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Executive Summary

SCHERING's PROVENTIL $ 212 MIL. FIRST HALF SALES for 1991 puts the asthma treatment on track to easily eclipse 1990 sales of $ 315 mil. despite going off patent in late 1989. Schering-Plough VP Investor Relations Geraldine Foster told analysts at the Robert W. Baird Health Care Conference in Milwaukee on July 31 that the company expects Proventil second half sales to be lower than the first six months, however, and that projections of over $ 400 mil. for the year are "a bit optimistic." The firm expects to benefit from the absence of generic competition for the inhalent form of Proventil for the rest of 1991 while FDA continues to struggle with bioequivalence requirements for generics, Foster said. As part of its strategy for competing with the anticipated generic inhalents, Schering has filed for FDA approval of Gentlehaler, an inhaler with a "better mechanism of action," according to Foster. The company is also counting on physician reluctance to change medication "once they have an asthmatic stabilized," she noted. International sales of the non-sedating antihistamine Claritin (loratadine) are expected to reach $ 100 mil. this year, Foster said, which would represent a roughly 40% increase over 1990 sales. The drug is sold in 39 countries and is available OTC in Canada and several European countries. Foster described the June 13-14 FDA advisory committee finding that Claritin was "not likely" to be carcinogenic in humans as "the last hurdle" in obtaining approval in the U.S. The advisory committee made a similar finding for Pfizer's Reactine but was not asked to discuss efficacy or other safety aspects of the two antihistamines ("The Pink Sheet" June 24, p. 7). Claritin already has cleared one advisory committee review in October 1987. In response to a question about Claritin's efficacy, Foster pointed to the quick acceptance of the drug in Europe, noting that it garnered a 17% to 25% market share "literally overnight" and has maintained its share of the market with the exception of the U.K. where the firm has "a very weak sales force." Schering is "still looking at taking [Claritin] from prescription to OTC in the U.S." Foster indicated that the company plans to use seeding studies to support the OTC switch and has slowed down on patient enrollment while it concentrates on winning approval for the prescription product. She said the company also plans to use data from OTC patient populations in Canada and Europe. The most recent Schering Rx-to-OTC switch product, the anti- fungal Gyne-Lotrimin for vaginal yeast infections is on target for sales of $ 100 mil. in its first year, Foster said. Schering plans to file for approval of two drugs before the end of the year: the once-daily nitrate angina treatment Imdur (isosorbide-5-mononitrate) and Cedax, a once-a-day third generation cephalosporin for upper and lower respiratory infections and upper and lower urinary tract infections, for both adult and pediatric use. Cedax may be approved this year in Italy, Foster said. The firm is predicting the antibiotic will eventually generate over $ 100 mil. in sales and is touting its side effect profile, particularly the lack of gastrointestinal problems associated with it. Although Proventil is still Schering's biggest seller, the firm expects its alpha interferon Intron A to generate $ 275 mil. in sales in 1991, boosted by the approval of an expanded indication for hepatitis C earlier this year in the U.S. If the projection is accurate, Intron A sales will jump 57% from its 1990 sales of $ 175 mil. Foster noted that approval for hepatitis B indication will probably not produce a dramatic rise in sales but rather "slow steady growth" due to the need for a "massive educational process." An NDA for the hepatitis B indication is pending at FDA.

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