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| |  VANCERIL 84 mcg Double Strength Cleared For All Asthma Severities MADISON, N.J., Jan. 2, 1997 -- Schering-Plough Corporation (NYSE: SGP) announced today that VANCERIL(R) 84 mcg Double Strength (beclomethasone dipropionate, 84 mcg) Inhalation Aerosol has received marketing clearance for the treatment of asthma from the U.S. Food and Drug Administration (FDA). Building on the 20-year history of the proven efficacy and safety of VANCERIL(R) (beclomethasone dipropionate, USP), the new product will offer twice the medication per puff and true twice-daily dosing for adults and children age 6 and older. VANCERIL 84 mcg Double Strength will be marketed by Key Pharmaceuticals, a unit of Schering-Plough. The product, which received FDA clearance on Dec. 24, 1996, will be available nationwide this month. As a concentrated, twice-daily formulation with the same active ingredient as VANCERIL, VANCERIL 84 mcg Double Strength represents a significant step forward in simplifying asthma therapy. Available by prescription as a metered dose inhaler, VANCERIL 84 mcg Double Strength is indicated in the maintenance treatment of asthma as prophylactic therapy and for asthma patients who require systemic corticosteroid administration, where adding VANCERIL 84 mcg Double Strength may reduce or eliminate the need for systemic corticosteroids. "VANCERIL 84 mcg Double Strength provides convenient twice-daily dosing with half the puffs per dose as compared to regular strength VANCERIL," said Richard W. Zahn, president of Schering Laboratories, the U.S. prescription pharmaceutical marketing arm of Schering-Plough. "The convenience and safety of VANCERIL 84 mcg Double Strength will offer physicians and asthma patients a valuable tool in the management of the disease." Effective management of asthma with oral inhaled corticosteroids requires that patients comply with the prescribed dosing schedule. "For some patients, especially those requiring dosing of up to 10 puffs per day, compliance can be problematic," said Jay Grossman, M.D., medical director, Allergy Care Consultants, Ltd., Tucson, Ariz. "By delivering twice the amount of medication available per inhalation, VANCERIL 84 mcg Double Strength will offer asthma patients true twice-daily dosing with half the number of puffs per dose." PROVEN EFFICACY AND SAFETY The efficacy of VANCERIL 84 mcg Double Strength was demonstrated in randomized, double-blind, placebo-controlled clinical trials involving 423 patients with bronchial asthma who had been switched from other oral inhaled steroids. VANCERIL 84 mcg Double Strength dosed two puffs, twice-daily (BID) was shown to significantly improve pulmonary function and control other asthma symptoms. The usual recommended starting dosage for VANCERIL 84 mcg Double Strength is two puffs, twice daily for adults and children as young as 6 years old. In a randomized, four-week clinical trial, the incidence of adverse events for VANCERIL 84 mcg Double Strength was similar to that reported for placebo. The incidence of oral candidiasis was less than 1 percent. No hypothalamus-pituitary-adrenal (HPA) axis suppression was reported in a clinical study of adult patients who received daily doses of 840 mcg for 35.5 days. In 20 years of U.S. clinical experience, beclomethasone dipropionate (BDP), the active ingredient in VANCERIL and VANCERIL 84 mcg Double Strength, has demonstrated a very favorable systemic safety profile with regard to HPA axis suppression, bone metabolism, long-term growth in children and adverse events. CHRONIC ASTHMA: BOTH REAL AND PERSONAL COSTS An estimated 14 million Americans suffer from asthma, including 4 million children under the age of 18. A lung disease characterized by inflammation and obstruction of the airways that transport air from the nose and mouth to the lungs, asthma interferes with the lungs' life-supporting function of removing carbon dioxide from the blood and replacing it with oxygen. While there is no known cure, asthma can be controlled with medication. Asthma results in both direct and indirect costs to patients, their families and the health care system. "The single largest cost is for inpatient hospitalization, estimated at more than $1.5 billion per year," said Dr. Grossman. "In addition, an estimated 10 million schooldays are missed each year by children with asthma, resulting in nearly $1 billion in lost employment by adults caring for their children with asthma." Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide.
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