Coulter Pharmaceutical and SmithKline Beecham Announce Priority Review Status for Bexxar
Thursday October 5, 7:54 am Eastern Time
Press Release
Coulter Pharmaceutical and SmithKline Beecham Announce Priority Review Status for Bexxar
SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--Oct. 5, 2000--Coulter Pharmaceutical, Inc. (Nasdaq:CLTR - news) and SmithKline Beecham (NYSE:SBH - news) today announced that Bexxar(TM) (tositumomab, iodine I 131 tositumomab) has been assigned priority review status by the U.S. Food and Drug Administration (FDA).
With priority review status, the license application for Bexxar will be reviewed and action taken by the agency within six months from the date of submission. The companies are seeking marketing approval of Bexxar for the treatment of relapsed or refractory, low-grade or transformed low-grade B-cell non-Hodgkin's lymphoma. If approved, Bexxar could be the first approved radioimmunotherapy to become commercially available.
``We are pleased that Bexxar has been awarded priority review status,'' said Michael F. Bigham, president and chief executive officer of Coulter. ``The commitment by the FDA for an expeditious review of our license application moves us one important step closer to providing this novel therapy to patients.''
On September 15, 2000, Coulter and SmithKline submitted a Biologics License Application (BLA) to the FDA for Bexxar. The therapy has been designated a Fast-Track product 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. The FDA is expected to determine acceptability of the license application within 60 days of the submission.
``SmithKline Beecham is committed to developments in oncology and is dedicated to bringing novel therapies like Bexxar to market,'' said Kevin Lokay, vice president and director of Oncology for SmithKline Beecham. ``Our goal is to continue to work with our partner Coulter Pharmaceutical to ensure that Bexxar is made available for patients suffering from this devastating disease.''
Bexxar is a radioimmunotherapy involving an antibody conjugated to iodine 131 that attaches to a protein found only on the surface of B-cells, including non-Hodgkin's lymphoma B-cells. 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 iodine (I-131) radioisotope. Through Bexxar's targeted approach, the tumor cells receive a greater concentration of the therapeutic radiation while minimizing the radiation to normal tissues.
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.
Coulter and SmithKline Beecham (SB) established a partnership to jointly develop and market Bexxar in the United States following regulatory approval with the two companies sharing equally in profits. Coulter holds exclusive rights to Bexxar outside the United States.
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 htttp://www.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, and provides healthcare services including laboratory testing and disease management. For company information, visit SmithKline Beecham on the World Wide Web at sb.com.
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 August 30, 2000, and Annual Report on Form 10-K for the year ended December 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 1998, filed with the U.S. Securities and Exchange Commission.
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Contact:
Coulter Pharmaceutical, Inc.
Sylvia Wheeler, 650/553-2000
or
SmithKline Beecham
Jennifer Armstrong, 215/751-5664
Tom Curry, 215/751-5419
or
Abenaa Hayes, 212/598-2827 |
