SQUIBB HOPING FOR CAPOTEN APPROVAL IN MILD-TO-MODERATE CONGESTIVE HEART FAILURE BY LATE 1987/EARLY 1988; SALES IN 1987 EXPECTED TO TOP $700 MIL.

Capoten approval as second step therapy for congestive heart failure in place of digitalis could come as early as late 1987/early 1988, Squibb Senior VP-Corporate Affairs Joseph Stewart said at the Alex. Brown & Sons twelfth annual health care seminar in Baltimore on May 6. Stewart said Squibb filed for the mild to moderate congestive heart failure indication with FDA in December of last year. "We should have approval for the indication [by the] end of this year, middle of next year," he predicted. Squibb presented results from a large clinical study of Capoten versus digitalis as second step treatment after diuretics at the American College of Cardiology meeting in March. In the first year after approval, Stewart predicted that the expanded congestive heart failure indication would add over $100 mil. to Capoten annual sales. In five years after approval, the expanded indication could add over $200 mil. in sales annually, the Squibb exec projected. Capoten currently is the only ACE inhibitor to be approved for last resort treatment of congestive heart failure after diuretics and digitalis, with labeling for use in conjunction with both diuretics and digitalis. Merck reported last fall that it had resubmitted its filing in support of Vasotec heart failure labeling to FDA. In addition, Vasotec is being studied in a long term NIH/VHA congestive heart failure trial. Sales of Capoten continue to rise sharply, Steward noted, despite the competition from Merck. In the first quarter of 1987, worldwide Capoten/Capozide sales were up 50% to $158 mil. "We feel that in the case of 1987 that we are probably on track for volume around $700 mil., perhaps more," Stewart said. Sales of $700 mil. this year would represent a 35% increase over 1986 sales of $522 mil. The product's sharp growth is also reflected in the rate of prescribing in the U.S. Stewart said that as of March "Capoten total new Rxs and refill Rxs are running at the rate of 1 mil. Rxs or more per month. In 1986, Capoten Rxs in the U.S. reached 8.5 mil. First quarter Rxs approached 2.7 mil., the Squibb exec said. Capoten's refill ratio in recent months resembles a product in its early growth stage, Stewart observed, rather than a product approaching maturity. "Typically, when you see a mature cardiovascular product that ratio approaches 3 [refill Rxs for every new Rx]," Stewart explained. "As large as Capoten is, even given its present labeling and approved indications, the refill ratio [2.39 in January] indicates to me that there is a lot of juice left in that orange." New Rxs in the U.S. totaled 308,000 in March, he noted. The recently launched injectable antibiotic Azactam "could be a $60-80 mil. brand in 1987" depending on Squibb's success in getting it on formularies, Stewart predicted. As an indication of the potential success for Azactam in the U.S. market, Stewart pointed out that the product his approximately a 10% share of the Italian market -- the third largest antibiotic market after the U.S. and Japan. He said that sales of Azactam in Italy last year were "approximately $25-28 mil." In the first quarter, Squibb reported Azactam worldwide sales at $14 mil. Squibb has both an oral monobactam tegemonam and the second generation monobactam pirazmonam in clinicals. Squibb's second largest product in the next few years could be the nonionic imaging agent Isovue, Stewart indicated, surpassing Corgard. During 1986, Squibb created a specialized sales force to market diagnostics, enabling the company to win the leading share of the total U.S. contrast media market by year-end. Isovue's $45 mil. in first year sales helped Squibb take a 38% share of the U.S. market. Stewart projected Isovue sales for 1987 at $80-100 mil. Stewart also highlighted the performance of Squibb's wound management subsidiary Convatec. "It was a business that was started de novo in Squibb some ten years ago and from that point it has become a $162 mil. business," he noted. Among the subsidiary's development projects, Squibb is looking at combining several new topical steroids with its DuoDerm wound healing agent "to form something that will be even more efficacious," Stewart said.