(BW HealthWire) — IDEC Pharmaceuticals Corporation (Nasdaq: IDPH) today announced it received the Complete Review Letter today from the U.S. Food and Drug Administration (FDA) for the company’s Biologic License Application (BLA) for Zevalin(TM) (ibritumomab tiuxetan) radioimmunotherapy. As announced yesterday, the company expected to receive the Complete Review Letter today in order for the FDA to meet its six-month review target suggested in the Prescription Drug User Fee Act (PDUFA).
The Complete Review Letter confirms that the company’s investigational agent Zevalin is approvable pending resolution of certain manufacturing compliance issues at the company’s fill/finish provider, and that no additional clinical data are required. In addition, the letter stated that all labeling issues have been resolved.
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 Wednesday, January 9 at 8:00 a.m. Pacific Time, you may listen to a live webcast of IDEC senior management discussing the Complete Review Letter at idecpharm.cdmail.biz. From the IDEC website, go to Investor Relations for the live webcast. The conference call will be archived on the website for 48 hours.
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
News provided by COMTEX. User agreement applies