Executive Summary

Schering-Plough has assembled a team of about 1,000 Schering and Key sales reps for the anticipated approval of Uni-Dur early next year, President Richard Kogan told financial analysts in a Nov. 30 presentation at the company's Kenilworth, New Jersey R&D headquarters. "FDA approval is expected in early 1989 and as soon as we have it, a team of about 1,000 Schering and Key salespeople will detail Uni-Dur to 16,000 physicians," Kogan said. "In fact, we are so confident about the drug that we are having sales meetings this week to prepare for this launch." The once-a-day theophylline product "offers a consistent therapeutic level throughout the dosage period," according to Kogan, "making it the only truly 24-hour theophylline product." Uni-Dur is a follow-up compound to the primarily two-a-day product Theo-Dur, which came to Schering as part of the Key acquisition in 1986. Theo-Dur controls about a 50% share of the U.S. theophylline market. The company's current mobilization of marketing resources in the direction of Uni-Dur indicates a less optimistic expectation for another product awaiting final FDA action, the non-sedating antihistamine Claritin (loratidine). Recommended for approval by FDA's Dermatologic Drugs Advisory Committee in October 1987, the Claritin NDA has been held up pending resolution of the bioequivalence issue between the capsule dosage form, used by Schering in its clinical studies, and the tablet formulation, for which the company is seeking approval. Schering has been affected by bioavailability parameters that were tightened, with the support of PMA member companies, early in 1988 ("The Pink Sheet" Feb. 15, p. 13). Kogan reported: "All such additional data has now been submitted and FDA is making its review," the exec noted. "There are no other outstanding issues with FDA on this product." While Claritin appeared to have the inside track on becoming the second non-sedating antihistamine launch in the U.S. after Merrell Dow's Seldane (terfenadine), it is now neck-and-neck with another pending NDA. In late October, Johnson & Johnson's Janssen unit received an "approvable" letter for Hismanal (astemizole). Nevertheless, Schering is still projecting annual sales of Claritin in the $200-300 mil. range once the product is fully established worldwide. Kogan noted that in France, loratidine achieved an 11% market share two months after its introduction. Given the company's preparations for Uni-Dur, a near-term approval for Claritin might necessitate the hiring of a contract sales force to assist in the product's rollout. Schering has done that in the past to add marketing muscle. Schering claims 50% of all prescription asthma volume in the U.S., where its Proventil (albuterol) brand has about one-third of the beta agonist bronchodilator market. The line accounts for about 5% of corporate volume, or about $150 mil., according to Kogan. Albuterol is also marketed in the U.S. by Glaxo under the Ventolin brand. FDA has recently begun discussing the criteria for generic bronchodilator approvals ("The Pink Sheet" Nov. 28, p. 11).