Tuesday, Jun 18, 2002
San Diego and South San Francisco, Calif. -- June 18, 2002 --
San Diego and South San Francisco, CALIF., and Basel, SWITZERLAND – June 18, 2002 – Roche, Genentech, Inc. (NYSE: DNA) and IDEC Pharmaceuticals Corporation (Nasdaq: IDPH) today announced positive preliminary results of a randomized, controlled and double-blind Phase II study evaluating Rituxan® (Rituximab/MabThera®) alone or in combination with other therapies in rheumatoid arthritis (RA).
“As we look forward to the final safety and efficacy results later this year, Roche, Genentech and IDEC are working closely together to develop a global clinical development plan for the further study of Rituxan in RA,” said Susan D. Hellmann, M.D., MPH, Genentech’s executive vice president, Product Operations and Development, and chief medical officer.
RA is a debilitating disease that hinders the daily activities of sufferers. In 2000, there were 5.8 million patients worldwide with RA, a disease with no known cure. RA is characterized by inflammation of multiple joints, cartilage loss and bone erosion that leads to joint destruction and ultimately reduced joint function. Additionally, since RA is a systemic disease, it can have effects in other tissues such as the lungs, eyes and bone marrow. Fewer than 50 percent of patients who have had RA for more than 10 years can continue to work or function normally on a day-to-day basis.
Rituxan is indicated as a single-agent treatment for relapsed or refractory low-grade (indolent) or follicular, CD20 positive, B-cell NHL. More than 250,000 patients have been treated with Rituxan worldwide. Genentech and IDEC co-market Rituxan in the United States, Roche markets Rituxan in the rest of the world, and in Japan where Roche co-markets Rituxan with Zenyaku Kogyo Co. Ltd.
In non-Hodgkin’s lymphoma patients based on clinical trials and post-marketing experience, 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 in lymphoma patients 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 CLL. 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, Roche and IDEC
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Fifteen of the currently approved biotechnology products stem from or are based on Genentech science. Genentech manufactures and commercializes ten biotechnology products directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange under the symbol DNA.
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche’s innovative products and services address prevention, diagnosis and treatment of diseases, thus enhancing people’s well being and quality of life
IDEC Pharmaceuticals focuses on the commercialization and development of targeted therapies for the treatment of cancer and autoimmune diseases. IDEC's antibody products act chiefly through immune system mechanisms, exerting their effect by binding to specific, readily targeted immune cells in the patient's blood or lymphatic systems. IDEC is headquartered in San Diego, California, and is traded on the NASDAQ National Market System under the stock symbol, IDPH.
The statements made in this press release relating to the preliminary data from a Phase II study and the implementation of a global clinical development plan are forward-looking and the final data on the Phase II study or the actual implementation of the development plan could differ materially. Among other things, the final data results could differ from the preliminary data results, depending on the nature of the additional data collected and analyzed, and the feasibility and implementation of the development plan could change, depending on the final data results, among other things. These forward-looking statements represent the companies’ judgement as of the date of this release. The companies disclaim, however, any intent or obligation to update these forward-looking statements.
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For full prescribing information please call (650) 225-8681.
For more information, please visit www.rituxan.com.