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Rhone-Poulenc Rorer Launches New Anti-Infective ZAGAM(R) in U.S.

COLLEGEVILLE, Pa., May 19 /PRNewswire/ -- Rhone-Poulenc Rorer Inc. (NYSE: RPR) announced today that ZAGAM(R) (sparfloxacin) tablets, a once-daily oral antibiotic for the treatment of community-acquired pneumonia (CAP) and acute bacterial exacerbations of chronic bronchitis (ABECB), is now available by prescription nationwide. ZAGAM recently received clearance for marketing from the U.S. Food and Drug Administration and is available in a RespiPac(TM) -- an easy-to-use daily-dosing package designed to promote patient compliance by providing the initial dose and full course of therapy.

"RPR is committed to developing anti-infectives that are designed to meet specific patient needs where resistance to current therapies is a growing problem," said Stephen P. Connelly, Senior Vice President and General Manager, The Americas, RPR. "ZAGAM is a new quinolone in a promising pipeline of antibiotics being developed by RPR that may help address some of these clinical challenges."

Recent surveillance of in vitro data published in the medical journal "Antimicrobial Agents and Chemotherapy" showed that the overall rate of S. pneumoniae resistance to penicilins, cephalosporins, macrolides and older fluoroquinolones collectively is 23.6 percent(A). "The rapid increase of resistance to once-effective antibiotics poses a significant barrier to the treatment of common respiratory infections," said George Bensch, M.D., director of allergy and immunology at the San Joaquin Teaching Hospital in Stockton, Calif. Cross-resistance among quinolones has been observed; however, some quinolone-resistant isolates are susceptible to ZAGAM.

ZAGAM meets an important medical need because it has demonstrated broad coverage of today's community-acquired lower respiratory tract pathogens. ZAGAM is the first among a new generation of fluoroquinolones, which has demonstrated efficacy in the treatment of community-acquired pneumonia caused by susceptible strains of Chlamydia pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae or Streptococcus pneumoniae. In addition, ZAGAM is highly active in vitro against many penicillin-resistant strains of the Gram-positive pathogen, Streptococcus pneumoniae, as well as multi-drug resistant strains of the Gram- negative pathogens Haemophilus influenzae and Moraxella catarrhalis, although clinical efficacy has not yet been established.(B)

Battling Community-Acquired Pneumonia

Community-acquired pneumonia (CAP) strikes approximately four million Americans each year and hospitalizes about 600,000 with an annual cost of $23 billion. Approximately 500,000 cases of CAP each year are the result of infection with S. pneumoniae.(C)

"The benefit of ZAGAM is not only its effectiveness against many community-acquired lower respiratory tract pathogens, but its convenient once- a-day dosing which may enhance patient compliance," according to Dr. Bensch.

ZAGAM is indicated for the treatment of adults 18 years and older with CAP caused by susceptible strains of Chlamydia pneumoniae, Haemophilus infleunzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae or Streptococcus pneumoniae.

In clinical trials, in the evaluable populations, ZAGAM achieved a successful response in 86.4 percent of community-acquired pneumonia patients compared with a 80.7 percent success rate reported with erythromycin.(D) In another study, ZAGAM was shown to be comparable to cefaclor for the treatment of community-acquired pneumonia with the convenience of once-daily dosing; in patients where a bacterial pathogen was identified, the success rate with ZAGAM was 86.6 percent, versus 84.4 percent in patients who were given cefaclor. (E)

Warding Off Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB)

Chronic bronchitis afflicts approximately 14 million people every year.(F) Acute bacterial exacerbations occur when the patient develops a bronchial infection in addition to the pre-existing respiratory disease. If left untreated, patients with severe chronic bronchitis who develop acute bacterial exacerbations are more likely to develop additional complications. Lung function is so poor in these patients that even mild infections may lead to significant respiratory distress.

ZAGAM is indicated for the treatment of adults with ABECB caused by susceptible strains of Chlamydia pneumoniae, Enterobacter cloacae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Staphylococcus aureus, or Streptococcus pneumoniae.

Safety Profile

Moderate to severe photosensitivity reactions have occurred in patients exposed to direct or indirect sunlight or to artificial ultraviolet light (e.g., sunlamps) during or following treatment. Such exposure should be avoided while taking sparfloxacin and for five days following therapy. Sparfloxacin therapy should be discontinued immediately at the first sign or symptoms of photosensitivity. The most common adverse events occurring in clinical trials were photosensitivity reactions, nausea, and dizziness.

As with other quinolones, aluminum- and magnesium-based antacids, as well as sucralfate should only be administered at least two hours before or two hours after sparfloxacin administration. Zinc/iron salts should only be taken four hours after administering sparfloxacin. Sparfloxacin should not be used in patients with known QTc prolongation or in patients receiving QTc prolonging drugs.

Rhone-Poulenc Rorer Inc. is a global pharmaceutical company dedicated to improving human health. Last year, the company invested $882 million in research and development.

(A) Doern, GV, Bruggemann A., Holley, HP Jr., et al. Antimicrobial Agents an
 Chemotherapy. May 1996; 1208-1213.


(B) ZAGAM package insert, microbiology
 section.


(C) Bartlett JG. Current concepts: community-acquired pneumonia, New Engl an
 Journal of Medicine. 1995;333:1618-1624.


(D) Henry D, Stein W, Bensch G, et al. Treatment of community-acquired
 pneumonia with sparfloxacin and erythromycin. Presented at the 36th
 Interscience Conference on Antimicrobial Agents and Chemotherapy,
 Sept. 15-18, 1996.


(E) Branditz F, Salisbury J, Brandom M, et al. Treatment of community-
 acquired pneumonia with sparfloxacin and cefaclor. Presented at the 3 6t
 Interscience Conference on Antimicrobial Agents and Chemotherapy,
 Sept. 15-18, 1996.


(F) American Lung Association.

SOURCE Rhone-Poulenc Rorer Inc.
 -0- 5/19/97


/CONTACT: Doug Arbesfeld, 610-454-5889, or John Abrams, 610-454-5452, both of Rhone-Poulenc Rorer/

(RPR)

CO: Rhone-Poulenc Rorer Inc. ST: Pennsylvania IN: MTC SU: PDT

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