Monday, Mar 3, 1997
San Diego and South San Francisco, Calif. -- March 3, 1997 --IDEC Pharmaceuticals Corporation (NASDAQ: IDPH) and Genentech, Inc. (NYSE: GNE) today announced the submission of Biological License Applications (BLA) to the U.S. Food and Drug Administration (FDA) for IDEC-C2B8 (rituximab) as a single agent therapy for the treatment of relapsed low grade or follicular non-Hodgkin's lymphoma. F. Hoffmann-La Roche Ltd, Basel, Switzerland, also submitted, through one of its subsidiaries in the European Union, a Marketing Authorization Application (MAA) with the European Medicines Evaluation Agency (EMEA) for marketing IDEC-C2B8 in Europe.
If IDEC-C2B8 is licensed for marketing, it would be the first available therapeutic monoclonal antibody for the treatment of cancer in the U.S. It would also be the first marketed product for IDEC. These submissions occur less than two years after the start of the development collaboration between Genentech and IDEC.
The applications are based on Phase III results which confirmed the Phase II data of the monoclonal antibody. These Phase III results were presented at the annual meeting of the American Society of Hematology (ASH) in December 1996. In the Phase III study of IDEC-C2B8 used alone, 50% or 76 of the 151 evaluable patients experienced tumor shrinkage of 50% or greater following four weekly infusions with IDEC-C2B8. Of the responding patients, 70% were still in remission at over nine months' median follow-up. Patients continue to be followed.
The most common adverse events associated with IDEC-C2B8 are usually infusion-related. These side effects consist primarily of mild to moderate flu-like symptoms (e.g., fever, chills) and occur with greatest frequency upon initial administration. The symptoms are limited in duration to the period of infusion and decrease significantly with subsequent infusions.
"The Phase III clinical results confirmed IDEC-C2B8's potential as an effective therapy with limited toxicity for patients with relapsed low grade or follicular B-cell lymphoma," said Antonio J. Grillo-Lopez, M.D., IDEC's senior vice president of medical and regulatory affairs.
"Genentech, Roche and IDEC are working in close collaboration to establish this important and novel therapy for non-Hodgkin's lymphoma patients who have failed standard treatment regimens," said Susan Hellmann, M.D., Genentech's vice president of medical affairs and chief medical officer. "The companies are also committed to continued exploration of further uses of IDEC-C2B8, as a frontline therapy, in combination with other anti-cancer treatments, and in intermediate and high grade disease."
There are approximately 240,000 patients in the U.S. with non-Hodgkin's B-cell lymphomas, which are malignancies of the body's antibody-producing immune system cells. Two-thirds are low grade or follicular lymphoma patients who will experience multiple relapses over the average six- to seven- year course of their incurable disease. Currently, standard treatment consists of chemotherapy and/or radiotherapy with accompanying toxicities.
IDEC and Genentech are developing IDEC-C2B8 in collaboration with F. Hoffmann-La Roche Ltd of Switzerland and Zenyaku Kogyo Co. Ltd. of Japan. IDEC and Genentech will be co-promoting IDEC-C2B8 in the United States. Both companies submitted BLA applications jointly to support their shared responsibility for product manufacture. Roche will be responsible for marketing IDEC-C2B8 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, California and is traded on the New York and Pacific Stock Exchanges under the symbol GNE.
IDEC Pharmaceuticals focuses on developing targeted immunotherapies for the treatment of cancer and autoimmune diseases. IDEC's products are primarily designed to act through immune mechanisms and offer greater specificity of action, longer therapeutic effect and lower toxicity than is typical of existing therapies. All of IDEC's products are designed for administration in outpatients settings, providing the opportunity to reduce overall treatment costs.
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' press releases are available at no charge through PR Newswire's "Company News on Call" fax service. For a menu of IDEC's current press releases and quarterly reports or to retrieve a specific release, call (800) 758-5805, ext. 432581. On the internet see http://www.shareholdersnews.com.
The statements made in this press release contain certain forward looking statements that involve a number of risks and uncertainties. Actual events or results may differ from the company's expectations. In addition to the matters described in this press release, the acceptability of the BLA submission, the timeline for its review, and the ultimate approvability thereof by the FDA and other regulatory agencies, as well as the risk factors listed from time to time in the company's SEC filings, including but not limited to its Annual Reports on Form 10-K for the year ended December 31, 1995, and Form S-3 filed May 3, 1996, may affect the actual results achieved by the company.
IDEC Pharmaceuticals is a registered U.S. trademark of the company. The company headquarters is located at 11011 Torreyana Road, San Diego, CA 92121.
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