TEQUIN(R), Bristol-Myers Squibb's Quinolone Antibiotic, Surpasses 2.5 Million New Prescription Mark in U.S.

TEQUIN Continues to Set Quinolone Prescribing Records



Apr 19, 2001, 01:00 ET from Bristol-Myers Squibb Company

    PRINCETON, N.J., April 19 /PRNewswire/ -- Bristol-Myers Squibb Company
 (NYSE:   BMY) announced that TEQUIN(R) (gatifloxacin), an advanced-generation
 quinolone antibiotic, has passed the 2.5 million new prescription mark in the
 United States.  Approved by the U.S. Food and Drug Administration in December
 1999, TEQUIN achieved this milestone faster than any quinolone antibiotic in
 the United States, according to audited data (March, 2001) from IMS Ltd.
     "Bristol-Myers Squibb is pleased that physicians continue to recognize the
 clinical efficacy and safety of TEQUIN," said Richard J. Lane, president,
 Worldwide Medicines Group, Bristol-Myers Squibb.  "The rapid acceptance of
 TEQUIN underscores the commitment of Bristol-Myers Squibb to the treatment of
 infectious diseases and continued research in this area."
     According to new data from the landmark TeqCES (TEQUIN(R) Clinical
 Experience Study) community trial of respiratory tract infection (RTI)
 patients, TEQUIN is proving to be a particularly effective and safe treatment
 for two of the most frequently seen RTIs, acute sinusitis and acute bacterial
 exacerbations of chronic bronchitis (ABECB) due to susceptible strains of
 indicated bacteria.  More than 15,000 patients were enrolled in the trials, of
 which 10,353 were treated with TEQUIN for acute sinusitis and 2,267 for ABECB.
 The data showed a 92 percent overall clinical cure rate for sinusitis and
 bronchitis patients, even for smokers.  Cure rates in sinusitis and bronchitis
 from clinical trials used as a basis for approval were up to 88 percent.  No
 unexpected adverse events were reported.  The most common side effects
 associated with TEQUIN in clinical trials were gastrointestinal.  Adverse
 reactions considered to be drug related and occurring in greater than or equal
 to three percent of patients were: nausea (8%), vaginitis (6%), diarrhea (4%),
 headache (3%) and dizziness (3%).
     TeqCES is a prospective, noncomparative multicenter clinical study of
 community-based respiratory infections.  Adult patients 18 years and older
 received 400 mg TEQUIN QD for seven to 10 days for bronchitis and 10 days for
 sinusitis.
     Since March 2000, Bristol-Myers Squibb and Schering-Plough Corporation, a
 leading developer and marketer of respiratory products, have been co-marketing
 TEQUIN in the United States.  The combined resources of both companies create
 excellent synergies for the promotion of TEQUIN (gatifloxacin).
     In December 2000, Bristol-Myers Squibb filed for a five-day bronchitis
 indication with the FDA and action is anticipated in the fourth quarter of
 2001.  TEQUIN is used for indicated community-acquired RTIs and is dosed 400
 mg daily for these indications.  Dosage adjustments are required in patients
 with impaired renal function (creatinine clearance, less than 40mL/min).  The
 availability of TEQUIN in bioequivalent 400 mg oral and IV formulations
 facilitates transition for patients who begin treatment in the hospital and
 continue on oral therapy at home.
     TEQUIN is primarily excreted through the kidneys and less than one percent
 is metabolized by the liver.  In a clinical study (n=48), TEQUIN demonstrated
 a lower potential for producing delayed photosensitivity skin reactions than
 ciprofloxacin or lomefloxacin, and was comparable to placebo in causing these
 same reactions.
     TEQUIN(R) (gatifloxacin) may have the potential to prolong the QTc
 interval of the electrocardiogram in some patients, and, due to limited
 clinical experience, TEQUIN should be avoided in patients with known
 prolongation of the QTc interval, patients with uncorrected hypokalemia and
 patients receiving Class IA (e.g., quinidine, procainamide) or Class III
 (e.g., amiodarone, sotalol) antiarrhythmic agents.  TEQUIN should be used with
 caution when given together with drugs that may prolong the QTc interval
 (e.g., cisapride, erythromycin, antipsychotics, tricyclic antidepressants),
 and in patients with ongoing proarrhythmic conditions (e.g., clinically
 significant bradycardia or acute myocardial ischemia).
     The safety and efficacy of TEQUIN in children, adolescents (under 18),
 pregnant women and nursing mothers have not been established.  TEQUIN is
 contraindicated in persons with a history of hypersensitivity to gatifloxacin
 or any member of the quinolone class of antimicrobial agents.  As with other
 quinolones, TEQUIN should be used with caution in patients with known or
 suspected central nervous system disorders or patients who have a
 predisposition to seizures.
     Oral doses of TEQUIN(R) (gatifloxacin) should be administered at least
 four hours before the administration of ferrous sulfate, dietary supplements
 containing zinc, magnesium, or iron (such as multivitamins),
 aluminum/magnesium containing antacids or VIDEX(R) (didanosine).  Concomitant
 administration of TEQUIN and probenecid significantly increases systemic
 exposure to TEQUIN.  Concomitant administration of TEQUIN and digoxin did not
 produce significant alteration of the pharmacokinetics of TEQUIN; however,
 patients taking digoxin should be monitored for signs and/or symptoms of
 digoxin toxicity.
     Concomitant administration of TEQUIN (as with other quinolones) in
 diabetic patients taking oral antidiabetic agents, with or without insulin,
 may produce symptomatic disturbances in blood sugar levels.  Blood sugar
 levels in these patients should be carefully monitored during treatment with
 TEQUIN.  If a hypoglycemic reaction occurs, initiate appropriate therapy
 immediately and discontinue TEQUIN.
     TEQUIN was licensed by Bristol-Myers Squibb from Kyorin Pharmaceutical
 Company Ltd. in September 1996, for development and marketing in the U.S.,
 Argentina, Australia, Brazil, Canada, Mexico, and certain other countries.
     Bristol-Myers Squibb is a $20 billion diversified, global health and
 personal care company whose mission is to extend and enhance human life.
 Bristol-Myers Squibb is a worldwide leader in infectious disease, including
 worldwide surveillance tracking programs to monitor the effectiveness of anti-
 infective therapies.  SENTRY Antimicrobial Surveillance Program is an ongoing
 tracking program that collects data from hospitals.  RESP (REspiratory
 Surveillance Program) is the first national program to study the bacterial
 causes of community RTIs, and to determine the incidence of bacterial
 resistance to frequently used antibiotics at local, regional and national
 levels.
     For full prescribing information on TEQUIN(R) (gatifloxacin), please
 contact Stephanie E. Brooks at 609-897-4129.  Visit TEQUIN's Internet press
 room on the World Wide Web at http://www.TEQUIN.com.
 
