Hi Bennett, not necessary the news !
IDEC-C2B8 SCHEDULED FOR JULY 25 FDA ADVISORY
COMMITTEE MEETING
SAN DIEGO--(BW HealthWire)--June 19, 1997--IDEC Pharmaceuticals (NASDAQ:IDPH) announced
today that the U.S. Food and Drug Administration (FDA) has scheduled its Biologics License Application
(BLA) for IDEC-C2B8 (rituximab) for review by the FDA's Biological Response Modifiers Advisory
Committee on Friday, July 25, 1997. The BLAs for use of IDEC-C2B8 were submitted by IDEC and
Genentech, its development partner, on February 28, 1997. The companies are seeking an indication for
relapsed low grade or follicular non-Hodgkin's lymphoma.
The presentation and Committee discussion on IDEC-C2B8 will begin at 8 a.m. EST at the Holiday Inn,
Bethesda, Maryland.
Although the FDA Advisory Committee meeting is an important milestone in the FDA review process, the
final decision regarding marketing approval of new therapeutics resides with FDA officials subsequent to
the recommendation of the Committee.
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 therapies for the treatment of cancer and
autoimmune diseases. IDEC's 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.
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, see businesswire.com and
shareholdernews.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, time lines for clinical ongoing activity are subject to change,
results of pending or future clinical trials cannot be accurately predicted and decisions by the FDA and
other regulatory agencies, as well as the risk factors listed from time to time in the company's Securities
and Exchange Commission filings, including but not limited to its Annual Reports on Form 10-K for the
year ended Dec. 31, 1996, 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, Calif. 92121. |
