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Datum nieuwsfeit: 16-11-2005
Positieve resultaten van Phase III onderzoek Rituxan bij rheumatoïde arthritis gepresenteerd op vergadering American College of Rheumatology
( BW)(CA-BIOGEN-IDEC/ROCHE)(BIIB) Positive Results of Phase III Study
of Rituxan in Rheumatoid Arthritis To Be Presented at American College
of Rheumatology Meeting
Pharmaceutical Writers/Biotech Writers/Health Editors
BIOWIRE2K
ACR Annual Scientific Meeting
SAN DIEGO--(BUSINESS WIRE)--Nov. 16, 2005--
Study Shows a Greater Proportion of Rituxan-Treated Patients
Achieved American College of Rheumatology 20, 50 and 70 Responses
Compared to Placebo
Biogen Idec (Nasdaq: BIIB) and Roche (SWX Zurich) today announced
positive results of a Phase III clinical study of Rituxan(R)
(Rituximab) in rheumatoid arthritis (RA), showing that a significantly
greater proportion of patients who received a single course of two
infusions of Rituxan with a stable dose of methotrexate (MTX) achieved
American College of Rheumatology (ACR) 20, 50 and 70 response rates
compared to patients who received placebo and MTX. The study included
patients with active RA who have had an inadequate response or were
intolerant to prior treatment with one or more anti-TNF therapies.
These data were submitted to the U.S. Food and Drug Administration
(FDA) as part of a supplemental Biologics License Application for
Rituxan that is currently under Priority Review. These findings will
be presented today during a plenary session at the ACR Annual
Scientific Meeting in San Diego.
In the 24-week multi-center, double-blind, and placebo-controlled
study, known as REFLEX, 520 patients were randomized to receive either
Rituxan or placebo, in combination with a stable dose of MTX. At 24
weeks, those receiving Rituxan displayed clinically and statistically
significant improvements in RA symptoms compared to placebo. In
patients receiving Rituxan:
-- 51 percent achieved ACR 20, the primary endpoint of the study,
versus 18 percent of placebo patients;
-- 27 percent achieved ACR 50, versus 5 percent of placebo
patients;
-- 12 percent achieved ACR 70, versus 1 percent of placebo
patients.
"Few options exist for patients who inadequately respond to
anti-TNF therapy," said abstract lead author and presenter Stanley B.
Cohen, M.D., Clinical Professor of Internal Medicine, University of
Texas, Southwestern Medical School. "We are encouraged that these
pivotal data from REFLEX may highlight the viability of Rituxan as a
potentially new and important treatment approach for this
difficult-to-treat patient population."
These data did not reveal any unexpected safety signals. The most
frequently reported adverse events in the study were primarily
infusion-related. Serious adverse events occurred in 7 percent of
patients receiving Rituxan and MTX compared to 10 percent in patients
receiving placebo and MTX. The incidence of serious infections was low
in both groups (2 percent in Rituxan-treated patients and 1 percent in
placebo patients). The companies are committed to monitoring long-term
safety of Rituxan in all clinical trials.
About ACR Response
ACR 20, ACR 50 and ACR 70 responses indicate a 20, 50 and 70
percent improvement in the number of swollen and tender joints,
respectively, as well as a 20, 50 and 70 percent improvement compared
with baseline in three of five disease-activity measures: patient
assessment, physician assessment, pain scale, Health Assessment
Questionnaire and the value for one acute phase reactant (erythrocyte
sedimentation rate or C-reactive protein).
About RA
RA is a debilitating autoimmune disease that affects more than two
million Americans(1) and hinders the daily activities of sufferers. RA
occurs when the immune system inappropriately attacks joint tissue,
causing painful chronic inflammation and irreversible destruction of
cartilage, tendons and bones, often resulting in disability. While RA
has traditionally been considered a T-cell-mediated disease, emerging
research suggests that other immune cells called B cells may play
multiple roles in the pathophysiology of RA, including autoantibody
production, T-cell activation and cytokine production. Common RA
symptoms include inflammation of the joints, swelling, fatigue,
stiffness and pain. Additionally, since RA is a systemic disease, it
can have effects in other tissues such as the lungs, eyes and bone
marrow.