     CONTACT:  Stephanie E. Brooks of Bristol-Myers Squibb, 609-897-4129, or
 stephanie.brooks@bms.com.
 
 

SOURCE Bristol-Myers Squibb Company
    PRINCETON, N.J., April 19 /PRNewswire/ -- Bristol-Myers Squibb Company
 (NYSE:   BMY) announced that TEQUIN(R) (gatifloxacin), an advanced-generation
 quinolone antibiotic, has passed the 2.5 million new prescription mark in the
 United States.  Approved by the U.S. Food and Drug Administration in December
 1999, TEQUIN achieved this milestone faster than any quinolone antibiotic in
 the United States, according to audited data (March, 2001) from IMS Ltd.
     "Bristol-Myers Squibb is pleased that physicians continue to recognize the
 clinical efficacy and safety of TEQUIN," said Richard J. Lane, president,
 Worldwide Medicines Group, Bristol-Myers Squibb.  "The rapid acceptance of
 TEQUIN underscores the commitment of Bristol-Myers Squibb to the treatment of
 infectious diseases and continued research in this area."
     According to new data from the landmark TeqCES (TEQUIN(R) Clinical
 Experience Study) community trial of respiratory tract infection (RTI)
 patients, TEQUIN is proving to be a particularly effective and safe treatment
 for two of the most frequently seen RTIs, acute sinusitis and acute bacterial
 exacerbations of chronic bronchitis (ABECB) due to susceptible strains of
 indicated bacteria.  More than 15,000 patients were enrolled in the trials, of
 which 10,353 were treated with TEQUIN for acute sinusitis and 2,267 for ABECB.
 The data showed a 92 percent overall clinical cure rate for sinusitis and
 bronchitis patients, even for smokers.  Cure rates in sinusitis and bronchitis
 from clinical trials used as a basis for approval were up to 88 percent.  No
 unexpected adverse events were reported.  The most common side effects
 associated with TEQUIN in clinical trials were gastrointestinal.  Adverse
 reactions considered to be drug related and occurring in greater than or equal
 to three percent of patients were: nausea (8%), vaginitis (6%), diarrhea (4%),
 headache (3%) and dizziness (3%).
     TeqCES is a prospective, noncomparative multicenter clinical study of
 community-based respiratory infections.  Adult patients 18 years and older
 received 400 mg TEQUIN QD for seven to 10 days for bronchitis and 10 days for
 sinusitis.
     Since March 2000, Bristol-Myers Squibb and Schering-Plough Corporation, a
 leading developer and marketer of respiratory products, have been co-marketing
 TEQUIN in the United States.  The combined resources of both companies create
 excellent synergies for the promotion of TEQUIN (gatifloxacin).
     In December 2000, Bristol-Myers Squibb filed for a five-day bronchitis
 indication with the FDA and action is anticipated in the fourth quarter of
 2001.  TEQUIN is used for indicated community-acquired RTIs and is dosed 400
 mg daily for these indications.  Dosage adjustments are required in patients
 with impaired renal function (creatinine clearance, less than 40mL/min).  The
 availability of TEQUIN in bioequivalent 400 mg oral and IV formulations
 facilitates transition for patients who begin treatment in the hospital and
 continue on oral therapy at home.
     TEQUIN is primarily excreted through the kidneys and less than one percent
 is metabolized by the liver.  In a clinical study (n=48), TEQUIN demonstrated
 a lower potential for producing delayed photosensitivity skin reactions than
 ciprofloxacin or lomefloxacin, and was comparable to placebo in causing these
 same reactions.
