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| Bristol-Myers Squibb and Schering-Plough Announce U.S. Agreement To Co-Promote TEQUIN(TM) for Respiratory Infections |
PRINCETON and MADISON, N.J., March 13 /PRNewswire/ -- Bristol-Myers Squibb Company (NYSE: BMY), developer and marketer of the new broad-spectrum fluoroquinolone antibiotic TEQUIN(TM) (gatifloxacin), and Schering-Plough Corporation (NYSE: SGP), a leading developer and marketer of respiratory products, announced that beginning today they will co-promote TEQUIN in the United States. Launch performance of TEQUIN in new prescription volume, through its first two months on the market, has surpassed the launch performance of Levaquin(R) (levofloxacin) and Trovan(TM) (trovafloxacin), confirming that TEQUIN should compete extremely well with other antibiotics outside of the quinolone class. Schering-Plough is an outstanding partner for Bristol-Myers Squibb because of the company's focus on the respiratory and allergy markets and because of its exceptional selling power. TEQUIN is a member of the advanced generation quinolones that exert antibacterial effect on two bacterial enzyme systems. It was approved in December 1999 by the U.S. Food and Drug Administration for the treatment of community-acquired respiratory tract infections (RTIs) and other common indicated infections. TEQUIN is currently available to patients by prescription. "Bristol-Myers Squibb is very pleased to work with Schering-Plough to help physicians treat the RTIs that affect people every day, especially this time of year," said Richard J. Lane, president, Bristol-Myers Squibb Worldwide Medicines Group. "Both companies have decades-long experience and established reputations among general practice physicians and specialists. Given the need for additional therapeutic options to combat these tough infections, there is no question that this partnership will bring added value to our customers and patients," he said. "Schering-Plough has a significant presence in the respiratory, allergy and immunology markets, based on leading products and an experienced sales force," said Richard W. Zahn, president, Schering Laboratories. "These factors, combined with our strong relationship with office-based physicians who prescribe our allergy and asthma medications, create excellent synergies for the co-promotion of TEQUIN(TM) (gatifloxacin) with the Bristol-Myers Squibb sales force." Today's announcement stems from Bristol-Myers Squibb and Schering-Plough signing a contract to co-promote TEQUIN in the U.S. for an undisclosed period of time. Schering-Plough's sales force will begin promoting TEQUIN today. Financial details of the co-promotion agreement are not being disclosed. INDICATIONS TEQUIN has been shown in clinical trials to provide excellent efficacy and tolerability in the treatment of patients with acute exacerbation of chronic bronchitis, acute sinusitis and community-acquired pneumonia caused by indicated susceptible strains of gram-positive and gram-negative bacteria that include S. pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae and Legionella pneumoniae. TEQUIN has also been approved for the treatment of both complicated and uncomplicated urinary tract infections and pyelonephritis caused by susceptible microorganisms and for the treatment of gonorrhea. The incidence of RTIs, such as bronchitis, sinusitis and community- acquired pneumonia, has increased almost 50 percent in the past 10 years in the United States to approximately 125 million cases per year. The rise in RTIs has driven the development of newer antibiotics, such as macrolides and fluoroquinolones. The mechanism of action of fluoroquinolones, including TEQUIN, is different from that of penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines. There is no cross-resistance between TEQUIN and these classes of antibiotics. DOSAGE AND ADMINISTRATION The recommended dose for TEQUIN(TM) (gatifloxacin) is 400 mg once daily for all indications. Dosage modification is required in patients with impaired renal function. TEQUIN is available in bioequivalent 400 mg oral and I.V. formulations to facilitate an easy transition for patients who begin I.V. treatment in the hospital and continue on oral therapy at home. IMPORTANT INFORMATION TEQUIN is primarily excreted through the kidneys and less than one percent is metabolized by the liver. TEQUIN has been shown to be safe and well tolerated in 15 clinical trials at 500 study sites worldwide. To date, TEQUIN has been prescribed to more than 125,000 patients in the U.S. since entering the market. In one 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 reactions. The most common side effects associated with TEQUIN in clinical trials were gastrointestinal. Adverse events 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%). TEQUIN should not be administered within four hours before or after administration of an antacid or a mineral supplement, such as iron or calcium. 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. TEQUIN 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 administered 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). TEQUIN(TM) (gatifloxacin) was licensed by Bristol-Myers Squibb from Kyorin Pharmaceutical Company Ltd. in 1996 for development and marketing in the U.S. and certain other countries. Bristol-Myers Squibb is the largest manufacturer of penicillin in the world and the maker of some of the most prescribed antibiotics for adults and children, including TRIMOX(R) (amoxicillin), PRINCIPEN(R) (ampicillin), CEFZIL(R) (cefprozil) and DURICEF(R) (cefadroxil). Schering-Plough is a recognized leader in the development and marketing of allergy/respiratory products. Leading allergy products include the CLARITIN(R) (loratadine) nonsedating antihistamine line, NASONEX(R) (mometasone furoate monohydrate) Nasal Spray and VANCENASE(R) AQ 84 mcg Double Strength (beclomethasone dipropionate monohydrate) Nasal Spray. Bristol-Myers Squibb is a diversified, worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer medicines, beauty care, nutritionals, and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products. Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. Levaquin(R) (levofloxacin) is a product of Ortho-McNeil Pharmaceutical. Trovan(TM) (trovafloxacin) is a product of Pfizer Inc. For full prescribing information for TEQUIN(TM) (gatifloxacin) contact Tracy Furey of Bristol-Myers Squibb. Visit the TEQUIN(TM) (gatifloxacin) web site at http://www.bms.com/tequin.SOURCE Bristol-Myers Squibb Company
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CONTACT:
Tracy Furey of Bristol-Myers Squibb,
609-252-3208, or tracy.furey@bms.com, or William O'Donnell of
Schering-Plough, 973-822-7476, or william.odonnell@spcorp.com
