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Executive Summary

Schering-Plough's advanced prostate cancer treatment, Eulexin (flutamide), is producing sales of roughly $ 3 mil. per month after nine months on the U.S. market, Schering Labs President Jean-Pierre Garnier told securities analysts at a Nov. 30 meeting in Kenilworth, N.J. "After the initial pipeline fill, based on enthusiastic acceptance from urologists," Garnier said, "we are now running at about $ 3 mil. a month and growing each and every month." Eulexin was launched in February. Based on revenues for Eulexin and Intron A (alfa interferon), Schering's domestic oncology sales for the first nine months reached $ 27 mil., according to company reports. Looking ahead, Garnier said the company expects Eulexin to "become the number one product in this market segment within the next six months." International sales of Eulexin in 1989 will approach $ 50 mil., reported Schering-Plough International President Raul Cesan. The product is sold in virtually all the firm's markets abroad with the exception of the U.K. and Australia. Intron A sales are "growing faster than expected," Garnier said. The company predicted at an Nov. 20 meeting sponsored by Mabon Nugent that worldwide sales for Intron A would reach $ 85 mil. this year and would exceed $ 100 mil. in 1990, with a boost from hepatitis indications abroad. Schering-Plough filed an NDA for Intron A in hepatitis C in June 1989, followed by an application for hepatitis B in September. Company-sponsored studies in hepatitis C were published in the Nov. 30 New England Journal of Medicine (see related T&G). * In a discussion of the firm's asthma/allergy line, Garnier said that Proventil (albuterol) "is having another banner year" and is on track to break $ 200 mil. in sales this year. Proventil sales were ahead 57% through September. The firm is concerned over upcoming patent expirations for albuterol (falling at the beginning of this month according to information in FDA's "Orange Book") but is predicting that the ongoing generic drug upheaval at FDA may slow generic approvals. "The only major issue facing our U.S. business is the patent expiration on albuterol and the question is when will we see generics for Proventil inhaler," Garnier said. Noting that "following the generic drugs scandal, the number of ANDA approvals has come down to a mere trickle," he suggested: "the generics will be late." At the Nov. 20 meeting with analysts, Schering-Plough Pharmaceuticals President Donald Conklin explained that some product shifting to protected forms will also limit generic incursion. In the Proventil tablet business, Conklin reported, "we've got about half that busness converted to Proventil Repetabs . . . That's impossible for generics to come in with right away." In the inhalant market, Conklin does not expect generic competition until the third quarter of 1990. He said Schering expects FDA to come out with the guidelines that generic firms need to test generic inhalers "sometime during December." Schering is also working on an "improved device," Conklin reported, that has been preferred by patients on whom it has been tested. He said the product has been in-licensed. It also is "tied up" by the pending FDA guidelines. The patent on the firm's antifungal, clotrimazole (Lotrimin), also expires in December, Garnier noted. However, he pointed out, the expiration will not affect the firm's related topical antifungal and anti-inflammatory, Lotrisone. A betamethasone/clotrimazole combination, Lotrisone "is fully patent protected beyond the year 2000," he said. The firm also has a clotrimazole/mometasone combination in Phase III testing as a topical antifungal and anti-inflammatory. Schering may be able to build a de facto extension of exclusivity for clotrimazole itself through the OTC introduction of Lotrimin AF for three of the ingredient's five prescription indications ("The Pink Sheet" Oct. 30, T&G-1) (see following story). Lotrisone sales for the nine months were ahead 32% and the product "will break $ 60 mil. in sales this year," Garnier predicted. Dermatological product sales totaled $ 148 mil. for the first three quarters. Garnier said the firm's U.S. pharmaceutical sales rose 24% for the nine months while the domestic "operating contribution" was up 36%. Schering-Plough's worldwide sales through September rose 7% to $ 2.4 bil. and net income increased 21% to $ 360.2 mil. The company is discussing final labeling for its long-pending application for the non-sedating antihistamine, Claritin (loratadine) and expects "to receive an approvability letter in the very near future," Schering-Plough President and Chief Operating Officer Richard Kogan said. Schering is preparing to devote its entire Schering Labs and Key Pharmaceuticals sales forces, totaling between 1,400 and 1,500, to marketing Claritin in the U.S. once it is approved ("The Pink Sheet" Nov. 27, T&G-5). Claritin is in 23 markets abroad and is expected to have 1989 sales of over $ 30 mil. The firm is working on additional indications for Claritin and is planning an OTC switch, Kogan noted. He said the firm is conducting Phase III trials in chronic urticaria and is in Phase III development with a syrup form of the drug for allergic rhinitis. In addition, he said, "we've already begun acquiring patients and amassing a data base so that, very soon after FDA approval, we'll have the capability to seek an OTC approval." Approval is expected in 1990 for the firm's vasodilating beta blocker antihypertensive Unicard (dilevalol). The firm announced Nov. 28 that the drug had been approved for marketing in Japan and is expected to be launched there in mid-December. The firm will co-market the drug in Japan with Shionogi. Once established in the U.S. and abroad, "we believe that our worldwide sales of Unicard will eventually exceed $ 200 mil. annually and, if you include our licensed sales, will probably exceed $ 300 mil.," Kogan said. Dilevalol has a "potentially favorable" effect on blood lipids and the firm has a study underway to assess the impact of the drug on HDL cholesterol in high risk patients, the company said. With regard to products further back in the pipeline, the firm is targeting a late 1991 NDA filing for its triazole antifungal, SCH 39304. Schering-Plough has an oral form of the drug in Phase II/III testing and expects to have an intravenous form in clinicals by the first quarter of 1990. The company plans to begin NDA filings in 1990 for GM-CSF, Kogan said. The compound is in Phase II/III study as an adjuvant to AIDS therapy (with AZT), as an adjuvant to chemotherapy, in autologous bone marrow transplantation and for myelodysplastic syndrome. While the firm will not specify which indications will be sought initially, Robert Speigel, MD, senior director, clinical research for oncology/anti-infectives and general medicine/OTC, commented: "we intend to have a broad label for GM-CSF." Kogan discussed a new hypertension and congestive heart failure product, an atriopeptidase inhibitor currently in Phase I/II clinicals. The drug works, he explained, by slowing "the breakdown of the atrial natriuretic peptide . . . which is a potent hormone released from the heart. Because API can keep this peptide active and working in the human body, it can reduce blood pressure by causing salt and water loss and by inhibiting the renin angiotensin system." He added that API also seems to work "synergistically" with ACE inhibitors. The company has submitted an IND application for the product and expects to complete an evaluation in hypertensive patients by the end of this year. Pilot studies in heart failure have been initiated and ACE synergy studies are to begin in the first quarter of 1990. Interleukin-4, a lymphokine cloned and expressed at Schering's DNAX Research Institute, entered Phase I testing early in November, Kogan noted. The drug "has a stimulating effect on the immune system and may be useful in treating a number of immuno-deficient diseases," he said.

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