Data Show Improved Response Rate When Zevalin Plus Rituximab Follows Short Course First-Line Treatment in Patients with Follicular Lymphoma



    Biogen Idec (NASDAQ: BIIB) announced today that data presented at
    the 43rd American Society of Clinical Oncology (ASCO) annual meeting
    showed that adding Zevalin(R) (Ibritumomab tiuxetan)
    radioimmunotherapy to a short course first-line treatment followed by
    rituximab weekly for four weeks doubled the rate of complete response
    in patients with follicular lymphoma, from 44 percent with a standard
    treatment regimen to 88 percent. Additionally, the response rate
    (complete and partial responses) for patients in the study was 100
    percent based on PET scan assessment.

    "The increase in complete response rates when adding ZEVALIN
    radioimmunotherapy is promising," said Samuel A. Jacobs, M.D.,
    associate director for clinical investigations at the University of
    Pittsburgh Cancer Institute and UPMC Cancer Centers. "These data add
    to the growing body of evidence that using radioimmunotherapy as part
    of front-line treatment may increase complete response rates."

    About The Trial

    In this Phase II study, patients with symptomatic, stages II-IV
    and grades 1-3, untreated follicular lymphoma received three cycles of
    R-CHOP, a standard treatment regimen, followed by ZEVALIN. One week
    after ZEVALIN treatment, patients received rituximab weekly for four
    weeks. The primary endpoint of the trial was complete response rate,
    which was determined by CT scan, the conventional methodology, and PET
    scan. Of 56 evaluable patients, 50 completed both phases of therapy
    and were evaluated for response.

    Results evaluated by CT scan showed that 44 percent of patients
    had a complete response following the R-CHOP phase of treatment. After
    treatment with ZEVALIN and extended dose rituximab, complete response
    rate increased to 88 percent. Results evaluated by PET scan, a newer
    method of evaluation, showed a complete response rate of 68 percent
    with R-CHOP and 96 percent after treatment with ZEVALIN and extended
    dose rituximab. The response rate in patients who completed the
    treatment regimen was 100 percent based on PET scan assessment. Median
    time to progression has not yet been reached; to date, five patients
    have experienced disease progression. Adverse events included
    myelosuppression and there was one episode of febrile neutropenia
    after ZEVALIN and rituximab treatment.

    "We believe that ZEVALIN may play an important role in the
    treatment of lymphoma in the front-line setting and are encouraged
    that data continues to underscore the impact that radioimmunotherapy
    can have," said David Parkinson, M.D., senior vice president, Oncology
    Research and Development, Biogen Idec. "In order to further understand
    the potential of ZEVALIN as a first-line treatment, we have recently
    initiated a phase III trial that will evaluate ZEVALIN as part of
    first-line treatment with CVP, a commonly-used chemotherapy regimen."

    ZEVALIN Safety Profile

    Rare deaths have occurred within 24 hours of rituximab (RITUXAN)
    infusions. These fatalities were associated with an infusion reaction
    symptom complex that included hypoxia, pulmonary infiltrates, acute
    respiratory distress syndrome, myocardial infarction, ventricular
    fibrillation or cardiogenic shock. Yttrium-90 ZEVALIN administration
    results in severe and prolonged cytopenias in most patients. Patients
    experiencing severe cutaneous and mucocutaneous reactions should not
    receive any further components of the ZEVALIN therapeutic regimen and
    should seek prompt medical evaluation. In safety data based upon 349
    patients, the most serious adverse reactions of the ZEVALIN
    therapeutic regimen were primarily hematologic, with grade 3/4
    neutropenia, thrombocytopenia, and anemia occurring in 60 percent, 63
    percent and 17 percent respectively. Infusion-related toxicities were
    typically grade 1 or 2 and were associated with pre-administration of
    rituximab. The risk of hematologic toxicity correlated with the degree
    of bone marrow involvement prior to ZEVALIN therapy. Myelodysplastic
    syndrome (MDS) and/or acute myelogenous leukemia (AML) were reported
    in 5.2% (11/211) of patients enrolled in clinical studies and 1.5%
    (8/535) of patients included in the expanded-access trial, with median
    follow-up of 6.5 and 4.4 years, respectively. ZEVALIN should only be
    used by health care professionals qualified by training and experience
    in the safe use of radionuclides.

    About ZEVALIN

    On February 19, 2002, the ZEVALIN (Ibritumomab tiuxetan)
    therapeutic regimen was approved by the U.S. Food and Drug
    Administration (FDA) for the treatment of patients with relapsed or
    refractory low grade, follicular or transformed B-cell non Hodgkin's
    lymphoma (NHL), including patients with rituximab (RITUXAN) refractory
    follicular non-Hodgkin's lymphoma. Determination of the effectiveness
    of ZEVALIN in a relapsed or refractory patient population is based on
    overall response rates. The effects of ZEVALIN on survival are not
    known. Radioimmunotherapy offers an option to patients with certain
    types of B-cell non-Hodgkin's lymphoma who have failed to adequately
    respond to other cancer therapies.

    The ZEVALIN therapeutic regimen combines a monoclonal antibody
    with a radioisotope. The monoclonal antibody in ZEVALIN recognizes and
    attaches to a particular cell-surface protein on B-cells called the
    CD20 antigen. This allows ZEVALIN to specifically target B-cells,
    destroying malignant NHL B-cells and also normal B-cells.

    About Biogen Idec

    Biogen Idec creates new standards of care in oncology, neurology
    and immunology. As a global leader in the development, manufacturing,
    and commercialization of novel therapies, Biogen Idec transforms
    scientific discoveries into advances in human healthcare. For ZEVALIN
    product labeling, press releases and additional information about the
    company, please visit www.biogenidec.com.

    Biogen Idec Safe Harbor

    This press release contains forward-looking statements regarding
    ZEVALIN as a treatment for various indications. These statements are
    based on the companies' current beliefs and expectation. Drug
    development involves a high degree of risk. Factors which could cause
    actual results to differ materially from the companies' current
    expectations include: the risk that unexpected concerns may arise from
    additional data or analysis, that regulatory authorities may require
    additional information, further studies, or may fail to approve the
    drug, or that the company may encounter other unexpected hurdles. For
    more detailed information on the risks and uncertainties associated
    with Biogen Idec's drug development and other activities, see the
    periodic reports of Biogen Idec Inc. filed with the Securities and
    Exchange Commission. Biogen Idec assumes no obligation to update any
    forward-looking statements, whether as a result of new information,
    future events or otherwise.