Roche Submits Application For FDA Approval Of ACTEMRA(R) For The Treatment Of Rheumatoid Arthritis

Roche announced the
submission of a biologics license application (BLA) to the U.S. Food and
Drug Administration (FDA) seeking approval to market ACTEMRA(R)
(tocilizumab) to reduce the signs and symptoms in adults with moderate to
severe rheumatoid arthritis (RA).


"The filing for ACTEMRA represents a significant milestone for Roche,
and brings us another step closer to making this important therapy
available to the millions of patients in the United States who suffer from
the agonizing pain and debilitating effects associated with rheumatoid
arthritis," said George Abercrombie, President and CEO, Hoffmann-La Roche
Inc.



ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting
monoclonal antibody and represents a novel mechanism of action to treat RA.
Research suggests that reducing the activity of IL-6, one of several key
cytokines involved in the inflammatory process, may reduce inflammation of
the joints and relieve certain systemic effects of RA.



The BLA submission to the FDA is based on results from five
international Phase III studies which demonstrated ACTEMRA as monotherapy
or in combination with disease modifying anti-rheumatic drugs (DMARDs) such
as methotrexate significantly reduced the signs and symptoms of rheumatoid
arthritis as measured by ACR -- as well as achieving disease activity score
(DAS) remission -- compared to DMARD therapies alone. Furthermore, patients
who had previously failed anti-tumor necrosis factor (anti-TNF) treatments
also showed significant improvement in signs and symptoms of RA after
treatment with ACTEMRA.



Roche will file a Marketing Authorization Application (MAA) for ACTEMRA
with the European Medicines Agency (EMEA) in early December.



About ACTEMRA



The clinical development program conducted by Roche includes five
clinical studies and has enrolled more than 4,000 patients in 40 countries,
including the U.S. One of these Phase III trials evaluating ACTEMRA in RA
is an ongoing two-year study and is expected to report one-year data
evaluating the effect of ACTEMRA on the inhibition of structural damage in
2008.



ACTEMRA is part of a co-development agreement with Chugai, a Japanese
company. ACTEMRA was launched in Japan by Chugai in June 2005 as a therapy
for Castleman's disease. Additional indications for RA and systemic-onset
juvenile idiopathic arthritis were also filed in Japan in April 2006 and
are currently under review.



The serious adverse events reported in ACTEMRA clinical trials were
serious infections and hypersensitivity reactions including anaphylaxis.
The most common adverse events reported in clinical studies were upper
respiratory tract infection, nasopharyngitis, headache and hypertension.
Increases in liver function tests (ALT and AST) were seen in some patients;
these increases were generally mild and reversible, with no hepatic
injuries or any observed impact on liver function.
















About Rheumatoid Arthritis



Rheumatoid arthritis is a progressive, systemic autoimmune disease
characterized by inflammation of the membrane lining in the joints. This
inflammation causes a loss of joint shape and function, resulting in pain,
stiffness and swelling, ultimately leading to irreversible joint
destruction and disability. Characteristics of RA include redness,
swelling, pain and movement limitation around joints of the hands, feet,
elbows, knees and neck that leads to loss of function. In addition, the
systemic symptoms of RA include fatigue, decreased hemoglobin and
osteoporosis and may contribute to shortening life expectancy by affecting
major organ systems. After 10 years, less than 50% of patients can continue
to work or function normally on a daily basis. RA affects more than 21
million people worldwide with approximately 2.1 million people affected in
the U.S.



About Roche



Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years in the U.S., Roche has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. An employer of choice, in 2007 Roche was named
Top Company of the Year by Med Ad News and one of the Top 20 Employers
(Science magazine). In 2006, Roche was ranked the No. 1 Company to Sell For
(Selling Power), and one of AARP's Top Companies for Older Workers, and in
2005, Roche was named one of Fortune magazine's Best Companies to Work For
in America. For additional information about the U.S. pharmaceuticals
business, visit our websites: rocheusa or
roche.us



All trademarks used or mentioned in this release are protected by law.


Roche

roche.us


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