About Rituxan
Rituxan is a therapeutic antibody that targets and selectively
depletes CD20-positive B cells without targeting stem cells or
existing plasma cells. Rituxan is currently under Priority Review by
the U.S. Food and Drug Administration for patients with active RA who
inadequately respond to anti-TNF therapy. Rituxan is also being
studied in other autoimmune diseases, including lupus, multiple
sclerosis and ANCA-associated vasculitis.
Rituxan, discovered by Biogen Idec, received FDA approval in
November 1997 for the treatment of relapsed or refractory, low-grade
or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma (NHL). It
was approved in the European Union under the trade name MabThera(R) in
June 1998. Recently, the FDA accepted a supplemental biologics license
application for Priority Review of Rituxan for front-line treatment of
intermediate grade or aggressive, CD20-positive, B-cell NHL. Genentech
and Biogen Idec co-market Rituxan in the United States, and Roche
markets MabThera in the rest of the world, except Japan, where Rituxan
is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd. Rituxan has been
used to treat more than 730,000 patients worldwide. For a copy of the
Rituxan full prescribing information, including Boxed Warning, please
call 1-800-821-8590 or visit http://www.gene.com.
Rituxan Safety Profile in non-Hodgkin's Lymphoma
In NHL patients, the majority of patients experience
infusion-related symptoms with their first Rituxan infusion. These
symptoms include but are not limited to: flu-like fever,
chills/rigors, nausea, urticaria, headache, bronchospasm, angioedema
and hypotension. These symptoms vary in severity and generally are
reversible with medical intervention. In rare instances, severe and
fatal infusion-related reactions have occurred, nearly all of which
have been associated with the first Rituxan infusion.
These events appear as manifestations of an infusion-related
complex and include hypoxia, pulmonary infiltrates, acute respiratory
distress syndrome, myocardial infarction, ventricular fibrillation,
cardiogenic shock and tumor lysis syndrome. Patients who develop
clinically significant infusion-related cardiopulmonary events should
have their Rituxan infusion discontinued and receive medical
treatment.
In rare instances, severe mucocutaneous skin reactions have
occurred that may be associated with Rituxan therapy. Many of these
reactions have been described as paraneoplastic pemphigus and are
known to be associated with various B-cell lymphomas, particularly NHL
and chronic lymphocytic leukemia. Patients who develop a severe
mucocutaneous skin reaction should have Rituxan discontinued and
receive appropriate medical treatment, including a skin biopsy to
guide therapy.
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 product
labeling, press releases and additional information about the company,
please visit www.biogenidec.com.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. As a supplier of innovative products
and services for the early detection, prevention, diagnosis and
treatment of disease, the Group contributes on a broad range of fronts
to improving people's health and quality of life. Roche is a world
leader in diagnostics, the leading supplier of medicines for cancer
and transplantation and a market leader in virology. In 2004 sales by
the Pharmaceuticals Division totaled 21.7 billion Swiss francs, while
the Diagnostics Division posted sales of 7.8 billion Swiss francs.
Roche employs roughly 65,000 people in 150 countries and has R&D
agreements and strategic alliances with numerous partners, including
majority ownership interests in Genentech and Chugai.
Biogen Idec Safe Harbor
This press release contains forward-looking statements regarding
RITUXAN as a treatment for RA. 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.
(1)American College of Rheumatology, 2005,
http://www.rheumatology.org/public/factsheets/ra.asp?aud=pat
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CONTACT: Biogen Idec
Media: Jose Juves, 617-914-6524
Investor: Oscar Velastegui, 617-679-2812
or
Roche
Media: Group Media Office, +41 61 688 8888