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Business Editors, Health/Medical Writers
SOUTH SAN FRANCISCO, Calif. & PHILADELPHIA–(BW HealthWire)–July 26, 2000
Coulter Pharmaceutical (Nasdaq:CLTR) and SmithKline Beecham (NYSE:SBH) today announced that the U.S. Patent and Trademark Office has issued another patent relating to CD20 antibody therapy for the treatment of lymphoma.
The newest patent, number 6090365, is a method-of-use patent relating to the administration of antibodies that bind to the CD20 antigen present on lymphoma cells and used in a combination protocol. The combinations may include a CD20 antibody with a chemotherapeutic agent, an antibody-radioisotope conjugate, or external beam radiation.

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“With the addition of this patent to our portfolio, we continue to strengthen our proprietary position in the promising field of radioimmunotherapy,” said Michael F. Bigham, president and chief executive officer. “By proactively protecting our scientific innovations and know-how, we are better prepared to maintain our proprietary position in a competitive commercial field.”
The companies are jointly developing Bexxar(tm) (tositumomab, iodine I 131 tositumomab), a radioimmunotherapy not yet approved for the treatment of relapsed or refractory, low-grade or transformed low-grade B-cell non-Hodgkin’s lymphoma.
The newly issued patent builds on the companies’ proprietary position by focusing on methods for the treatment of lymphoma including the administration of a CD20 antibody in combination with a therapy which may include a chemotherapeutic agent, a non-CD20 antibody-radioisotope conjugate, external beam radiation, or another treatment which induces apoptosis in lymphoma cells. The combinations can be given in any order or concurrently. Also included in this patent are claims relating to a method of treatment involving the administration of an unlabelled CD20 antibody followed by a radioisotope-conjugated CD20 antibody.
In February 2000, the companies announced the issuance of a composition patent relating to radiolabeled monoclonal antibodies for the treatment of B-cell lymphomas. In December 1998, Coulter was awarded a patent for methods for administering and dosing radioimmunotherapy for the treatment of B-cell lymphomas. That patent relates to methods for blocking non-tumor binding sites as well as simple methods for determining appropriate dosing based on antibody distribution and metabolism of each individual patient. Coulter and SmithKline Beecham believe that these patents already provide protection of their methods and know-how, specifically in determining appropriate patient-specific doses of a CD20 antibody and its conjugate adjusted for individual pharmacokinetic variability.
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 in 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.
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 http://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. For company information, visit SmithKline Beecham on the World Wide Web at http://www.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(R) (topotecan hydrochloride), Kytril(R) (granisetron hydrochloride) and Compazine(R) (prochlorperazine), and has novel agents in development.