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906Bexxar: Coulter Initiates Expanded Access Program

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  • Janice and Ben Haines
    Sep 28, 1998
    • 0 Attachment
      Monday September 28, 8:01 am Eastern Time

      Company Press Release

      Coulter Pharmaceutical Initiates Expanded Access Program

      PALO ALTO, Calif.--(BW HealthWire)--Sept. 28, 1998--Coulter Pharmaceutical
      Inc. (Nasdaq:CLTR - news) today announced that the company has initiated
      its Expanded Access Program for Bexxar(TM) (iodine I 131 tositumomab), the
      company's lead cancer therapeutic in development for the treatment of
      low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL).

      The program was established by the company in response to requests from
      physicians and patients for continued access to Bexxar during the period
      prior to potential FDA marketing approval.

      ``We are pleased to be able to respond to patients with the rapid
      initiation of our expanded access program,'' said Michael F. Bigham,
      president and chief executive officer of Coulter Pharmaceutical. ``The
      program will allow for the treatment of a broad patient population which
      will include relapsed and refractory patients with low-grade or transformed
      low-grade NHL who are seeking alternative therapy. In the process of
      supplying Bexxar for the program, we will gain substantial
      pre-commercialization experience in advance of potential marketing approval
      of the product.''

      The inclusion criteria for the expanded access program is broad, allowing
      for the treatment of low-grade or transformed low-grade NHL patients who
      have undergone at least one prior chemotherapy. The program will build
      gradually and is expected to eventually include over 100 community and
      academic oncology centers across the United States.

      Bexxar, which is an antibody conjugated to iodine 131, attaches to a
      protein found only on the surface of B-cells, including both non-Hodgkin's
      lymphoma B-cells and some normal B-cells. It is believed that through this
      targeted approach, the tumor cells receive a greater concentration of the
      therapeutic radiation from Bexxar relative to normal tissues.

      The antibody treatment is administered in a regimen which consists of two
      intravenous doses given about one week apart -- first a dosimetric dose
      followed by a therapeutic dose. This is in contrast to conventional
      chemotherapy where treatment is given repeatedly over several months.

      Non-Hodgkin's lymphoma is a form of cancer that affects the blood and lymph
      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
      270,000 people are afflicted with NHL in the United States alone. Of the
      total, the company estimates that approximately 140,000 people have
      low-grade or transformed low-grade disease. There are approximately 54,000
      new cases of NHL diagnosed each year.

      Coulter Pharmaceutical Inc. is engaged in the development of novel drugs
      and therapies for the treatment of people with cancer. The company
      currently is developing a family of cancer therapeutics based upon two drug
      development programs: therapeutic antibodies and targeted oncologics.

      The company's most advanced investigational product candidate is Bexxar(TM)
      (iodine I 131 tositumomab), a monoclonal antibody conjugated to a
      radioisotope. The company intends to file a BLA on Bexxar around year end
      1998. Initial efforts in the targeted oncologics program are focused on the
      development of a tumor-activated peptide pro-drug version of doxorubicin to
      potentially treat certain solid tumor cancers.

      Except for the historical information contained herein, the matters
      discussed in this news release are forward-looking statements 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 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 annual report on Form 10-K for the year ended
      December 31, 1997.


      Coulter Pharmaceutical Sylvia Wheeler, 650/842-7306