Roche and Toyama Chemical Enter Licensing Agreement to Develop Potential Breakthrough Drug to Treat Rheumatoid Arthritis

Novel agent T-5224 may block the progressive destruction of joint and bone

NUTLEY, N.J., June 25, 2007 /PRNewswire/ -- Toyama Chemical Co., Ltd. and Roche announced today that they have entered into a licensing agreement for the worldwide research, development and commercialization of Toyama Chemical's novel oral rheumatoid arthritis agent T-5224. By inhibiting a specific inflammatory process, T-5224 has the potential to block signs and symptoms of rheumatoid arthritis as well as the progressive destruction of joint and bone. T-5224 is currently in phase I. With this partnership, Roche is further strengthening its promising portfolio and R&D pipeline in the area of rheumatoid arthritis.

"This novel oral compound complements Roche's developing portfolio of drug candidates in inflammation and rheumatoid arthritis. The agent T-5224 has the potential to inhibit a key trigger of rheumatoid arthritis and has already shown promising pharmacological efficacy and safety in early clinical studies," said Jean-Jacques Garaud, Head of Roche Pharma Development. "Our new collaboration is good news for all patients with rheumatoid arthritis as well as for our two companies. We are looking forward to collaborating with our new colleagues in Japan to develop T-5224."

"By entering into a research and development collaboration with Roche, one of the world's leading research and development companies, we are able to increase Toyama's potential for novel drug development in the anti-inflammatory field, which is a field of concentration for Toyama Chemical," said Masuji Sugata, President of Toyama Chemical.

Under the terms of the agreement, Toyama Chemical has granted Roche exclusive rights to research, develop, and sell T-5224 worldwide excluding Japan where Toyama Chemical will retain exclusive rights. The agreement also encompasses the joint research and development of back-up candidates to T-5224. Toyama Chemical will receive upfront payments and milestone payments totalling up to 370 million US dollars, based on certain development and commercial milestones. If approved for marketing, Toyama Chemical will receive royalties based on the net sales of T-5224 by Roche.

About T-5224

T-5224 is an inhibitor of the transcription factor AP-1 (Activator Protein-1) which is known to play an important role in the pathology of rheumatoid arthritis. AP-1 turns on a variety of genes in response to inflammation triggers, including many that are responsible for the proteins that are the targets of current rheumatoid arthritis products. In addition, in joint cells called osteoclasts, AP-1 stimulates the production of enzymes that are thought specifically to cause the destruction of bones and joint tissue. Therefore, by inhibiting the AP-1 process, T-5224 affects several key pathways and may prevent the progression of this disabling disease in many patients.

T-5224 was first identified as a drug candidate in rheumatoid arthritis through collaboration between Toyama Chemical Research and Professors Shunichi Shiozawa of Kobe University and Shuichi Hirono of Kitasato University. Non-clinical studies were completed through this collaboration and Phase I studies have been carried out in Japan since June of last year. Toyama Chemical is receiving, through the Contract Development Program, support from the Japan Science and Technology Agency, an independent administrative institution, for its research and development in Japan.

About rheumatoid arthritis

Rheumatoid arthritis (RA) is a progressive, systemic autoimmune disease characterized by chronic inflammation of multiple joints and fatigue as well as the possibility of osteoporosis, anaemia, and lung, skin and liver effects. This inflammation causes pain, stiffness and swelling, resulting in loss of joint function due to destruction of the bone and cartilage, often leading to progressive disability. Further, as chronic inflammation continues, there may be shortening of life expectancy as a result of effects on major organ systems. After 10 years, less than 50% of patients can continue to work or function normally on a day to day basis. RA affects more than 21 million people worldwide.

About Roche in rheumatoid arthritis

One of the most important drivers for growth at Roche over the next few years is expected to be the company'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'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.

Actemra is the result of research collaboration by Chugai and is being co-developed globally with Chugai. Additional projects creating a rich pipeline include compounds in Phase I, II and III clinical trials. Notably, ocrelizumab, a fully humanised anti-CD20 antibody, is just entering phase III development for RA.

About Toyama Chemical

Toyama Chemical specializes in research and development, and strives to contribute to the further development of global health care through new drug development. Toyama concentrates its R&D in three fields: anti-infective agents, anti-inflammatory agents, and cerebral function improvers and cardiovascular drugs. Pharmaceuticals now in the pipeline include T-3811, a synthetic antibacterial agent; T-614, an oral anti-rheumatic agent; and T-817MA, a treatment for Alzheimer's disease. The company has formed strategic partnerships with domestic and overseas pharmaceutical manufacturers as well as establishing clinical research subsidiaries in the U.S. and U.K. Validation of Toyama's success can be found in their technology exports and their royalty income which is the highest among mid-sized Japanese pharmaceutical companies. Toyama is taking an aggressive, outward-looking approach, globalizing its activities with the aim of becoming a key pharmaceutical manufacturer. Additional information about the Toyama Chemical is available on the Internet at www.toyama-chemical.co.jp/eng.

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 2006, Roche was named one of the Top 20 Employers (Science magazine), 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.

Posted: June 2007


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