Wednesday, Aug 17, 2005
South San Francisco, Calif. and Cambridge, Mass. -- August 17, 2005 --Genentech, Inc. (NYSE: DNA), Biogen Idec, Inc. (Nasdaq: BIIB) and Roche (SWX Zurich) today announced that the companies completed the filing of a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for an additional indication for Rituxan® (Rituximab), in previously untreated (front-line) patients with intermediate grade or aggressive, CD-20-positive, B-cell, non-Hodgkin's lymphoma (NHL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens. As part of the Rituxan sBLA filing, the companies have requested Priority Review designation from the FDA. Rituxan is currently approved for use in relapsed or refractory, low-grade or follicular, CD-20-positive, B-cell, non-Hodgkin's lymphoma.
The sBLA filing is based on efficacy and safety data from three randomized, controlled, multicenter studies of Rituxan in combination with CHOP or other anthracycline-based chemotherapy induction regimens in 1,854 previously untreated patients with intermediate grade or aggressive, CD-20-positive, B-cell, non-Hodgkin's lymphoma. All three trials evaluated the efficacy endpoint of overall survival.
"These three Phase III studies add to the body of data regarding Rituxan in the treatment of non-Hodgkin's lymphoma," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. "We are pleased to be filing these data with the FDA, and we are committed to working closely with the agency during the review process."
"The addition of Rituxan to CHOP represents the first significant improvement in intermediate grade or aggressive CD-20-positive, B-cell NHL treatment since the development of the CHOP regimen more than 30 years ago," said Burt Adelman, M.D., Biogen Idec's executive vice president, Development.
The studies included in this filing are ECOG 4494 (a National Cancer Institute-sponsored intergroup trial led by the Eastern Cooperative Oncology Group), GELA/LNH 98-5 (the Group d Etude des Lymphome d Adulte) and MInT (MabThera International Trial M39045).
Study E4494 was designed to evaluate the efficacy and safety of Rituxan combined with induction CHOP chemotherapy in 632 patients 60 years of age or older with intermediate-grade or aggressive, CD-20-positive, B-cell, NHL.
The LNH 98-5 trial conducted by GELA was designed to evaluate the efficacy and safety of Rituxan in combination with induction CHOP chemotherapy in 399 patients 60 years of age or older with Diffuse Large B-Cell Lymphoma (DLBCL). Based on the results of this trial, in March 2002, Rituxan, which is known as MabThera® in Europe received approval from the European Union health authority to treat aggressive NHL.
The M39045 (MInT) trial was designed to evaluate the efficacy and safety of Rituxan in combination with CHOP or other anthracycline-based induction chemotherapy regimens in 823 patients between the ages of 18-60.
About Non-Hodgkin's Lymphoma
There are currently more than 360,000 people in the United States living with NHL. Approximately 50 percent have aggressive NHL, while the other half are patients with indolent or follicular lymphoma. According to the American Cancer Society, more than 56,000 men and women in the United States are diagnosed with NHL each year.
Rituxan Safety Profile
Rituxan is generally well tolerated by 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 (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.
Rituxan received U.S. Food and Drug Administration approval in November 1997 for the treatment of relapsed or refractory low-grade or follicular, CD-20-positive, B-cell, non-Hodgkin's lymphoma (NHL). It also was approved in the European Union under the trade name MabThera® in June 1998. Rituxan has been used to treat more than 730,000 patients worldwide.
Rituxan is a therapeutic antibody that targets and selectively depletes CD-20-positive B-cells without targeting stem cells or existing plasma cells. In April 2005, the companies announced positive findings from a Phase III study evaluating the safety and efficacy of Rituxan in patients with active rheumatoid arthritis (RA) who had an inadequate response or were intolerant to prior treatment with one or more anti-TNF therapies. Rituxan is also being investigated in other autoimmune diseases, including lupus, multiple sclerosis and ANCA-associated vasculitis.
About Genentech BioOncology
Genentech is committed to changing the way cancer is treated by establishing a broad oncology portfolio of innovative, targeted therapies with the goal of improving patients' lives. The company is the leading provider of anti-tumor therapeutics in the United States. Genentech is leading clinical development programs for Rituxan® (Rituximab), Herceptin® (Trastuzumab), Avastin (bevacizumab) and Tarceva® (erlotinib), and markets all four products in the United States alone (Avastin and Herceptin), with Biogen Idec Inc. (Rituxan) or with OSI Pharmaceuticals (Tarceva). Genentech has licensed Rituxan, Herceptin, and Avastin, and OSI Pharmaceuticals has licensed Tarceva to Roche for sale by the Roche Group outside of the United States.
The company has a robust pipeline of potential oncology therapies with a focus on four key areas: angiogenesis, apoptosis (i.e. programmed cell death), the HER pathway and B-cell biology. Potential oncology therapies directed at the HER pathway include a therapeutic antibody currently in Phase II trials. Also in early development are a small molecule directed at the hedgehog pathway, a soluble human protein targeting apoptosis and a humanized anti-CD20 antibody for hematology/oncology indications.
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, 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.
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics.
As a supplier of innovative products and services for the early detection, 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 is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totaled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.
For full prescribing information, including Boxed Warnings for Avastin, Rituxan and Herceptin, or for Tarceva full prescribing information, please call 800-821-8590 or http://www.gene.com.