Monday, Nov 1, 2004
South San Francisco, Calif., Cambridge, Mass., San Diego, Calif. and Basel -- November 1, 2004 --Genentech, Inc. (NYSE: DNA), Biogen Idec (Nasdaq: BIIB) and Roche (SWX Zurich) announced today that a Phase IIb clinical study of Rituxan® (Rituximab) met its primary endpoint of a greater proportion of Rituxan-treated patients achieving an American College of Rheumatology (ACR) 20 response at week 24, compared to placebo, in patients who were also treated with methotrexate (MTX). In this study, patients with moderate-to-severe rheumatoid arthritis (RA) who received two infusions of Rituxan over a two-week period in combination with a stable dose of MTX experienced improved symptoms compared to patients who received placebo and MTX. The benefit in the Rituxan-treated patients was present regardless of whether additional corticosteroids were administered.
DANCER (Dose-Ranging Assessment International Clinical Evaluation of Rituximab in RA) is a Phase IIb study evaluating the efficacy and safety of varying doses of both Rituxan and corticosteroids in combination with a stable dose of MTX in patients who have failed one to five disease-modifying anti-rheumatic drugs (DMARDs) and are inadequately responding to MTX. Further analyses of the data are ongoing and will be submitted for presentation at an upcoming medical meeting.
A preliminary analysis of the data did not reveal any unexpected safety signals. All regimens were generally well tolerated. Common side effects in the Rituxan arms included headache, nausea and upper respiratory infection. The reported rate of serious adverse events was not significantly different than seen in previous studies of Rituxan in RA.
Rituxan is a therapeutic antibody that binds to the CD20 antigen on the surface of B cells (or B lymphocytes), which may play a key role in the inflammatory cascade of the disease.
"These preliminary results are encouraging, as DANCER is the second randomized trial to demonstrate Rituxan's potential as a therapy for RA," said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. "We are committed to understanding the pathophysiology of autoimmune diseases in order to provide patients and physicians with new therapies."
"We look forward to presenting these data at an upcoming medical meeting and continuing our efforts to assess the potential for Rituxan as a treatment for this debilitating condition," said Burt Adelman, M.D., executive vice president, development, Biogen Idec.
About the Study
A total of 465 patients from the United States, Canada, Europe and Australia were randomized in this multi-center, randomized, double-blind, placebo-controlled study. Nine groups of patients received a stable dosage of MTX and a varying dose of Rituxan (placebo; 2 x 500 mg; 2 x 1000 mg) and corticosteroids (placebo; i.v. 200 mg; and i.v. 200 mg + p.o. 570 mg).
ACR 20 indicates a 20 percent improvement in the number of swollen and tender joints, as well as a 20 percent improvement compared with baseline in three of five disease-activity measures: patient assessment, physician assessment, pain scale, Health Assessment Questionnaire and the value for one acute phase reactant (erythrocyte sedimentation rate or C-reactive protein).
RA is a debilitating autoimmune disease that affects more than two million Americans and hinders the daily activities of sufferers.1 RA occurs when the immune system inappropriately attacks joint tissue, causing chronic inflammation and irreversible destruction of cartilage, tendons and bones. Symptoms include inflammation of the joints, swelling, stiffness and pain. Additionally, since RA is a systemic disease, it can have effects in other tissues such as the lungs, eyes and bone marrow.
Rituxan is a therapeutic antibody that selectively targets B cells. Rituxan received initial 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). It also was approved in the European Union (EU) under the trade name MabThera® in June 1998. 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 with Zenyaku Kogyo Co. Ltd. Rituxan has been used to treat more than 380,000 patients worldwide. For a copy of the Rituxan full prescribing information, including Boxed Warning, please call 1-800-821-8590 or visit http://www.gene.com.
Rituxan Safety Profile in NHL
In NHL patients, the majority of patients experience infusion-related symptoms with their first Rituxan infusion. These symptoms include but are not limited to: flu-like fever, chills/rigors, nausea, urticaria, headache, bronchospasm, angioedema and hypotension. These symptoms vary in severity and generally are reversible with medical intervention. In rare instances, severe and fatal infusion-related reactions have occurred, nearly all of which have been associated with the first Rituxan infusion. These events appear as manifestations of an infusion-related complex and include hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock and tumor lysis syndrome. Patients who develop clinically significant infusion-related cardiopulmonary events should have their Rituxan infusion discontinued and receive medical treatment.
In rare instances, severe mucocutaneous skin reactions have occurred that may be associated with Rituxan therapy. Many of these reactions have been described as paraneoplastic pemphigus and are known to be associated with various B-cell lymphomas, particularly NHL and chronic lymphocytic leukemia. Patients who develop a severe mucocutaneous skin reaction should have Rituxan discontinued and receive appropriate medical treatment, including a skin biopsy to guide therapy.
About Genentech Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products directly in the United States and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is traded 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 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 www.biogenidec.com.
Headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market and is the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche employs roughly 62,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Please visit www.roche.com for further information.
1American College of Rheumatology, 2004