Chiron Corporation (Nasdaq:CHIR) today announced that the Global Alliance for TB Drug Development (TB Alliance) has initiated Phase I clinical trials for the tuberculosis (TB) drug candidate PA-824. Chiron granted the TB Alliance exclusive worldwide rights to PA-824 and related compounds in 2002, with a commitment to make the TB technology available royalty-free in endemic countries. Clinical trials are scheduled to begin this month. The TB Alliance is a public-private partnership developing affordable, new drug regimens for TB, and PA-824 is the first TB drug from the TB Alliance pipeline to enter clinical study. After licensing PA-824 from Chiron, the TB Alliance directed and funded the drug's preclinical development. The U.S. National Institute of Allergy and Infectious Diseases of the National Institutes of Health also provided in-kind support and technical assistance. More than 40 years have elapsed since the last novel compound was introduced for the treatment of TB. "Chiron's relationship with the TB Alliance is an example of how public-private partnerships can enable drug research and development in areas of critical unmet need," said Craig Wheeler, President, Chiron Biopharmaceuticals. "Since acquiring PA-824 from Chiron, the TB Alliance has done exceptional work in moving the compound from the laboratory to the clinic. As a company committed to protecting people through innovative science, Chiron is proud to be associated with the alliance's efforts to develop new treatments for TB." Under the 2002 license agreement in which Chiron granted the TB Alliance rights to PA-824, provisions were made for possible further collaboration between Chiron and the TB Alliance at later stages of development, including a grant-back option to Chiron for manufacture and commercialization of products in developed markets. The parties have agreed that no royalties will be due under this agreement for drugs marketed in less developed economies, including impoverished countries with a high burden of tuberculosis. "Reaching this milestone greatly enhances the chances of improved TB treatment and is an important advance in the TB community's drive for a faster cure," said Dr. Maria C. Freire, President and CEO, TB Alliance. "We worked creatively and smartly with our partners, donors and contractors. The result is that an extremely promising TB compound moved from lead identification into human trials in near record time." PA-824 was first identified in 1995 by researchers at PathoGenesis Corporation, a Seattle-based biotechnology company. The drug was in preclinical development when Chiron acquired PathoGenesis in 2000. About Tuberculosis Tuberculosis (TB) is a highly contagious, airborne disease that attacks the respiratory system and is presently treated with a four-drug combination that imposes a lengthy six- to eight-month treatment course. According to a 2002 report published by the Stop TB Partnership, between 2000 and 2020 it is estimated that nearly 1 billion people will be newly infected from TB, 200 million will become sick, and 35 million will die. TB is a leading cause of death among people living with HIV/AIDS. New treatments are necessary to combat the TB epidemic because current treatment regimens utilizing approved drugs are long and cumbersome and fail to treat resistant strains. About Chiron Chiron delivers innovative and valuable products to protect human health by advancing pioneering science across the landscape of biotechnology. The company works to deliver on the limitless promise of science and make a positive difference in people's lives. For more information about Chiron, please visit www.chiron.com. This news release contains forward-looking statements, including statements regarding research and development, product development initiatives, new product indications, new product marketing, and clinical trials that involve risks and uncertainties and are subject to change. Forward-looking statements often address our expected future performance and often contain words such as "expects," "anticipates," "intends," "plans," "believes," "seeks" or "will." A discussion of the company's operations and financial condition, including factors that may affect its business and future prospects that could cause actual results and developments to differ materially from those expressed or implied by forward-looking statements, is contained in documents the company has filed with the SEC, including the Form 10-K for the year ended December 31, 2004, and the Form 10-Q for the quarter ended March 31, 2005, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including, among others, the outcome of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, litigation, and marketing effectiveness. In addition, the company may engage in business opportunities, the successful completion of which is subject to certain risks, including approval by Novartis AG, regulatory approvals, and the integration of operations. Chiron does not undertake an obligation to update the forward-looking information the company is giving today.
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