What's New

June 25, 2007; Toyama Chemical Co., Ltd. (Tokyo/ President: Masuji Sugata) (“Toyama Chemical”) and F. Hoffmann-La Roche (Basel/ Chairman and CEO: Dr. Franz B. Humer) (“Roche”) announced today that they have entered into a license agreement for the worldwide research, development and commercialization of Toyama Chemical's novel anti-rheumatoid arthritis agent, T-5224.

Overview of the agreement

1. Toyama Chemical has granted Roche exclusive rights to research, develop, and sell T-5224 worldwide excluding Japan
2. Toyama Chemical has exclusive rights to research, develop and sell T-5224 in Japan
3. Toyama Chemical will receive upfront payments and milestone payments totaling up to US$370 million, based on certain development and commercial milestones
4. Toyama Chemical will receive royalties based on the net sales of T-5224 by Roche

About T-5224

Toyama Chemical has been researching the transcription factor AP-1* (Activator Protein 1), known to play an important role in the pathology of rheumatoid arthritis, in a research collaboration with Professor Shunichi Shiozawa of Kobe University and Professor Shuichi Hirono of Kitasato University. As a result, “T-5224” was identified as a compound with the potential of becoming a fundamental treatment for rheumatoid arthritis. Thereafter, the necessary non-clinical studies were completed, and Phase 1 studies have been carried out from June last year in Japan. Toyama Chemical is receiving, through the Contract Development Program, funding of JPY 2.5 Billion from the Japan Science and Technology Agency, an independent administrative institution, for its research and development in Japan.

In the past, many anti-rheumatoid arthritis agents had been developed, mainly to ameliorate abnormal immune responses, and recently antibodies which inhibit inflammatory proteins are being developed. However, complete inhibition of the progression of joint and bone destruction, which is the largest problem for rheumatoid arthritis, has not been achieved. Under such circumstances, as T-5224 inhibits AP-1 from binding to DNA, it can represses the production of inflammatory proteins and enzymes related to bone destruction, and subsequently stop inflammation and joint and bone destruction. It is thought to have the potential of becoming a novel treatment for rheumatoid arthritis.

Roche, whom entered into the license agreement with Toyama Chemical, has experience in developing anti-rheumatoid arthritis agents (antibodies), and has high regards for T-5224's possibility on becoming a fundamental treatment of rheumatoid arthritis, based on the pharmacological efficacy and safety of this small molecule compound.

At entering the agreement, Dr. Jean-Jacques Garaud, Head of Roche Pharma Development stated "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. 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."

And, Masuji Sugata (Toyama Chemical, President) stated that "By entering into a 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".

Toyama Chemical specializes in research and development, and strives to "contribute to the further development of global health care through new drug development".

*AP-1 (Activator Protein 1)
Proteins in the body are produced from the translation of DNA, and the process begins when the transcription factor binds with the DNA translation initiation sites. AP-1 is one of many transcription factors, and is involved in the production of inflammatory proteins and enzymes related to joint and bone destruction. One of many pathologies of rheumatoid arthritis is, the excess AP-1 produces vast amounts of inflammatory proteins and enzymes related to joint and bone destruction, known to cause progression of inflammation and joint and bone destruction.