SRI International and Taiho Pharmaceutical Co., Ltd. to conduct development on promising new breast cancer drugs

Menlo Park, Calif. (June 08, 1999) -- SRI International, a leading research institute based in Silicon Valley, and Taiho Pharmaceutical Co., Ltd., a leading oncology company in Japan, today announced a series of agreements to begin development on a promising new approach to the treatment of breast cancer. As part of the agreement, Taiho has licensed from SRI worldwide rights for the development and marketing of SR 16234 (TAS-108) in the oncology field. SRI will receive up front and milestone payments, plus research and development funding and royalties on approved products.
 
SRI's Pharmaceutical Discovery Division, which combines chemical, biological and pharmacological expertise, will focus on two main issues. To ensure that the compounds meet manufacturing cost targets, SRI will improve the chemical synthetic processes. In addition, SRI will study the biological mechanism of action of these novel compounds against tamoxifen-resistant breast cancer. This research will be completed by January 2000. Preclinical development will in turn be spearheaded by SRI's Biopharmaceutical Development Division and is scheduled for completion within 15 months.
 
"SRI and Taiho's initial collaborative research indicates that these compounds have tremendous potential to inhibit the growth of breast cancers that have proven resistant to tamoxifen treatment," said Michael Tracy, D. Phil., vice president of SRI's Pharmaceutical Discovery Division. "Our task now is to ensure that these promising drugs can be manufactured economically so that they can benefit a large percentage of the population.
 
"SRI International has the capabilities and experience to conduct an integrated drug development program for Taiho. Our program will consist of everything from pharmaceutical dosage design to clinical trial manufacturing and pharmacology and safety studies," said Pieter C. Bax, Ph.D., M.B.A, vice president of SRI's Biopharmaceutical Development Division. "In addition, SRI can provide the necessary regulatory guidance to Taiho as the company files its investigational new drug (IND) package in the United States, Europe and Japan.
 
SRI and Taiho have been collaborating since October 1996 on the development and evaluation of novel endocrine approaches for the treatment of tamoxifen-resistant breast cancers. A series of synthetic drug leads were evaluated in vitro and in vivo and SR 16234 (TAS-108) was identified as a lead candidate for further preclinical and clinical development. As part of Taiho's worldwide development strategy, upon completion of the preclinical development, Taiho intends to file its first IND application in the United States with subsequent human trials. Taiho plans to market the drug both as a treatment for breast cancers that have proven resistant to tamoxifen, and as a frontline strategy for breast cancer treatment.
 
"Taiho has been focused on identifying new cancer treatments for patients," said Yukio Kobayashi, president of Taiho Pharmaceutical Co., Ltd. "We intend to market this very promising new drug on a worldwide basis if it proves safe and effective in patients."
 
Taiho Pharmaceutical Co., Ltd. is a member of the Otsuka Group of companies, based in Tokyo, Japan. The company had over $742 million in sales in 1998 and employs nearly 2,200 people. Taiho's lead product UFT is currently the number one anti-cancer agent in Japan. The company also has several novel and proprietary anti-cancer compounds in worldwide clinical development.
 
Silicon Valley-based SRI International is one of the world's largest independent research, technology development and consulting organizations. Founded in 1946 as the Stanford Research Institute, SRI has been meeting the strategic needs of global markets for more than 50 years. As part of its strategy to bring its technologies to the marketplace, SRI licenses its technologies, forms strategic partnerships and creates spin-off companies.