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VASOTEC WILL CROSS $ 1 BIL. ANNUAL SALES THRESHOLD IN 1988, VAGELOS PREDICTS; MEVACOR IS TOP U.S. INTRODUCTION; PROSTATE DRUG PROSCAR TO BEGIN PHASE III

Executive Summary

Vasotec (enalapril) should reach $ 1 bil. in annual worldwide sales by the end of 1988, Merck Chairman Roy Vagelos told a meeting with securities analysts in New York on Nov. 3. "Vasotec is our biggest drug," Vagelos reported, heading a stable that now includes 15 products with over $ 100 mil. in annual sales. "It will be this year, I believe this year, our first drug to reach $ 1 bil. per year," Vagelos predicted. "If it does not do it this year, it will surely do it next year." The adjunctive therapy congestive heart failure approval Vasotec received in late June has the ACE inhibitor growing rapidly in the U.S. Vagelos pointed out "that prolonged follow-up on the ]congestive heart failure clinical trial[ patients demonstrates that the reduction in mortality has continued." The ACE inhibitor class has a long-term potential for continued growth, Vagelos told the analysts. Asked to comment on the impending launch of new calcium channel blockers (see stories on pages 4-6), Vagelos declared: "I see no problems for ACE inhibitors for many years. And, in fact, there will be many ]new[ ACE inhibitors, that is for sure." Vagelos pointed out that the calcium channel blockers should continue to grow also. "We see that, absolutely, but they are quite different drugs. Their effectiveness is different; the side effect picture is different. For instance, the presently available calcium channel blockers for hypertension are no where close to the lack of side effects that you have with ACE inhibitors. There is no question about that." Mevacor (lovastatin) is also on a fast growth track. In its first 12 months on the U.S. market, the lipid-lowering agent was the top selling first year drug in U.S. history, with sales above $ 150 mil. Some estimates have put the product sales over $ 200 mil. in that period. Vagelos noted that approximately 700,000 patients have been treated with the drug since the start of marketing. Calling the product "terrifically effective," Vagelos reported that in long-term monitoring "750 patients now have been followed on the average three years. Some patients have been followed for up to six years. It is extremely well-tolerated: 2.2% of patients have discontinued therapy because of drug. No effect on the lens of the human eye is detectable with these drugs." Vagelos added that marked asymptomatic increases in certain liver enzymes ]in 1.3% of the long-term study patients[ were discovered early in development. The company notes "a return to normal levels . . . upon discontinuance of the drug." Vagelos recounted the wide range of Merck's current product successes in a matter-of-fact manner to the analysts. At one point, he said, "our competitive position in the U.S. today is not too different from in 1980: we have been number one in U.S. market share since 1980." For most of the the last nine years, Vagelos said, Merck "has been growing faster than the market. In 1988, as in 1987, we increased our lead over number two." He noted that this year the number two firm in the U.S. will be Glaxo, supplanting American Home Products. He commented on the difficulty of riding a crest, saying "the rapid growth that we have been experiencing is not unique to Merck: other companies with important new products -- either a breakthrough product or numerous products or devices -- have had periods of very rapid growth. Sustaining that growth and performance is the trick -- and that is the trick we hope to be able to establish at Merck." The current pipeline stories at Merck commanding the interest of the analysts are the prostate treatment Proscar (MK-906), the anti-ulcer drug Losec (omeprazole), and Prodiax (ponalrestat). Two of those products are in-licensed: omeprazole from Astra and ponalrestat from ICI. The Merck-discovered Proscar has most dramatically caught the imagination of the financial analysts; the first four questions in the open-floor period of the Nov. 3 meeting were on the drug (see text beginning on p. 9). The company reports that it is "scheduled to move ]Proscar[ into large-scale (Phase III) studies very soon." Merck company had its end-of-Phase II conference with FDA on Nov. 2, just one day prior to the analysts meeting. The first clinical effects of Proscar begin to show relatively quickly, within 12 weeks after administration of the drug. To maintain the effect, however, the drug must be taken on a maintenance schedule. When discontinued, the hypertrophy recurs. Merck is also getting ready to take anti-diabetic/aldose reductase inhibitor Prodiax into studies on diabetic retinopathy. "The question with Prodiax as with all other aldose reductase inhibitors is whether they will do the job clinically," Vagelos pointed out: "the problem is to translate ]biochemical findings[ into clinical improvement." He emphasized that Prodiax will have a long clinical development period. He said the studies are "very tough and . . . ongoing. It is going to take easily a year or more before we know that we have a product candidate." Losec, by contrast, is considered a near-term product candidate. Vagelos said that "gastroenterologists are very interested and very excited about a new mechanim of action drug." he explained that Losec will be for "short-term use, not as a maintenance drug for many, many years. It will be a very important drug and it will take a very important share of the market." MS&D Research Lab President Edward Scolnick, MD, added that "most H2 blockers are not used for chronic maintenance therapy; they are used repeatedly over and over again to treat the recurrent problems. And Losec will be able to be used probably the same way. It has been approved for that kind of use overseas by Astra. So I don't think that it will be at a major disadvantage." Merck pointed out that the drug "has outstanding efficacy in gastro-esophogeal reflux disease." One research product that is not making much progress is MK-801 as a neuroprotective agent. Vagelos twice mentioned the product to the analysts, pointing out that it is not in development. He said that the basic research group at Merck is "seeking additional animal models to demonstrate what it should be able to do." Asked about other wash-outs in Phase II, Vagelos said that "no drugs ]which had already reached Phase II trials[ had been stopped in 1988." He added: "We have had a remarkably clean year thus far, and I always knock on wood, because you never know what is going to happen when I pick up the phone."
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