Friday, Jul 25, 1997
San Diego and South San Francisco, Calif. -- July 25, 1997 --IDEC Pharmaceuticals Corporation (NASDAQ: IDPH) and Genentech, Inc. (NYSE: GNE) today announced that Rituxan (Rituximab), also known as IDEC-C2B8, a monoclonal antibody, was recommended unanimously for marketing clearance by the Biological Response Modifiers Advisory Committee (BRMAC) to the U.S. Food and Drug Administration (FDA). The proposed indication is for treatment of relapsed or refractory low grade or follicular B-cell non-Hodgkin's lymphoma.
In an open label multi-center pivotal trial, Rituxan, when used alone, induced tumor shrinkage of 50 percent or greater in 76 of 151 evaluable patients (50 percent response rate) following four weekly infusions. Thus far the median duration of response has not been reached after 9.2+ months since 48 percent of responders continue to have an ongoing response.
In clinical trials, most adverse events associated with Rituxan are infusion-related and are transient mild to moderate symptoms (e.g. fever, chills, headache). Infusion-related events occur with greatest frequency upon initial administration and are usually limited in duration to the period of the infusion. The symptoms decrease significantly with subsequent infusions. More serious events which occurred with less frequency included rigors, rash, hypotension, wheezing, infections, and recurrence of cardiac events in patients with a history of angina or arrhythmia.
"We are pleased the Advisory Committee recommended to the FDA marketing clearance of Rituxan. The proposed indication is for the treatment of patients with relapsed or refractory low grade or follicular B-cell non-Hodgkin's lymphoma," said Antonio J. Grillo-Lspez, M.D., IDEC's senior vice president of medical and regulatory affairs. "Rituxan may represent a new approach to cancer treatment; it harnesses the body's immune system to focus on and destroy cancer cells."
"The recommended clearance for marketing of Rituxan is an important milestone," said Susan Hellmann, M.D., M.P.H., Genentech's vice president of medical affairs and chief medical officer. "Patients may soon have a new treatment available to them, which takes less time to administer than conventional chemotherapy with less serious side effects."
Unlike the standard four- to six-month chemotherapy regimen or high-dose radiation, Rituxan treatment can be administered in four infusions one week apart on an outpatient basis during a 22-day period.
There are approximately 240,000 patients in the United States with B-cell non-Hodgkin's lymphomas, which are malignancies of the body's antibody-producing immune cells. Approximately one-half are low grade or follicular lymphoma patients who will experience multiple relapses during the average seven-year course of their incurable disease. Currently, standards of treatment consist of chemotherapy and/or radiotherapy, with their accompanying toxicity.
The role of the BRMAC is to make recommendations, which are not binding, to the FDA on the clinical sections of Biologic License Applications (BLAs). The BLAs submitted by both companies, including non-clinical sections, are currently under review by the FDA. If the FDA concurs with the Advisory Committee recommendation, Rituxan may become the first monoclonal antibody commercially available for the treatment of cancer in the United States. The FDA makes the final determination as to whether there is sufficient clinical data and compliance with all other requirements to support product licensure.
IDEC discovered Rituxan and developed the product in collaboration with Genentech and F. Hoffmann-La Roche Ltd of Switzerland, and Zenyaku Kogyo Co., Ltd. of Japan. IDEC and Genentech submitted Biologic License Applications (BLAs) jointly to the FDA to support their shared responsibility for product manufacture, and the companies will be co-promoting Rituxan in the United States. Roche will be responsible for marketing Rituxan in the rest of the world, excluding Japan.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. The company has headquarters in South San Francisco and is traded on the New York Stock Exchange and Pacific Exchange under the symbol GNE.
F. Hoffmann-La Roche Ltd, with headquarters in Basel, Switzerland, is a member of the Roche Group, a world leader in research-based health care with major businesses in pharmaceuticals, diagnostics, vitamins and fine chemicals, and fragrances and flavors. Roche has a long tradition of innovative breakthroughs in drug development and is a pioneer in the medical applications of genetic engineering.
IDEC Pharmaceuticals focuses on developing targeted immunotherapies for the treatment of cancer and autoimmune disease which are primarily designed to act through immune mechanisms. If Rituxan is licensed for marketing by the FDA, it will be IDEC's first marketed product. IDEC Pharmaceuticals is a registered U.S. trademark and Rituxan is a U.S. trademark of the company, which is headquartered in San Diego, California.
The statements made in this news release contain certain forward looking statements that involve a number of risks and uncertainties. Actual events or results may differ from IDEC's expectations. In addition to the matters described in this news release, ultimate licensing or the timing thereof by the FDA and approval by other regulatory agencies, as well as the risk factors listed from time to time in IDEC's SEC filings, including but not limited to its annual reports on Form 10-K for the year ended December 31, 1996 and Form 10-Q filed May 13, 1997, may affect the actual results achieved by IDEC.
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