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| |  Two Asthma/Allergy Supplementary NDAs Submitted to the FDA COLLEGEVILLE, Pa., Oct. 22, 1996 -- Rhone-Poulenc Rorer Inc. (NYSE: RPR) announced today that the Company has recently submitted two supplementary New Drug Applications (sNDAs) in the area of asthma/allergy medicine. The sNDAs were submitted for Tilade(R) (nedocromil sodium) Nebulizer Solution for use in maintenance therapy in the management of mild- to-moderate bronchial asthma in adults and children aged 2 and older, and for Nasacort(R) AQ (triamcinolone acetonide) Nasal Spray in the treatment of seasonal and perennial allergic rhinitis symptoms in children aged 4-11. Tilade Nebulizer Solution is a new dosage form of RPR's Tilade Inhalation Aerosol, a nonsteroidal anti-inflammatory that is currently available for maintenance therapy in the management of patients with mild-to-moderate bronchial asthma. If approved, the new nebulizer solution dosage form will be of particular benefit to asthma sufferers who may have difficulty using a metered-dose inhaler (MDI) -- for example, children and the elderly. This supplementary NDA is based on the results of three 12-week, double-blind, placebo-controlled multicenter trials, involving a total of 634 mild- to-moderate asthma patients, age 2 and older. Significant reductions in asthma symptoms, including cough, were noted in patients treated with Tilade Nebulizer Solution four times a day. In patients with relatively mild symptoms, a three-times-a-day regimen also significantly reduced symptoms and increased the number of symptom-free days. Statistically significant reductions in symptoms were seen with both regimens, as early as the first or second day of treatment. Adverse effects reported in the trials and occurring more frequently in those receiving Tilade (vs. placebo) were unpleasant taste and diarrhea. The sNDA for Nasacort AQ Nasal Spray, a once-daily, water-based, odorless, taste-free nasal spray for the treatment of allergic rhinitis, seeks FDA clearance to extend the product's benefits to children as young as 4 years of age. The safety and efficacy of Nasacort AQ Nasal Spray, at doses of 110 mcg or 220 mcg once daily, were studied in two double-blind, placebo-controlled trials involving 538 children with seasonal or perennial allergic rhinitis. Nasacort AQ administered at either dose resulted in statistically significant reductions of allergic rhinitis symptoms. The most commonly reported adverse effects were pharyngitis, fever, rhinitis and flu syndrome. Asthma is a chronic inflammatory condition that affects more than 10-12 million Americans -- including 4.8 million children -- and morbidity and mortality continue to rise. An estimated 26 million Americans suffer from allergic rhinitis, including more than 4 million children. Rhone-Poulenc Rorer is a global pharmaceutical company dedicated to improving human health. In 1995, RPR had sales of $5.316 billion (pro forma) and invested $826 million (pro forma) in research and development.
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