Corixa and GlaxoSmithKline Announce the Completed Submission of Bexxar Data and
Documentation in Response to the U.S. FDA's Complete Review Letter
09/07/2001
Seattle and Philadelphia, September 7, 2001 – Corixa Corporation (Nasdaq: CRXA) and
GlaxoSmithKline (NYSE: GSK) today announced the companies have submitted the final
responses to information requested by the U.S. Food and Drug Administration (FDA) in its
Complete Review Letter received on March 16, 2001 regarding the Biologics License Application
(BLA) for Bexxar™ (tositumomab, iodine I 131 tositumomab). The companies are seeking
marketing approval of Bexxar for the treatment of relapsed or refractory, low-grade or transformed
low-grade non-Hodgkin’s lymphoma.
This submission includes answers to clinical questions such as independent oncologist/radiologist
reviews of clinical response data from two recently completed Bexxar trials, as well as technical
database information. On August 9, 2001, the companies announced they had submitted
responses to all information requested regarding the Chemistry, Manufacturing and Controls
sections of the BLA as well as most answers to questions raised regarding the clinical portion of
the filing.
Corixa expects the resubmission of its license application to be classified by the FDA as a Class II
response to the agency's Complete Review Letter. As a Class II response, the FDA may approve,
not approve, or request additional information at any time within six months from the resubmission
date.
“Submission of this final information to the FDA on the Bexxar BLA is an important milestone in
the regulatory process for this novel radioimmunotherapy,” said Steven Gillis, Ph.D., chairman and
chief executive officer of Corixa Corporation. “We look forward to the continued regulatory review
of Bexxar.”
About Corixa
Corixa is a developer of immunotherapeutics with a commitment to treating and preventing
autoimmune diseases, cancer and infectious diseases by understanding and directing the immune
system. Corixa is focused on immunotherapeutic products and has a broad technology platform
enabling both fully integrated vaccine design and the use of its separate, proprietary product
components on a stand-alone basis. Corixa currently has 16 programs in clinical development and
22 programs in preclinical development, including its most advanced product candidate, Bexxar,
a monoclonal antibody conjugated to a radioisotope.
The company partners with numerous developers and marketers of pharmaceuticals, targeting
products that are Powered by Corixa™ technology with the goal of making its potential products
available to patients around the world. Corixa was founded in 1994 and is headquartered in
Seattle, Washington, with additional operations in Hamilton, Montana and South San Francisco,
California. For more information, please visit Corixa's website at www.corixa.com or call the
company's investor relations information line at 1.877.4CORIXA or 1.877.426.7492.
About GlaxoSmithKline
GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare
companies-- is committed to improving the quality of human life by enabling people to do more,
feel better and live longer.
GlaxoSmithKline is committed to the research, development, manufacturing and marketing of
therapeutic and supportive care products for hematology and oncology patients. Currently,
GlaxoSmithKline Oncology markets Zofran® (ondansetron HCl), Hycamtin® (topotecan
hydrochloride), Navelbine® (vinorelbine tartrate) Injection, Argatroban Injection, Alkeran®
(melphalan), Leukeran® (chlorambucil), Compazine® (prochlorperazine), Purinethol®
(mercaptopurine), Myleran® (busulfan), and Thioguanine. GlaxoSmithKline Oncology has novel
agents in late-stage development, including a radioimmunotherapy Bexxar™ (tositumomab,
iodine 131 tositumomab). For company information, visit GlaxoSmithKline on the World Wide
Web at www.gsk.com. ... |
