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PROVENTIL REPETABS APPROVED JULY 14; B.I.D. ALBUTEROL FORMULATION COULD PUSH PRODUCT LINE SALES OVER $100 MIL. IN 1986, SCHERING's LUCIANO SAYS

Executive Summary

Schering-Plough's Proventil Repetabs, twice-daily albuterol line extension, approved July 14, could help lift the brand's total sales above $100 mil. in 1987, Chairman Robert Luciano indicated in a July 15 security analyst presentation. Noting that the new Proventil product will complement currently marketed tablet, syrup, inhaler and, solution for inhalation formulations, Luciano stated: "These line extensions, added to our sales and marketing expertise, have raised Proventil to the point where they should exceed $100 mil. this year." The twice daily formulation also should act as an additional hedge against generic competition when the albuterol patent expires in 1989. With sales of $79 mil. in 1986, up 36% over 1985, Proventil was the company's second largest-selling prescription medication in the U.S. For the twelve months ended March 31, Proventil's market share rose two share points to 29.2%, senior VP Ralph Golby noted. Schering licenses albuterol from Ventolin-manufacturer Glaxo and has exclusive rights to the long-acting 4 mg tablet formulation, the only beta agonist tablet now approved for U.S. marketing. Both firms market 2 and 4 mg albuterol products for administration three to four times daily, and indicated for relief of symptoms associated with asthma, bronchitis, emphysema and other respiratory disorders. Schering plans to launch the new sustained-release product in August. The firm submitted a full NDA for Proventil Repetabs in October 1985. "As second-line therapy for asthma, Proventil Repetab complements Theo-Dur, a first-line therapy and the company's leading prescription product," Schering said. Theor-Dur, a sustained-release theophylline product acquired in 1986 with the purchase of Key Pharmaceuticals, had a 56% share of the U.S. asthma market for the twelve months ended March 31, according to Golby, who added that the product's sales in the first half of 1987 were up "about 12%." As a result of Schering's recent realignment of its prescription detail force, both Proventil and Theo-Dur are marketed by a 600-rep field sales staff that details to allergists, ear, nose and throat physicians, pulmonary disease specialists and general practitioners. Another sales staff of 65 reps concentrate on dermatologists, while a hospital and cancer staff of 100 focuses on oncologists and hematologists in the institutional setting. A fourth group of 350 Key sales reps continues to detail most of the products obtained in that acquisition, including Nitro-Dur, a transdermal nitroglycerine patch product and K-Dur, a potassium supplement. In exchange for Theo-Dur, the Key detail force now has responsibility for Normodyne, a beta blocker that Schering also licenses from Glaxo. Golby noted that during 1987, cardiovascular sales have been growing at the 35% rate achieved in 1986 and predicted six-month sales of about $57 mil. He added that Normodyne continued to boost its share of the beta blocker market. "In 1986, it sales almost doubled to $28 mil., and in the first half of this year they were up about 28%," Golby said. Schering's total 1986 pharmaceutical sales were roughly $1.6 bil., of which only about 6%, or $100 mil., came from cardiovascular products. The company's presence in this area could be bolstered by the approval, expected "shortly," of Quinel-Dur, a Key sustained-release quinidine product for arrhythmia, and the approval of dilevalol, a vasodilating beta blocker for which an NDA is currently pending.
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