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| |  FDA Committee Recommends Approval Of New Antibiotic, Zyvox (Linezolid) GAITHERSBURG, MD -- March 27, 2000 -- The U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee recommended approval of Zyvox(TM) (pronounced ZY-vox) (linezolid injection, tablets, and oral suspension Pharmacia & Upjohn) for the treatment of patients with hospital-acquired pneumonia, including those cases caused by methicillin- resistant Staphylococcus aureus (MRSA); community-acquired pneumonia; and complicated and uncomplicated skin and skin structure infections, including cases with concurrent bacteremia (bloodstream infections). The Committee also recommended approval of Zyvox for the treatment of infections caused by vancomycin-resistant Enterococcus (VRE). Zyvox is the first antibiotic in a completely new class -- the oxazolidinones -- in 35 years. "We are very pleased with the Advisory Committee's recommendation for the approval of Zyvox," said Goran Ando, M.D., Executive Vice President, Research & Development, Pharmacia & Upjohn. "We will continue to work with the FDA to seek final approval of this novel antibiotic." Clinical studies involving more than 4,000 patients have shown that Zyvox is effective against medically significant Gram-positive bacteria, including those resistant to other antibiotics. Gram-positive bacteria include staphylococci, streptococci, pneumococci and enterococci -- all primary causes of the infections for which Zyvox is being developed. Zyvox will have IV and oral formulations that are both 100 percent bioavailable. "With Zyvox, physicians will be able to switch patients from IV to oral therapy without dose adjustment at the appropriate time," said Dennis L. Stevens, MD, PhD, Infectious Disease Section Chief, Boise Veterans Affairs Medical Center. "The Committee's recommendation is an important step and will provide physicians a much-needed alternative for the treatment of Gram-positive infections." Zyvox comes from a completely new class of antibiotics that disrupts the initiation of bacterial protein synthesis at an earlier stage of the cycle than other antibiotics. The bacteria are then unable to manufacture proteins and are unable to reproduce. Based on clinical studies involving more than 4,000 patients, Zyvox is generally well tolerated. The most common drug-related medical events reported for patients receiving Zyvox in clinical trials were headache, nausea and diarrhea. These events were usually mild to moderate in intensity and each event occurred in less than five percent of patients. Gram-positive pathogens are currently defined by many in the public health and infectious disease communities as one of the greatest challenges in hospital infections. About two million people in the United States and more than nine million people globally contract hospital-acquired infections each year. Zyvox is being developed for global use. In November 1999, a market authorization application was submitted to the UK Medicines Control Agency as a rapporteur country for the European Community. Applications are also being submitted throughout Asia and Latin America. Pharmacia & Upjohn is a global innovation-driven pharmaceutical and health care company. Pharmacia & Upjohn's products, services and employees demonstrate its commitment to improve wellness and quality of life for people around the world. Related Link: Pharmacia & Upjohn.
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