(BW HealthWire) — IDEC Pharmaceuticals Corporation (Nasdaq: IDPH) announced today that the European launch of Zevalin(TM) (ibritumomab tiuxetan) by its partner Schering AG will be delayed due to certain technical compliance issues at the fill/finish provider. These issues are the subject of ongoing discussions between Schering and the European regulatory authorities. Schering had originally hoped to launch the product in the second half of 2002.
“Schering is examining all options to make this therapy available to patients as fast as possible,” said Dr. Joachim-Friedrich Kapp, Head of Schering AG’s Specialized Therapeutics business area. “Zevalin is the first radioimmunotherapy treatment for certain non-Hodgkin’s lymphomas and represents a significant step forward in the treatment of this disease. As the clinical efficacy of Zevalin is not in question we are confident to be able to launch Zevalin by the second half of 2003.”
Zevalin, an anti-CD-20 antibody labeled with Yttrium 90, targets the CD20 antigen on the surface of the mature B-cells and B-cell tumors, inducing cellular damage in the target and neighboring cells.
Zevalin was approved for marketing by the U.S. Food and Drug Administration (FDA) in February 2002. IDEC has exclusive rights to market Zevalin in the U.S. and Schering has exclusive marketing and distribution rights outside the U.S.
IDEC will provide any updates in its regularly scheduled quarterly conference call on July 17, 2002 at 1:30 p.m. Pacific Standard Time.
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, acceptability and review periods for regulatory filings, the timing of and ability to obtain regulatory approval of products, 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, 2001 and Form 10-Q for the first quarter ended March 31, 2002, 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 Zevalin are trademarks of the company. The company’s headquarters are located at 3030 Callan Road, San Diego, CA 92121.CONTACT: IDEC Pharmaceuticals Corporation Vince Reardon, Director, Corporate Communications 858/431-8656
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