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Executive Summary

SCHERING PLANS TO CARVE CLARITIN NICHE WITH MAJOR SALES FORCE support, putting up to 1,400 to 1,500 sales reps behind the non-sedating antihistamine (loratadine) when it receives U.S. marketing clearance from FDA. Playing catch-up in the non-sedating prescription antihistamine market where Marion Merrell Dow and J&J's Janssen are already established, Schering promises to give the product top detailing. Schering-Plough Pharmaceutical Division President Donald Conklin previewed the company's marketing plans for Claritin at a seminar sponsored by Mabon Nugent in New York City on Nov. 20. Schering has "got a good story, a good product and you can bet your boots that we're" going to put the full Schering Labs field force and the Key Pharmaceuticals group behind the product, Conklin said. Loratadine was recommended for approval by FDA's Pulmonary-Allergy Drugs Advisory Committee in October 1987; however, the drug has been held up pending the resolution of the bioequivalence issue between the capsule dosage form used by Schering in its clinicals and the tablet form for which the firm is seeking approval. Schering doesn't know "of any major hurdle with the FDA on Claritin," Conklin said. "There have been some technical questions asked. We've been answering them," Conklin said, predicting: "I don't think we're going to get our final resolution until early next year, but we still expect it in the near future." * Conklin said he expected that FDA approval of the loratadine/pseudoephedrine combination Claritin D would follow "about nine months after Claritin." "I don't think we're too badly hurt" by being the third non-sedating antihistamine on the market, Conklin remarked. In Europe, Claritin has been "capturing a 15-20% market share the first year with the exception of the U.K.," where the brand competes with both Hismanal and cetirizine (UCB of Belgium's product licensed to Pfizer as Zyrtec). In the U.K., " we've been slow off the blocks, with only 4-5% in the first six months," Conklin reported. However, "the rest of our experience," he said, "is around 20%." In Canada, Claritin is the "leading brand being used by physicians," he added. Because of the slow progress of Claritin and several other late-stage Schering development projects, the company faces the possibility of several simultaneous or close proximity product introductions. The other two pending significant NDA approvals for Schering are the theophylline Uni-Dur as a once-a-day bronchodilator/anti-asthma product, and its vasodilating beta blocker antihypertensive Unicard (dilevolol). "I think they're probably going to be, from one to the other, probably nine months apart" for FDA approval, Conklin forecast. In response to a question on whether Schering's sales force would be adequate to handle three major introductions in a nine-month period, the pharmaceutical division exec said: "If we have to, we'll bring in contract field forces as well." "We are going to have very competitive promotional activity" for the three products, Conklin said, adding, however "I can't tell exactly how it's going to work out." Schering will "certainly" use its own 1,400 to 1,500 person U.S. sales force "full blast" for Claritin and "we're going to use them for Unicard, there's no doubt about that," Conklin said. As for "extra help," he noted that Schering has a dermatology sales force of 130 reps "which we could bring in . . . and which we would for some configuration of that. Probably Uni-Dur would get some help from that force," he noted. Schering also has a 60-person oncology force, a "couple hundred half-time" reps detailing the company's OTC product line to physicians, and a 60-person hospital force which could be enlisted to detail Claritin, Uni-Dur and Unicard. The hospital sales force is being expanded to 80 or 90. Conklin told analysts that Schering has recently completed a review of its sales force's ability to meet future marketing needs for the firm. "We may be 50-60 short" on sales reps, he said, "but we're close to the range for the product line that we have." The timing of FDA approval for Unicard is unclear, but Schering is guessing "sometime next year, hopefully the middle of next year," Conklin said. The drug has a "dual action of both vasodilating and protecting the heart through blockade, and we think this could be a very big product," he predicted. Unicard is "more effective" than ACE inhibitors in "terms of the percent of patients" with moderate to severe hypertension who show a "gain or response and at the same time appears to have half the safety profile of an ACE inhibitor, which is quite low compared to the traditional beta blockers," Conklin remarked. "You don't get the fatigue or the possible hypotension" or other side effects "traditionally associated with other beta blockers." Unicard was approved recently in Japan and will be launched in January. Schering is predicting sales next year "in excess of $ 70 mil." from Japan, Conklin said. Loratadine will be marketed simultaneously by Schering under its tradename and by Shionogi, Japan under its trademark. Several European launches are also expected during 1990.

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