(BW HealthWire) — IDEC Pharmaceuticals Corporation (Nasdaq: IDPH) today announced it expects to receive a Complete Review Letter tomorrow from the U.S. Food and Drug Administration (FDA) for the company’s Biologic License Application (BLA) for Zevalin(TM) (ibritumomab tiuxetan) radioimmunotherapy. The FDA is required to respond to IDEC by January 8, 2002 in order to meet its six-month review target suggested in the Prescription Drug User Fee Act (PDUFA).
Based on discussions with the FDA, the company has been informed that its BLA submission is deemed approvable and that no additional clinical data are required. However the FDA will delay granting marketing approval at this time pending resolution of certain manufacturing compliance issues at the company’s fill/finish provider.
“While we are disappointed that we will not be receiving final approval before the FDA’s action date as we had expected, we are nevertheless encouraged to learn that the data in our BLA are acceptable to the FDA and sufficient for approval,” said William H. Rastetter, Ph.D., chairman, chief executive officer and president of IDEC Pharmaceuticals. “We remain fully dedicated to obtaining approval of this important radioimmunotherapy as soon as possible and are working closely with the FDA and our fill/finish provider to ensure that the pending manufacturing compliance issues will be resolved. In the meantime, we are continuing to produce Zevalin kit components at our contract manufacturer in anticipation of approval and product launch.”
Zevalin is a monoclonal antibody linked to the radioisotope Yttrium-90, which targets the CD20 antigen on the surface of mature B cells and B-cell tumors, inducing cellular damage in the target and neighboring cells. Zevalin is an investigational radioimmunotherapeutic agent for the treatment of non-Hodgkin’s lymphoma (NHL), the fifth most common type of cancer diagnosed in the United States. For reasons that include the aging of the U.S. population, incidence of NHL has increased over the past 20 years. It is estimated that approximately 300,000 people are currently living with NHL in the U.S.
On Tuesday, January 8 at 4:00 p.m. Pacific Time, you may listen to a live webcast of Dr. Rastetter presenting at the 20th Annual J. P. Morgan H&Q Healthcare Conference by clicking on http://www.jpmhq.com. To register for the webcast type in your name, company and email. The webcast will be archived at http://www.jpmhq.com for three months.
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 system.
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. In particular, the timing and nature of the resolution of the manufacturing issues at the company’s third party manufacturer will depend on the ability of that party to demonstrate to the satisfaction of the FDA compliance with Good Manufacturing Practices (GMP). The failure to satisfy GMP requirements could delay approval and commercial launch of Zevalin. Reference is also made to 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, 2000 and Form 10-Q for the third quarter ended September 30, 2001, which may affect 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 is a registered U.S. trademark of the company. Zevalin is a trademark 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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