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Executive Summary

Squibb's NDA for the cholesterol-lowering agent pravastatin will include data from nearly 2,000 patients taking the drug for at least one year, Squibb Institute for Medical Research President George Mackaness, MD, reported at a Sept. 22 health care R&D conference in New York City sponsored by Prudential-Bache. "There are 57 studies ongoing in 160 centers throughout the world, most of them in the U.S.," Mackaness said. "By the time we close the files . . . there will be 1,250 U.S. subjects to which we will be able to add at least another 600 from the studies conducted by Sankyo in Japan. So we will have close to 2,000 cases followed for a period of a year or more when we make our filing." Noting that the drug is still on target for an NDA filing in the first half of 1988, Mackaness presented results of Phase II studies that showed pravastatin reducing low-density lipoprotein (LDL) levels in excess of 30% within eight weeks. Patients receiving 40 mg once daily experienced a 27% drop when taken in the morning and a 37% reduction when taken in the evening. Those receiving 20 mg b.i.d. showed a 35% decrease in LDL after eight weeks. "The drug is doing its thing with remarkably little complaint from patients," he said, adding that Squibb is now spending "a major portion" of its R&D resources on cholesterollowering agents. Licensed from Sankyo, pravastatin could be the second HMG-CoA reductase inhibitor to reach the U.S. market, following Merck's Mevacor (lovastatin), approved Sept. 1. Squibb has exclusive rights to pravastatin outside of Japan, Korea, Taiwan and Thailand. Mackaness also discussed the status of its ACE inhibitor Capoten for use as a first-line treatment for congestive heart failure (CHF). "We have a filing with the FDA which . . . has to do specifically with the use of ACE inhibitors, and captopril in particular, in mild to moderate CHF, much larger than the indication for which captopril has now been approved, namely in third and fourth stage CHF," he said. FDA's Cardio-Renal Drugs Advisory Committee will meet Oct. 13 to discuss the expanded use of ACE inhibitors in the treatment of CHF. Capoten is currently approved for CHF patients who do not respond to digitalis and diuretics. "There is now clear evidence," Mackaness continued, "of improved survival in patients that have CHF." He cited results of a placebo-controlled mortality study of 105 CHF patients, in which over 95% of the group taking Capoten plus digitalis survived after 90 days of therapy, compared to approximately 80% of the group receiving digitalis and placebo. Mackaness noted that Squibb is funding a large-scale, U.S. mortality study of captopril, organized by a panel of academic experts, that is expected to last five years. The impetus, he said, were studies of animals with experimental coronary occulsions maintained on captopril that showed a 60% improvement in mortality compared to those that were untreated. In the antibacterial area, the company's primary focus is in narrow-spectrum antibiotics, specifically monobactams. Squibb launched its first monobactam product, Azactam (aztreonam), in 1987. According to Mackaness, only Merck's broad-spectrum product Primaxin was accepted by hospital formularies at a higher rate than Azactam. A more potent, second generation product, pirazmonam, is now under development as is an oral monobactam, tigemonam, which is currently in human testing. Squibb's liposome-formulated antifungal product Fungizone (amphotericin B), under development with the Liposome Company, should reach the clinic in 1988, Mackaness added.

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