     TEQUIN(R) (gatifloxacin) may have the potential to prolong the QTc
 interval of the electrocardiogram in some patients, and, due to limited
 clinical experience, TEQUIN should be avoided in patients with known
 prolongation of the QTc interval, patients with uncorrected hypokalemia and
 patients receiving Class IA (e.g., quinidine, procainamide) or Class III
 (e.g., amiodarone, sotalol) antiarrhythmic agents.  TEQUIN should be used with
 caution when given together with drugs that may prolong the QTc interval
 (e.g., cisapride, erythromycin, antipsychotics, tricyclic antidepressants),
 and in patients with ongoing proarrhythmic conditions (e.g., clinically
 significant bradycardia or acute myocardial ischemia).
     The safety and efficacy of TEQUIN in children, adolescents (under 18),
 pregnant women and nursing mothers have not been established.  TEQUIN is
 contraindicated in persons with a history of hypersensitivity to gatifloxacin
 or any member of the quinolone class of antimicrobial agents.  As with other
 quinolones, TEQUIN should be used with caution in patients with known or
 suspected central nervous system disorders or patients who have a
 predisposition to seizures.
     Oral doses of TEQUIN(R) (gatifloxacin) should be administered at least
 four hours before the administration of ferrous sulfate, dietary supplements
 containing zinc, magnesium, or iron (such as multivitamins),
 aluminum/magnesium containing antacids or VIDEX(R) (didanosine).  Concomitant
 administration of TEQUIN and probenecid significantly increases systemic
 exposure to TEQUIN.  Concomitant administration of TEQUIN and digoxin did not
 produce significant alteration of the pharmacokinetics of TEQUIN; however,
 patients taking digoxin should be monitored for signs and/or symptoms of
 digoxin toxicity.
     Concomitant administration of TEQUIN (as with other quinolones) in
 diabetic patients taking oral antidiabetic agents, with or without insulin,
 may produce symptomatic disturbances in blood sugar levels.  Blood sugar
 levels in these patients should be carefully monitored during treatment with
 TEQUIN.  If a hypoglycemic reaction occurs, initiate appropriate therapy
 immediately and discontinue TEQUIN.
     TEQUIN was licensed by Bristol-Myers Squibb from Kyorin Pharmaceutical
 Company Ltd. in September 1996, for development and marketing in the U.S.,
 Argentina, Australia, Brazil, Canada, Mexico, and certain other countries.
     Bristol-Myers Squibb is a $20 billion diversified, global health and
 personal care company whose mission is to extend and enhance human life.
 Bristol-Myers Squibb is a worldwide leader in infectious disease, including
 worldwide surveillance tracking programs to monitor the effectiveness of anti-
 infective therapies.  SENTRY Antimicrobial Surveillance Program is an ongoing
 tracking program that collects data from hospitals.  RESP (REspiratory
 Surveillance Program) is the first national program to study the bacterial
 causes of community RTIs, and to determine the incidence of bacterial
 resistance to frequently used antibiotics at local, regional and national
 levels.
     For full prescribing information on TEQUIN(R) (gatifloxacin), please
 contact Stephanie E. Brooks at 609-897-4129.  Visit TEQUIN's Internet press
 room on the World Wide Web at http://www.TEQUIN.com.
 
     CONTACT:  Stephanie E. Brooks of Bristol-Myers Squibb, 609-897-4129, or
 stephanie.brooks@bms.com.
 
 SOURCE  Bristol-Myers Squibb Company

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