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EUROPEAN COMMISSION APPROVES ZEVALIN RADIOIMMUNOTHERAPY.

Biogen Idec (NASDAQ: BIIB) has announced that the European Commission has granted marketing approval for ZEVALIN(r) (Ibritumomab tiuxetan) radioimmunotherapy. ZEVALIN is approved in Europe for the treatment of adult patients with CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL) who are refractory to or have relapsed following RITUXAN (rituximab) therapy. ZEVALIN was approved in February 2002 by the U.S. Food and Drug Administration (FDA). It is marketed and distributed by Biogen Idec in the U.S. Schering AG, Biogen Idec's corporate partner, holds marketing and distribution rights for ZEVALIN outside the U.S. and expects to launch the product in Europe within the next few months.

"ZEVALIN radioimmunotherapy represents a major advancement in the treatment of certain non-Hodgkin's lymphomas," said Burt Adelman, executive vice president, Development for Biogen Idec. "We are pleased that through this partnership with Schering AG, patients in Europe will soon have access to this innovative therapy."

Radioimmunotherapy is a new area of cancer treatment that combines the targeting power of monoclonal antibodies with the cell-damaging ability of localized radiation. ZEVALIN is made by linking monoclonal antibodies to radioactive isotopes. When infused into a patient, these radiation-carrying antibodies circulate in the body until they locate and bind to the surface of specific cells, and then deliver their cytotoxic radiation directly to malignant cells. ZEVALIN binds to malignant and normal B-cells. Normal B-cells generally are replenished by CD20-negative progenitor cells within six-to-nine months following therapy.

About Clinical Studies

Extensive clinical studies of ZEVALIN have confirmed high response rates and durable responses in patients with relapsed, refractory follicular or transformed B-cell NHL.

* In a Phase 2 study evaluating patients with follicular NHL who did not respond to or responded inadequately to RITUXAN, ZEVALIN produced an overall response rate of 74 percent, with 15 percent of patients achieving a complete remission (disappearance of all evidence of disease), according to International Workshop Response Criteria (IWRC).

* A pivotal Phase 3 randomized, controlled trial was conducted in 143 patients with relapsed or refractory, low-grade or follicular NHL or transformed B-cell NHL. The 73 patients who received the ZEVALIN regimen showed an overall response rate of 80 percent, compared to 56 percent in the 70 patients who received RITUXAN alone. Thirty percent of ZEVALIN patients achieved a complete remission and 4 percent achieved an unconfirmed complete remission to therapy, compared to 16 percent of RITUXAN patients who achieved a complete remission and 4 percent who achieved an unconfirmed complete remission. The improvement in ORR and CR were statistically significant.

* ZEVALIN has been shown to induce durable remissions in many patients with relapsed or refractory B-cell NHL, as evidenced by long-term follow-up of complete responders from four registrational clinical trials. The median duration of remission for these patients approached two years, with some responses still ongoing at 75 months (6.25 years).

* Thirty-seven percent of the responding patients treated in the registrational trials achieved long-term responses, defined as time to progression of longer than 12 months. Among these long-term responders, the median duration of response was 28.1 months.

* The registrational trials of ZEVALIN involved more than 30 academic and community cancer centers in the U.S. and included the only randomized clinical trial to date comparing radioimmunotherapy to another standard therapy. A high proportion of the patients in the trials were greater than 60 years old and had received three or more prior therapies.

Schering AG, Germany is currently investigating the use of ZEVALIN in the treatment of aggressive NHL (i.e., diffuse large B-cell lymphoma) and as consolidation therapy for follicular NHL in earlier disease stages.

About ZEVALIN

On February 19, 2002, the FDA approved ZEVALIN, a new type of targeted cancer therapy called radioimmunotherapy, making it the first commercially available radioimmunotherapy for the treatment of B-cell non-Hodgkin's lymphoma (NHL). A unique treatment regimen for patients with certain types of B-cell NHL, the ZEVALIN therapeutic regimen combines a monoclonal antibody with a radioisotope. The monoclonal antibody in ZEVALIN recognizes and attaches to a particular cell-surface part of a B-cell called the CD20 antigen. This allows ZEVALIN to specifically target B-cells, destroying the malignant NHL B-cells and also normal B-cells. ZEVALIN, as part of the ZEVALIN therapeutic regimen, is indicated in the U.S. for the treatment of relapsed, or refractory low-grade, follicular or transformed B-cell NHL, including patients with RITUXAN refractory follicular NHL.

Today, ZEVALIN is being investigated in multiple clinical trials at major medical centers in the U.S. and in a variety of treatment strategies, including combinations with front-line and salvage chemotherapy regimens and as part of autologous and allogeneic stem cell transplantation.

ZEVALIN Safety Profile

In safety data based upon 349 patients, the most serious adverse reactions of the ZEVALIN therapeutic regimen were primarily hematologic, with grade 4 neutropenia, thrombocytopenia, and anemia occurring in 30 percent, 10 percent and 3 percent of patients treated at the 0.4 mCi/kg dose, respectively. Infusion-related toxicities were typically grade 1 or 2 and were associated with pre-administration of Rituximab (RITUXAN). The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to ZEVALIN therapy. Seven percent of patients were hospitalized with infection or febrile neutropena (3 percent) and fatal cerebral hemorrhage (less than 1 percent) has occurred in a minority of patients in clinical studies. The annualized rate for the development of treatment-related myelodysplasia or acute myelogenous leukemia is less than 1 percent of patients and can occur at 8 to 34 months after treatment.

ZEVALIN should only be used by health care professionals qualified by training and experience in the safe use of radionuclides. Fatal Infusion Reactions: Rare deaths have occurred within 24 hours of Rituximab 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. Prolonged and Severe Cytopenias: Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients.

For full prescribing information, including Boxed Warnings, call 1-877-878-4332. For more information on ZEVALIN, visit http://www.zevalin.com.

About Biogen Idec

Biogen Idec creates new standards of care in oncology 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 more information, visit http://www.biogenidec.com or call 617/679-2812.
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Publication:Worldwide Biotech
Date:Mar 1, 2004
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