(BW HealthWire) — IDEC Pharmaceuticals Corporation (Nasdaq:IDPH) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval of ZEVALIN(TM) (Ibritumomab Tiuxetan). This radioimmunotherapy is proposed for the treatment of low grade or follicular, relapsed or refractory, CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) and Rituximab-refractory follicular NHL, which is cancer of the lymphatic system.
IDEC also noted the FDA had designated ZEVALIN a Fast Track Product for the treatment of relapsed or refractory, low grade or follicular NHL. Under the FDA Modernization Act of 1997, designation as a Fast Track Product means that the FDA will facilitate the development and expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition, and it demonstrates the potential to address unmet medical needs for such a condition.
Acceptance for review of the license application by the FDA will be determined within 60 days of submission.
“This submission is a tremendous achievement for IDEC and highlights our commitment to developing innovative and complementary therapies for the treatment of non-Hodgkin’s lymphoma,” said William H. Rastetter, IDEC’s chairman, chief executive officer and president. “This application is the result of the collective effort of hundreds of IDEC employees. Some have worked years to bring ZEVALIN to this stage, with the hope that ZEVALIN might benefit NHL patients.”
IDEC’s partner Schering A.G., which has worldwide marketing rights to ZEVALIN, except in the United States, also plans to submit a Marketing Authorization Application (MAA) for ZEVALIN to the European Medicines Evaluation Agency (EMEA).
Electronic Filing
IDEC’s ZEVALIN filing consists of seven compact disks (CDs) and approximately 30 more CDs of digitized computer tomography (CT) scans and nuclear medicine images. This is one of the first BLAs submitted to the FDA in a completely electronic format; no paper version is required to accompany the CDs.
The BLA submission is based on clinical data from two Phase III trials conducted by IDEC at approximately 30 medical sites in the United States. One pivotal trial was a randomized-controlled study of ZEVALIN versus a standard course of Rituxan(R) (Rituximab). The second trial studied ZEVALIN in Rituxan-refractory patients with follicular NHL. Data from both studies will be presented at the American Society of Hematology (ASH) in early December 2000.
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. For a menu of IDEC’s current news releases and quarterly reports or to retrieve a specific release, call (888) 329-2309. On the Internet check the News Center at IDEC’s website: http://idecpharm.cdmail.biz.
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 IDEC’s expectations. For example, the timing, success and cost of preclinical research and clinical studies, the timing, acceptability and review periods for regulatory filings, the timing of and ability to obtain regulatory approval of products, such as ZEVALIN, the achievement of future product sales, the level of manufacturing performance and the risk factors listed from time to time in IDEC’s SEC filings including but not limited to its Annual Report on Form 10-K for the year ended December 31, 1999 and Form 10-Q for the quarter ended June 30, 2000, may affect the actual results achieved by IDEC. These forward-looking statements represent the company’s judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
IDEC Pharmaceuticals and Rituxan are registered U.S. trademarks of the company. ZEVALIN is a trademark of the company. The company’s headquarters is located at 3030 Callan Road, San Diego, CA 92121.
IDEC Pharmaceuticals’ press releases are available at no charge through Business Wire’s News on Demand Plus. For a menu of IDEC’s current press releases and quarterly reports or to retrieve a specific release, call 888/329-2309. On the Internet, check the News Center at IDEC’s website http//idecpharm.cdmail.biz.
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