Chiron Concludes Phase III Program for MENJUGATE Meningococcal C Vaccine in United States.EMERYVILLE, Calif. -- Company to focus efforts on further development of meningococcal ACWY conjugated conjugated adj. Conjugate. estrogens, conjugated Warning - Hazardous drug! C.E.S. vaccine Chiron Corporation Chiron Corporation was a multinational biotechnology firm based in Emeryville, California that was acquired by Novartis International AG on April 20 2006. It had offices and facilities in eighteen countries on five continents. (Nasdaq:CHIR CHIR Chiricahua National Monument (US National Park Service) ) today announced that it has successfully concluded its Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial for MENJUGATE(R) meningococcal C vaccine in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and will not be filing a Biologics License Application (BLA BLA abbr. Bachelor of Liberal Arts ) for the vaccine. The now-completed Phase III trial in the United States expanded the safety and immunogenicity immunogenicity /im·mu·no·ge·nic·i·ty/ (-je-nis´it-e) the property enabling a substance to provoke an immune response, or the degree to which a substance possesses this property. database for MENJUGATE, a conjugated vaccine. "Given the changing landscape for meningococcal vaccines in the United States, we believe that our resources are better deployed by focusing on advancing our quadravalent vaccine candidate for serogroups A, C, W and Y," said John Lambert, president, Chiron Vaccines. "We have learned a great deal from the Phase III study of MENJUGATE, and we will apply that experience to move our ACWY vaccine candidate through development." Chiron's meningococcal ACWY vaccine is currently in Phase II. The company initiated a Phase II study in infants this year and plans to initiate a Phase III program for the vaccine in 2005. About Chiron Chiron delivers innovative and valuable products to protect human health by advancing pioneering science across the landscape of biotechnology. We work to deliver on the limitless promise of science and make a positive difference in people's lives. For more information, please visit www.chiron.com. This news release contains forward-looking statements, including statements regarding development of Chiron's meningococcal ACWY vaccine, clinical timelines, regulatory approvals, market growth and size, and new product marketing, that involve risks and uncertainties and are subject to change. A full discussion of the company's operations and financial condition, including factors that may affect its business and future prospects, is contained in documents the company has filed with the SEC, including the form 10-Q Form 10-Q See 10-Q. for the quarter ended September 30, 2004, and the form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2003, 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 the outcome of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, stock-price and interest-rate volatility, and marketing effectiveness. In particular, there can be no assurance that Chiron will increase sales of existing products, successfully develop and receive approval to market new products, or achieve market acceptance for such new products. There can be no assurance that Chiron's out-licensing activities will generate significant revenue, nor that its in-licensing activities will fully protect it from claims of infringement by third parties. In addition, the company may engage in business opportunities, the successful completion of which are subject to certain risks, including shareholder and regulatory approvals and the integration of operations. We do not undertake an obligation to update the forward-looking information we are giving today. Note: MENJUGATE is a trademark of Chiron Corporation. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion