Phase III Study Shows Rituxan(R) Significantly Improves Symptoms in Patients With Rheumatoid Arthritis Who Inadequately Responded to Anti-TNF Therapies

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Phase III Study Shows Rituxan® Significantly Improves Symptoms in

Patients With Rheumatoid Arthritis Who Inadequately Responded to

Anti-TNF Therapies

Wednesday April 6, 1:30 am ET

- Third Randomized Trial to Evaluate Efficacy and Safety of Rituxan in

RA

SOUTH SAN FRANCISCO, Calif., CAMBRIDGE, Mass. and BASEL, Switzerland,

April 6 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE: DNA - News),

Biogen Idec (Nasdaq: BIIB - News) and Roche (SWX Zurich) announced

today that a Phase III clinical study of Rituxan® (Rituximab) met its

primary endpoint of a greater proportion of Rituxan-treated patients

achieving an American College of Rheumatology (ACR) 20 response at week

24, compared to placebo. The study included patients with active

rheumatoid arthritis (RA) who have had an inadequate response or were

intolerant to prior treatment with one or more anti-TNF therapies.

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In this study, known as REFLEX (Randomized Evaluation of Long-term

Efficacy of Rituximab in RA), patients who received a single treatment

course of two infusions of Rituxan with a stable dose of methotrexate

(MTX) displayed a statistically significant improvement in symptoms

compared to patients who received placebo and MTX. Further analyses of

the data are ongoing and will be submitted for presentation at an

upcoming medical meeting.

A preliminary analysis of the data did not reveal any unexpected safety

signals. The most common side effects in the Rituxan arm included

headache, upper respiratory tract infection and nasopharyngitis. The

reported rate of serious adverse events was comparable across the two

treatment arms.

" These results continue to support the potential of Rituxan as a new

therapeutic option for RA, " said Burt Adelman, M.D., executive vice

president, development, Biogen Idec. " We look forward to sharing the

REFLEX data in our discussions with the FDA. "

" These are the first Phase III Rituxan data to demonstrate clinical

improvement in this difficult-to-treat RA patient population. The

findings add to the growing body of evidence that selectively targeting

B cells may provide an important new treatment approach for this

debilitating disease, " said Hal Barron, M.D., Genentech's senior vice

president, development and chief medical officer. " While we are

encouraged that the preliminary safety results are similar to previous

studies, we recognize the importance of monitoring long-term safety in

RA patients treated with Rituxan. "

These new Phase III data follow recent positive preliminary findings

from a Phase IIb study that evaluated the efficacy and safety of

Rituxan in moderate-to-severe RA patients who failed prior treatment

with at least one disease-modifying anti-rheumatic drug (DMARD).

About the Study

A total of 520 patients from the United States, Canada and Europe were

randomized to receive either Rituxan (1000 mg i.v. on days one and 15)

or placebo in this multi-center, double-blind, placebo-controlled

study. All patients received a stable dose of MTX and a two-week course

of corticosteroids.

ACR 20 indicates a 20 percent improvement in the number of swollen and

tender joints, as well as a 20 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 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

peripheral CD20 positive B cells without targeting stem cells or

existing plasma cells. B cells may play multiple roles in the

pathophysiology of RA. Rituxan is also being investigated in other

autoimmune diseases including lupus, multiple sclerosis and ANCA

associated vasculitis.

Rituxan received initial 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 also was approved in

the European Union (EU) under the trade name MabThera® in June 1998.

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 with Zenyaku Kogyo Co. Ltd. Rituxan has been

used to treat more than 380,000 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 NHL

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 Genentech

Genentech is a leading biotechnology company that discovers, develops,

manufactures and commercializes biotherapeutics for significant unmet

medical needs. A considerable number of the currently approved

biotechnology products originated from or are based on Genentech

science. Genentech manufactures and commercializes multiple

biotechnology products directly in the United States and licenses

several additional products to other companies. The company has

headquarters in South San Francisco, California and is traded on the

New York Stock Exchange under the symbol DNA. For additional

information about the company, please visit http://www.gene.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 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.