CHIR Chiron (MM)

Chiron Corporation (Nasdaq:CHIR) today announced that the European Commission has granted marketing approval for CUBICIN(R) (daptomycin), a first-in-class IV antibiotic. The marketing approval was granted in the 25 member states of the European Union, Iceland, Liechtenstein and Norway. Under the approval, CUBICIN is indicated for the treatment of complicated skin and soft-tissue infections (cSSTI) caused by Gram-positive bacteria. CUBICIN is expected to become available in the United Kingdom and the Netherlands within the next few weeks, followed by additional European countries, in accordance with local legal regulations. Gram-positive bacteria are a major cause of problematic infections in many healthcare facilities and institutions. Of particular concern are methicillin-resistant Staphylococcus aureus (MRSA), glycopeptide-intermediate S. aureus (GISA) and glycopeptide-resistant enterococci (VRE or GRE), particularly E. faecium, which are driving the need for new antibacterial agents. The novel mechanism of action of CUBICIN means that it is unaffected by the high-level cross-resistance that occurs with many other antibiotic classes.(1),(2) The use of CUBICIN is supported by clinical data from two pivotal Phase 3 clinical trials conducted by Cubist that examined the safety and efficacy of CUBICIN in the treatment of cSSTI. These trials demonstrated that CUBICIN was as effective as standard therapy in this indication.(3) "The launch of CUBICIN in Europe provides an important new alternative in the treatment of serious skin infections, which are increasingly resistant to standard drug therapies," said Craig Wheeler, president of Chiron BioPharmaceuticals. "Chiron's work to make CUBICIN available in Europe is a reflection of our continuing commitment to protecting people through innovative science." Mike Bonney, President and CEO of Cubist, said, "European market approval helps to validate the potential of CUBICIN, our first-in-class lipopeptide antibiotic, worldwide. The news today is also a reflection of our solid working relationship with Chiron." Chiron licensed development and commercialization rights to CUBICIN in the European Union from Cubist, which launched CUBICIN in the United States in November 2003. About CUBICIN(R) (Daptomycin Powder for Solution for Infusion) CUBICIN is the first of a new class of antibiotics called cyclic lipopeptides. Its mechanism of action, distinct from any other antibiotic, involves binding to the cell membrane of Gram-positive bacteria, causing depolarization and leading to inhibition of protein, DNA and RNA synthesis. This results in bacterial cell death. Two randomized, controlled clinical trials studied the efficacy and safety of 4mg/kg once daily CUBICIN in complicated skin and soft-tissue infections in adults compared to vancomycin or semi-synthetic penicillins. In both of these studies, CUBICIN was shown to be as effective as the comparator agents. CUBICIN has been shown to be effective clinically in complicated skin and soft-tissue infections caused by the following organisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae subsp equisimilis and Streptococcus pyogenes. For subjects who received CUBICIN in clinical trials, the adverse reactions most frequently reported were headache, nausea, vomiting, diarrhea, muscle pain, fungal infections, rash, infusion site reaction, increased Creatine phosphokinase (CPK) and abnormal liver enzymes Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Alkaline phosphatase (ALP). CUBICIN was approved for the treatment of complicated skin and skin-structure infections by the U.S. Food and Drug Administration in September 2003. CUBICIN is also approved for use in Israel and Argentina. -0- *T References (1) Raja A et al. Nat Rev Drug Discov 2003; 2: 943-44. (2) Silverman JA et al. Antimocrob Agents Chemother 2001; 45: 1799-1802. (3) Arbeti RD et al. Clin Infect Dis 2004; 38: 1673-81. *T 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. Chiron Forward-Looking Statement This news release contains forward-looking statements, including statements regarding local European member state regulatory approval of CUBICIN, expected timing for such approvals and sales and marketing of CUBICIN, 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 September 30, 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 the outcome of clinical trials, regulatory review and approvals, competition, manufacturing capabilities, intellectual property protections and defenses, and marketing effectiveness. In particular, there can be no assurance that Chiron will receive approval to market or begin marketing CUBICIN in any European member states in the first quarter of 2006 or achieve market acceptance for CUBICIN. Chiron does not undertake an obligation to update the forward-looking information the company is giving today. NOTE: Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals Inc.; HepeX-B is a trademark of XTL Biopharmaceuticals Ltd.