CAMBRIDGE, Mass. and SAN DIEGO, Calif., Jan. 22 /PRNewswire-FirstCall/--
Biogen Idec (Nasdaq: BIIB) today 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(R) (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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031112/LAW121LOGO )
"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.
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 product labeling, press releases and additional
information about the company, please visit http://www.biogenidec.com.
For full prescribing information, including Boxed Warnings, please call 1-
877-878-4332. For more information on ZEVALIN, visit http://www.zevalin.com.
Media Contact:
Amy Ryan
Associate Director, Public Affairs
Biogen Idec
Tel: (617) 914-6524
Media Contact:
Anne Hyder
Manning, Selvage & Lee
Tel: (415) 364-3849
Investment Community Contact:
Christina Dillon
Manager, Investor Relations
Biogen Idec
Tel: (617) 679-2812
SOURCE Biogen Idec
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CONTACT:
Media, Amy Ryan , Associate Director, Public
Affairs, Biogen Idec, +1-617-914-6524; or Anne Hyder, Manning,
Selvage & Lee, +1-415-364-3849; or Investment Community,
Christina Dillon, Manager, Investor Relations, Biogen Idec,
+1-617-679-2812
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