Biogen Idec And Genentech Announce Fda Acceptance Of Supplemental Biologics License Application And Priority Review Designation For Rituxan® In Rheumatoid Arthritis
CAMBRIDGE, Mass. and SOUTH SAN FRANCISCO, Calif. - October 31, 2005 - Biogen Idec, Inc. (Nasdaq: BIIB) and Genentech, Inc. (NYSE: DNA) announced today that the supplemental Biologics License Application (sBLA) submitted by the companies for Rituxan® (Rituximab) for patients with active rheumatoid arthritis (RA) who inadequately respond to anti-TNF therapy has been accepted by the U.S. Food and Drug Administration (FDA). As a part of the sBLA submission, the companies requested and have been granted Priority Review designation.
The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing approved therapies in the treatment, diagnosis or prevention of a disease. Based on the designation of Priority Review, the FDA has up to six months from the submission date, or by late February 2006, to take action on the Rituxan sBLA submission. The companies submitted the sBLA on August 29, 2005.
The sBLA submission was based primarily on 24-week results of a multi-center, randomized, double-blind, placebo-controlled Phase III study known as REFLEX. In the trial, patients who received a single course of two infusions of Rituxan with a stable dose of methotrexate (MTX) displayed a statistically significant improvement in symptoms, as measured by American College of Rheumatology (ACR) 20 response, compared to those who received placebo and MTX. The results of the REFLEX trial will be presented at the ACR annual meeting in San Diego in November 2005.
The most common side effects in the Rituxan arm of REFLEX included headache, upper respiratory tract infection and nasopharyngitis. The rate of serious adverse events reported was comparable across treatment arms. Analysis of the REFLEX 24-week data did not reveal any unexpected safety signals, and the companies continue to monitor the long-term safety of Rituxan in all clinical trials.
RA is a debilitating autoimmune disease that affects more than two million Americans1 and hinders the daily activities of sufferers. RA occurs when the immune system inappropriately attacks joint tissue, causing painful chronic inflammation and irreversible destruction of cartilage, tendons and bones, often resulting in disability. While RA has traditionally been considered a T-cell-mediated disease, emerging research suggests that other immune cells called B-cells may play multiple roles in the pathophysiology of RA, including autoantibody production, T-cell activation and cytokine production. Common RA symptoms include inflammation of the joints, swelling, fatigue, 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 targets and selectively depletes CD20-positive B-cells without targeting stem cells or existing plasma cells. Rituxan is also being studied in other autoimmune diseases, including lupus, multiple sclerosis and ANCA-associated vasculitis.
Rituxan, discovered by Biogen Idec, 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). It was approved in the European Union 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 by Chugai and Zenyaku Kogyo Co. Ltd. Rituxan has been used to treat more than 730,000 patients worldwide. For a copy of the Rituxan full prescribing information, including Boxed Warning, please call 1-800-821-8590 or visit www.gene.com.
Rituxan Safety Profile in non-Hodgkin’s Lymphoma
In NHL, 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.
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 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 www.biogenidec.com.
1American College of Rheumatology, 2005, www.rheumatology.org/public/factsheets/ra.asp?aud=pat
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