WPCR ,jj WP_TV24188566Panel (Converted)WPTVWPC2|j8{WP}01  HH  2$HH  Geneva  <Px443!#4$*$$*$ KK  Geneva  Geneva .,6  Helvetica  ca em Helvetica ca em Helvetica 4R3.5.2'3.5.2, 1996 Corel Corporation Limited,R3.5.2Created with WordPerfect 3.5.2.)#Y|jCorel WordPerfectx HH@R),, `,-^&'djjJ*PSetBPJobNTStlZStylfversrWDatSTR PtPtJJi%( d >J vJJ@ J${WP}10{WP}01"HH('  '"|j{WP}10 <<KK ..,,..,,|j Helvetica |j   Helvetica |j   Helvetica |j|jHHH<|j |j$l$ FDA Advisory Panel Recommends Approval of Synercid(R) for0 '  '0|jH<H<|j|j |j|jl$l$|jTreatment Of Severe to Life-Threatening Bacterial Infections |jH<H<|j|j |j|jl$l$|j $|jH<H<|j|j |j|jl$l$|jFebruary 19, 1998 5:30 PM EST$0|jH<H<|j|j |j|jl$l$|j 0<|jH<H<|j|j |j|jl$l$|jSynercid Represents First New Class of Antibiotics in U.S. In More than 10<H|jH<H<|j|j |j|jl$l$|jYearsHT|jH<H<|j|j |j|jl$l$|j T`|jH<H<|j|j |j|jl$l$|jCOLLEGEVILLE, Pa., and ANTONY, France, Feb. 19 /PRNewswire/ -- Rhone-Poulenc  `l|jH<H<|j|j |j|jl$l$|jRorer, a subsidiary of Rhone-Poulenc S.A. (NYSE: RP), announced today that  lx|jH<H<|j|j |j|jl$l$|jthe Anti-Infective Drugs Advisory Committee to the U.S. Food and Drug  x|jH<H<|j|j |j|jl$l$|jAdministration (FDA) has recommended approval of Synercid(R)  |jH<H<|j|j |j|jl$l$|j(quinupristin/dalfopristin) I.V. for the treatment of patients with severe  |jH<H<|j|j |j|jl$l$|jinfections associated with Gram-positive bacteria -- including certain|jH<H<|j|j |j|jl$l$|jstrains resistant to many currently available antibiotics.|jH<H<|j|j |j|jl$l$|j |jH<H<|j|j |j|jl$l$|jThe Committee recommended to the FDA that Synercid be approved for marketing|jH<H<|j|j |j|jl$l$|jfor the following indications and Gram-positive pathogens:|jH<H<|j|j |j|jl$l$|j |jH<H<|j|j |j|jl$l$|j -- Infections due to vancomycin-resistant Enterococcus faecium (VREF)|jH<H<|j|j |j|jl$l$|j -- Complicated skin and skin-structure infections|jH<H<|j|j |j|jl$l$|j -- Nosocomial (hospital-acquired) pneumonia|jH<H<|j|j |j|jl$l$|j |jH<H<|j|j |j|jl$l$|j"We are very pleased by the committee's positive recommendations and will |jH<H<|j|j |j|jl$l$|jcontinue to work closely with the FDA to gain final approval of this exciting ,|jH<H<|j|j |j|jl$l$|jnew drug," said Dr. Gary T. Shearman, Senior Vice President, Drug,8|jH<H<|j|j |j|jl$l$|jDevelopment, RPR. "Synercid is an innovative injectable antibiotic for8D|jH<H<|j|j |j|jl$l$|jhospital use that promises to play an important role in the treatment ofDP|jH<H<|j|j |j|jl$l$|jpatients with serious infectious disease, including those infected withP\|jH<H<|j|j |j|jl$l$|jbacteria resistant to many currently available antibiotics. Very often these\h|jH<H<|j|j |j|jl$l$|jpatients have undergone surgery or organ transplantation, receive kidneyht|jH<H<|j|j |j|jl$l$|jdialysis, have underlying medical conditions such as cancer or immune  t|jH<H<|j|j |j|jl$l$|jdeficiencies, or are in intensive care or burn units."!!|jH<H<|j|j |j|jl$l$|j ""|jH<H<|j|j |j|jl$l$|j Emerging Public Health Problem##|jH<H<|j|j |j|jl$l$|j $$|jH<H<|j|j |j|jl$l$|jGram-positive bacteria have emerged as the most common cause of%%|jH<H<|j|j |j|jl$l$|jhospital-acquired infections, according to a 1994 Rockefeller University&&|jH<H<|j|j |j|jl$l$|jworkshop. Worldwide experts in infectious disease and hospital epidemiology''|jH<H<|j|j |j|jl$l$|jwho participated in the workshop noted that about two million patients((|jH<H<|j|j |j|jl$l$|jcontract hospital-acquired infections each year, 50 to 60 percent of which))|jH<H<|j|j |j|jl$l$|jinvolve antibiotic-resistant bacteria. In addition, these infections add an**|jH<H<|j|j |j|jl$l$|jestimated minimum of $4.5 billion to the cost of health care in the United++|jH<H<|j|j |j|jl$l$|jStates each year.,,|jH<H<|j|j |j|jl$l$|j --|jH<H<|j|j |j|jl$l$|jFor classification purposes, bacteria are divided into two groups,..