Investor Update
Basel, 20 October 2008
Variety of studies on Roche’s Rheumatoid Arthritis portfolio to be presented at the American College of Rheumatology Annual Scientific Meeting
Overview of studies to be presented, San Francisco October 24 – 29
Roche today announced that a total of 15 abstracts involving its investigational rheumatoid arthritis (RA) treatment Actemra (tocilizumab), a novel treatment targeting interleukin-6 (IL-6) receptors, in patients with moderately to severely active RA and 10 abstracts featuring MabThera (rituximab), the first selective B cell therapy in RA, have been accepted for presentation at the 2008 American College of Rheumatology (ACR) Annual Scientific Meeting, which will take place October 24-29 in San Francisco.
– Phase III data highlight the benefits of Actemra in treating rheumatoid arthritis –
Platform Presentations/Poster Sessions
October 27, 2:45 pm - 3:00 pm PDT, Room 307 [Oral Presentation during the RA Treatment: Biologic Efficacy RCT's session], “Tocilizumab Rapidly and Significantly Improves Outcomes in Patients with Rheumatoid Arthritis Who Have Inadequate Response to TNF Antagonists” (Presenter: Paul Emery, M.D.)
October 27, 3:00 pm - 3:15 pm PDT, Room 307 [Oral Presentation during the RA Treatment: Biologic Efficacy RCT's session], “The AMBITION Study: Superiority of Tocilizumab vs. Methotrexate Monotherapy in Patients with Rheumatoid Arthritis” (Presenter: Graeme Jones, M.D.)
October 28, 3:15 pm - 3:30 pm PDT, Room 307 [Oral Presentation during the ACR Business Meeting and Late-Breaking Abstracts session], “Tocilizumab Inhibits Structural Joint Damage in RA Patients with an Inadequate Response to Methotrexate: The LITHE Study” (Presenter: Joel M. Kremer, M.D.)
There are 12 additional posters and abstracts highlighting results from the extensive multi-national Actemra clinical development program, which included more than 4,000 patients in 41 countries, including the U.S.
– New data show MabThera is effective and well tolerated over the long-term in rheumatoid arthritis –
Highlights from Poster Sessions
October 26, 09.00-11.00 am PDT, Hall A [Poster presentation 367] “Efficacy and Safety of Repeat Treatment Courses of Rituximab (RTX) in RA Patients (pts) with Inadequate Response (IR) to Tumour Necrosis Factor (TNF) Inhibitors: Long-term Experience from the REFLEX study” (Presenter: Edward Keystone, M.D.)
October 26, 09.00-11.00 am PDT, Hall A [Poster presentation 368] “Continued Inhibition Of Structural Damage In Rheumatoid Arthritis Patients Treated With Rituximab At 2 Years: REFLEX Study” (Presenter: Stanley Cohen, M.D.)
October 26, 09.00-11.00 am PDT, Hall A [Poster presentation 361] “Long-Term Safety of Rituximab: 6-year Follow-up of the RA Clinical Trials and Re-treatment Population” (Presenter: Ronald van Vollenhoven, M.D.)
October 28, 09.00-11.00 am PDT, Hall A [Poster presentation 393] “Safety Of Other Biologic Therapies Following Rituximab Treatment In RA Patients” (Presenter: Mark Genovese, M.D.)
Rheumatoid Arthritis - A High Unmet Medical Need
Rheumatoid arthritis is thought to affect over 21 million people worldwide. It is a progressive autoimmune disease characterized by inflammation of the membrane lining in the joints throughout the body. This inflammation causes distortion of the joint and impaired function accompanied by pain, stiffness and swelling, and ultimately leads to irreversible joint destruction and disability. In addition, the systemic symptoms of RA include fatigue, anaemia, 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.
About Actemra (tocilizumab)
Actemra is the result of research collaboration by Chugai and is being co-developed globally with Chugai. Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development program of five Phase III trials was designed to evaluate clinical findings of Actemra. The five studies have reported meeting their primary endpoints. In Japan, Actemra was launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2008, additional indications for rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan.
Actemra is generally well tolerated. The overall safety profile of Actemra is consistent across all global clinical studies. The serious adverse reactions reported in Actemra clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis. The most common adverse reactions reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, hypertension and increased ALT. Increases in liver enzymes (ALT and AST) were seen in patients; these increases were generally mild and reversible, with no evidence of hepatic injuries. Laboratory changes, including increases in lipids (total cholesterol, LDL, HDL, triglycerides) and decreases in neutrophils and platelets, were seen in patients without association with clinical outcomes. Treatments that suppress the immune system, such as Actemra, may cause an increase in the risk of malignancies.
About MabThera (rituximab)
MabThera selectively targets B cells and represents a new highly effective therapeutic approach for RA in addition to existing treatments such as disease-modifying anti-rheumatic drugs (DMARDs) and tumour necrosis factor (TNF) inhibitors.
B cells are known to play a key role in the inflammation associated with RA. As the first and only selective B cell therapy available for the treatment of RA, MabThera represents a proven and truly different alternative for patients who have inadequate response or are not able to tolerate TNF inhibitor therapy. MabThera is the only RA treatment that has demonstrated the ability to preserve joint structure in this patient group and offers an unprecedented duration of response of at least six months with each course. Each course of MabThera also provides the opportunity of sustained or improved relief for patients from the signs and symptoms of their disease.
MabThera is marketed in the US by Genentech and Biogen Idec under the brand name Rituxan®.
For more information about MabThera please visit www.mabthera-ra.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 the world’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’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.
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