Additionally, since RA is a systemic disease, it can affect other tissues such as the lungs and eyes.
Rituxan, discovered by Biogen Idec, is a therapeutic antibody that first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma (NHL) as a single agent. It was also approved in the European Union under the trade name MabThera&® in June 1998.
In addition, Rituxan received FDA approval in September 2006 for previously untreated patients with follicular, CD20-positive, B-cell NHL in combination with CVP (cyclophosphamide, vincristine, and prednisolone) chemotherapy and also for the treatment of non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent, after first-line CVP chemotherapy. Rituxan is also approved for previously untreated diffuse large B-cell, CD20-positive, NHL in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or other anthracycline-based chemotherapy regimens.
In February 2006, Rituxan also received FDA approval in combination with MTX to reduce signs and symptoms in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF-antagonist therapies. Additionally, in January 2008, Rituxan received FDA approval in combination with MTX to slow the progression of structural damage in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF-antagonist therapies. Rituxan is the first treatment for RA that selectively targets immune cells known as CD20-positive B cells. Rituxan does not target the entire immune system.
CD20 is not found on stem cells, pro-B cells (B cell precursors), normal plasma cells, or other normal tissues. Rituxan does not target plasma cells. These plasma cells make antibodies that help fight infections.
Rituxan does not target stem cells in the bone marrow, and B cells can usually regenerate and gradually return to normal levels after treatment with Rituxan in about 12 months for most patients.
Over the past ten years, there have been more than one million patient exposures to Rituxan across all indications.
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 has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML).
Hepatitis B reactivation with fulminant hepatitis, other viral infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation have also been observed. Patients should be closely observed for signs of infection if biologic agents and/or disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate are used concomitantly.
The most common adverse reactions observed in Rituxan-treated RA patients are hypertension, nausea, upper respiratory tract infection, arthralgia, pruritus, and pyrexia.
The most common adverse reactions observed in Rituxan treated NHL patients (incidence greater than or equal to 25 percent) are infusion reactions, fever, chills, infection, asthenia, and lymphopenia.
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.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines for 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 Biogen Idec
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.
This press release contains forward-looking statements regarding the potential of Rituxan to treat RA patients. 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, data analysis or clinical studies, BLA preparation, FDA actions or delays, failure to maintain FDA approval, competition, pricing, reimbursement, the ability to supply product, product withdrawals and 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 statement in this press release.