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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 21 November 2007\line \line {\b Roche 
Submits Application for FDA Approval of Actemra for the Treatment of Rheumatoid Arthritis} \line Actemra 
is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody seeking approval 
to treat rheumatoid arthritis \line \line Roche announced today the submission of 
a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval 
for Actemra (tocilizumab) to reduce the signs and symptoms in adults with moderate to severe rheumatoid 
arthritis (RA). \line  \line \u8220?The filing for Actemra in the U.S. is an important 
milestone for Roche, and brings us another step closer to making this therapy available to the millions 
of patients in the United States who suffer from the pain and debilitating effects of rheumatoid arthritis,\u8221? 
said William M. Burns, CEO of the Pharmaceuticals Division at Roche. \line \line 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.\line \line The BLA submission to the FDA 
is based on results from five international Phase III studies \line 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 and disease 
activity score (DAS) remission rates, compared with 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.\line \line 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. and Europe. 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. \line \line Roche will file 
a Marketing Authorisation Application (MAA) for the product with the European Medicines Agency (EMEA) 
in early December. \line \line {\b About Actemra} \line Actemra 
is the result of research collaboration by Chugai and is being co-developed globally with Chugai. Actemra 
is the first humanised interleukin-6 (IL-6) receptor inhibiting monoclonal antibody and represents a 
novel mechanism of action to treat RA, a disease with a high unmet medical need. The overall safety 
profile observed in the global studies of Actemra is consistent and Actemra is generally well tolerated. 
The serious adverse events reported in Actemra global clinical studies included serious infections and 
hypersensitivity reactions including a few cases of anaphylaxis. The most common adverse events reported 
in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, 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.\line \line Roche 
and Chugai are collaborating on a phase III clinical development programme in RA running outside Japan, 
with more than 4000 patients enrolled in 40 countries including several European countries and the USA. 
In Japan, Chugai launched Actemra in June 2005 as a therapy for Castleman's disease and in April 2006 
filed for the additional indications of rheumatoid arthritis and systemic-onset juvenile idiopathic 
arthritis. \line \line {\b About Roche in rheumatoid arthritis} \line One 
of the most important drivers for growth at Roche over the next few years is expected to be the company\u8217?s 
emerging franchise in autoimmune diseases with rheumatoid arthritis as the first indication. Following 
the launch of MabThera (rituximab) there are a number of projects in development, potentially allowing 
Roche to build on further opportunities. MabThera is the first and only selective B-cell therapy for 
RA, providing a fundamentally different treatment approach by targeting B cells, one of the key players 
in the pathogenesis of RA. Actemra is Roche\u8217?s second novel medicine and is a humanised monoclonal antibody 
to the interleukin-6 (IL-6) receptor, inhibiting the activity of IL-6 , a protein that plays a major 
role in the RA inflammation process. Additional projects creating a rich pipeline include compounds 
in Phase I, II and III clinical trials. Notably, ocrelizumab, a humanised anti-CD20 antibody, has entered 
phase III development for RA.\line \line {\b About Roche} \line Headquartered 
in Basel, Switzerland, Roche is one of the world\u8217?s leading research-focused healthcare groups in the 
fields of pharmaceuticals and diagnostics. As the world\u8217?s biggest biotech company and an innovator of 
products and services for the early detection, prevention, diagnosis and treatment of diseases, the 
Group contributes on a broad range of fronts to improving people\u8217?s health and quality of life. Roche 
is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader 
in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic 
disorders and diseases of the central nervous system. In 2006 sales by the Pharmaceuticals Division 
totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. 
Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership 
interests in Genentech and Chugai, and invests approximately 7 billion Swiss francs a year in R&D. 
Worldwide, the Group employs about 75,000 people. Additional information is available on the Internet 
at www.roche.com (http://www.roche.com).\line \line {\b About Chugai} \line Chugai 
Pharmaceutical, specializes in prescription pharmaceuticals and based in Tokyo, is Japan\u8217?s leading research-based 
pharmaceutical companies with strengths in biotechnology products.\line Since the start of 
the strategic alliance with Roche in October 2002, Chugai is actively involved in prescription pharmaceutical 
R&D activities in Japan and abroad as an important member of the Roche Group. Specifically, Chugai 
is working to develop innovative products with global applications, focusing on the disease areas of 
oncology, renal disease, and bone and joint.\line In Japan, Chugai\u8217?s research facilities in 
Gotemba and Kamakura are collaborating to develop new pharmaceuticals and Ukima is conducting research 
for technology development for industrial production. Overseas, Chugai Pharma USA and Chugai Pharma 
Europe are engaged in clinical development activities in the United States and Europe. Additional information 
is available on the Internet at www.chugai-pharm.co.jp (http://www.chugai-pharm.co.jp/english/index.html).\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are protected by law.\par}\line \line {\b Further 
information} \line - Roche & Autoimmune diseases \line \par}
{\pard \par}
{\pard\sb180\f1\fs22 {\b F. Hoffmann-La Roche Ltd}\line 4070 Basel\line Switzerland \par}
{\pard\sb180\f1\fs22 Corporate Communications\line Roche Group Media Relations \par}
{\pard\sb180\f1\fs22 Tel. +41 61 688 88 88\line Fax +41 61 688 27 75\line www.roche.com \par}
}