Idec Pharma.: Weiß jemand über FDA-Genehmingung Bescheid? - 500 Beiträge pro Seite

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( BW)(CA-IDEC-PHARMACEUTICALS)(IDPH) FDA Advisory Committee Panel
Recommends Approval of ZEVALIN for Treatment of Certain Non-Hodgkin`s
Lymphomas

Business Editors/Health & Medical Writers
BIOWIRE2K

SAN DIEGO--(BW HealthWire)--Sept. 11, 2001--IDEC Pharmaceuticals
Corporation (NASDAQ: IDPH) announced today that the Oncologic Drugs
Advisory Committee (ODAC) of the U.S. Food and Drug Administration
(FDA) recommended approval of ZEVALIN(TM) (Ibritumomab Tiuxetan), an
investigational agent, for the proposed treatment of
rituximab-refractory follicular, B-cell non-Hodgkin`s lymphoma (NHL).
With respect to the use of ZEVALIN for treatment of patients that
are not rituximab-refractory, that is, patients with relapsed or
refractory, low grade, follicular or CD20-positive transformed, B-cell
NHL, the Committee recommended that the FDA consider approval of
ZEVALIN in this indication under the agency`s accelerated approval
regulations. While the ZEVALIN BLA was not filed under the accelerated
approval regulations, given the Committee`s recommendations, the
Company will discuss with the FDA the merits of an accelerated
approval approach for ZEVALIN and its implications on product labeling
and the timing of BLA approval.
The Advisory Committee consists of individuals recognized as
experts in various fields including medicine, science and research,
industry, and consumer/patient advocacy. While the Committee`s
recommendations are a milestone, the FDA will determine the
applicability of the accelerated approval regulations and will make
the final decision whether or not to approve ZEVALIN. IDEC will
continue to work with the FDA to implement the Advisory Committee`s
recommendations.
"We are delighted the Advisory Committee recommended approval of a
first-in-class radioimmunotherapy," said William H. Rastetter, Ph.D.,
Chairman, Chief Executive Officer and President of IDEC. "ZEVALIN
represents years of tireless work on the part of hundreds of IDEC
employees. If approved by the FDA, we believe ZEVALIN will provide a
potential treatment alternative for certain non-Hodgkin`s lymphoma
patients."
Christine A. White, M.D., IDEC`s Vice President of Medical
Affairs, gave the Company`s scientific and medical presentation of
ZEVALIN data to the ODAC panel. More than 500 NHL patients have been
treated with ZEVALIN in clinical trials sponsored by IDEC throughout
the U.S.
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://www.idecpharm.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 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, 2000 and Form 10-Q for the quarter ended June 30, 2001,
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 is a registered U.S. trademark of the
Company. ZEVALIN is a trademark of the Company. Rituxamab is the
generic name for the Company`s approved drug Rituxan(R), a registered
U.S. trademark. The Company`s headquarters are 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://www.idecpharm.com.