(|jH<H<|j|j |j|jl$l$|jGram-positive and Gram-negative. Infections caused by Gram-positive bacteria//(4|jH<H<|j|j |j|jl$l$|jlike Staphylococcus aureus and Enterococcus faecium have emerged as a004@|jH<H<|j|j |j|jl$l$|jsignificant public health threat because of their propensity to develop11@L|jH<H<|j|j |j|jl$l$|jresistance to many commonly used antibiotics.22LX|jH<H<|j|j |j|jl$l$|j 33Xd|jH<H<|j|j |j|jl$l$|jStaphylococcus epidermidis is a type of bacteria often found on the skin that44dp|jH<H<|j|j |j|jl$l$|jhas become a common cause of hospital infections, including infections of55p||jH<H<|j|j |j|jl$l$|jpostsurgical wounds. It is also a major cause of life-threatening bloodstreamJ66| ||66 HJ|jH<H< l$l$|jinfections, particularly in immunocompromised patients.7|jH<H<|j|j |j|jl$l$|j 8H< Cl DhCStaphylococcus aureus is a type of bacteria responsible for severe andH< Cl DhCpotentially life-threatening infections such as bone and joint infections,H< Cl DhChospital-acquired pneumonia, skin and other soft-tissue infections andH< Cl DhCbacteremia (bloodstream infections).H< Cl DhC H< Cl DhCEnterococcus faecium, a member of the family of bacteria known asH< Cl DhCenterococci, is a cause of bacteremia, infections of the urinary tract andH< Cl DhCintra-abdominal infections, all considered life-threatening. Some E. faeciumH< Cl DhCstrains have become resistant to virtually all available antibioticsH< Cl DhCincluding vancomycin, often considered by the medical community as the lastH< Cl DhCdefense for hospital-acquired infections.H< Cl DhC H< Cl DhC Clinical StudiesH< Cl DhC H< Cl DhCSynercid was studied worldwide in more than 2,000 patients in fiveH< Cl DhCcomparative clinical trials and in an FDA-sanctioned emergency-use programH< Cl DhCfor patients for whom there were no alternative therapies. In the comparativeH< Cl DhCtrials, Synercid was tested against other antibacterial agents, includingH< Cl DhCvancomycin, the antibiotic recognized by the medical community as theH< Cl DhCstandard of therapy for infections caused by the Staphylococcus aureus andH< Cl DhCStaphylococcus epidermidis strains resistant to the antibiotic methicillin.H< Cl DhC H< Cl DhC"Synercid is a significant addition to the arsenal of anti-infectiveH< Cl DhCweapons," said Robert Moellering, M.D., professor of medicine, HarvardH< Cl DhCUniversity, chairman of the Department of Medicine, Beth Israel DeaconessH< Cl DhCMedical Center in Boston and a lead investigator for Synercid clinicalH< Cl DhCtrials. "Synercid will help doctors fight the rising tide of Gram-positiveH< Cl DhCbacterial resistance to currently available treatments."H< Cl DhC H< Cl DhC BackgroundH< Cl DhC H< Cl DhCSynercid is an injectable streptogramin -- the first new class of antibioticsH< Cl DhCto be reviewed for marketing clearance in the United States in more than 10H< Cl DhCyears. Synercid is composed of two distinct compounds, quinupristin andH< Cl DhCdalfopristin. These two compounds work synergistically at up to 16 times theH< Cl DhCpower of either agent alone to kill susceptible bacteria through aH< Cl DhCtwo-pronged attack on protein synthesis in bacterial cells. Without theH< Cl DhCability to manufacture new proteins, the bacterial cells die.H< Cl DhC H< Cl DhCDuring clinical trials, Synercid was generally well-tolerated. The mostH< Cl DhCcommon local reactions were inflammation, pain, fluid retention (edema), andH< Cl DhCinfusion-site reaction. The most common systemic reactions were muscle andH< Cl DhCjoint pain, nausea, diarrhea, vomiting, and rash. In the comparative studies,H< Cl DhC10.7 percent of patients discontinued therapy because of local reactions andH< Cl DhC6.1 percent because of systemic reactions. Among patients in theH< Cl DhCemergency-use program, 5.4 percent discontinued therapy due to systemicH< Cl DhCreactions and 0.7 percent due to local reactions.H< Cl DhC H< Cl DhCRhone-Poulenc S.A. (NYSE: RP) is a leading life sciences company, growingH< Cl DhCthrough innovations in human, plant and animal health and through itsH< Cl DhCspecialty chemicals subsidiary, Rhodia. With sales in 1997 of FF90 billionH< Cl DhC(US$15 billion), the company employs 68,400 people in 160 countriesH< Cl DhCworldwide.H< Cl DhC H< Cl DhCThe Rhone-Poulenc Pharmaceutical Sector is composed of: Rhone-Poulenc Rorer,H< Cl DhCa global pharmaceutical company, Pasteur Merieux Connaught (human vaccines)H< Cl DhCand Centeon (a joint venture focused on plasma proteins). SOURCEH< Cl DhCRhone-Poulenc Rorer Inc.H< Cl DhC H< Cl DhC PR Newswire. All rights reserved.H< Cl DhC H< Cl DhCCompany Profile - From E*TRADE:RPH< Cl DhCStock Charts - From Quote.Com:RPH< Cl DhCSEC Filings - From EDGAR Online:RPH< Cl DhCCompany Capsule - From Hoovers Online:RP