Coulter Pharmaceutical and SmithKline Beecham Announce the Submission of a Biologics License Application for Bexxar to FDA
SOUTH SAN FRANCISCO, Calif. & PHILADELPHIA--(BW HealthWire)--Sept. 18, 2000--Coulter Pharmaceutical, Inc. (Nasdaq:CLTR - news) and SmithKline Beecham (NYSE:SBH - news) today announced the re-submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Bexxar(TM) (tositumomab, iodine I 131 tositumomab). The companies are seeking marketing approval of Bexxar for the treatment of patients with relapsed or refractory, low-grade or transformed low-grade B-cell non-Hodgkin's lymphoma (NHL).
``We are pleased to have responded to all questions from the FDA that followed from our original submission,'' said Michael F. Bigham, president and chief executive officer of Coulter. ``We look forward to continue working closely with our partner SmithKline Beecham and the FDA to make Bexxar commercially available to the many NHL patients who may benefit from the therapy.''
Kevin Lokay, vice president and director of Oncology for SmithKline Beecham, said, ``We are proud to be working in partnership with Coulter on such an important and novel therapy as Bexxar. As a company committed to oncology, we look forward to providing a new treatment option to patients with non-Hodgkin's lymphoma.''
Bexxar has been designated a Fast Track Product by the FDA because one of the targeted indications for the therapy is transformed, low-grade non-Hodgkin's lymphoma, a life-threatening disease representing an unmet medical need. Because Bexxar is designated as a fast track product, the companies will request a Priority Review.
Bexxar is a radioimmunotherapy involving an antibody conjugated to iodine 131 (I-131) that attaches to a protein found only on the surface of B-cells, including non-Hodgkin's lymphoma B-cells. The properties of the I-131 radioisotope allow an appropriate patient-specific dose to be easily determined and administered. Bexxar is believed to work through multiple mechanisms of action resulting from immune system activity of the monoclonal antibody and the therapeutic effects of the I-131 radioisotope. Through the targeted approach of Bexxar, the tumor cells receive a greater concentration of the therapeutic radiation whereas the radiation to normal tissues is minimized.
Non-Hodgkin's lymphoma is a form of cancer that affects the blood and lymphatic tissues. NHL currently is the sixth leading cause of death among cancers in the United States and has the second fastest growing mortality rate. According to statistics from the National Cancer Institute, approximately 300,000 people are afflicted with NHL in the United States alone. It is estimated that approximately 140,000 people have low-grade or transformed low-grade disease, and 120,000 people have intermediate-grade disease.
Coulter Pharmaceutical, Inc. is engaged in the development of novel drugs and therapies for the treatment of cancer and autoimmune diseases. The company currently is developing a family of therapeutics based upon two drug development programs: therapeutic antibodies and targeted oncologics. The company's most advanced product candidate is Bexxar(TM), a monoclonal antibody conjugated to a radioisotope. The company's therapeutic antibodies program also includes an interferon receptor antagonist. Initial efforts in the targeted oncologics program are based on tumor activated prodrug (TAP) and tumor-specific targeting (TST) technologies. For more company information, visit Coulter Pharmaceutical's web site at coulterpharm.com.
SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products. For company information, visit SmithKline Beecham on the World Wide Web at sb.com.
SmithKline Beecham Oncology is committed to the research, development, manufacturing and marketing of therapeutic and supportive care products in oncology. Currently, SB Oncology markets Hycamtin® (topotecan hydrochloride), Kytril® (granisetron hydrochloride) and Compazine® (prochlorperazine), and has novel agents in development.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements for Coulter Pharmaceutical, Inc. that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of Bexxar(TM) or the company's other product candidates and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission (SEC). In particular, see ``Risk Factors'' in the company's Registration Statement on Form S-3 filed Aug. 30, 2000, and Annual Report on Form 10-K for the year ended Dec. 31, 1999.
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, SmithKline Beecham cautions investors that any forward-looking statements or projections made by the company, including those made in this news release, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the company's operations are discussed in Exhibit 99 to the company's Annual Report on Form 20-F for 1999, filed with the U.S. Securities and Exchange Commission.
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