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ABBOTT's NDA FOR CARTROL (CARTEOLOL) GIVES FIRM TWO CARDIOVASCULAR APPLICATIONS PENDING AT FDA AND AT LEAST SEVEN MDAs OVERALL; BAXTER EARNINGS, SALES OFF

Executive Summary

Abbott's NDA for the beta blocker Cartrol (carteolol) has been submitted to FDA, the firm noted in an Oct. 9 report on operations for the three and nine months ended Sept. 30. The application for the anti-angina/antihypertensive agent was submitted "last week," Abbott said. With Cartol, Abbott now has two NDAs in the cardiovascular field pending at FDA. Last year, Abbott noted in its annual report for 1983 that it submitted an NDA for Vasocard (terazosin), described as "a long acting second-generation vasodilator discovered by Abbott for use in hypertension." In the report, Abbott said it expected that Cartrol and Vasocard should come to market in 1985-86. The two products would build on the company's current U.S. cardiovascular product base of the potassium supplement K-Tab and the thrombolytic Abbokinase (urokinase). The Cartrol filing also gives Abbott at least seven NDAs overall which are pending at FDA. These include, in addition to the two cardiovascular products: two cephalosporins, one calcium replacement product, one benzodiazepine sedative/hypnotic, and the anticancer agent leuprolide (introduced in West Germany recently). For the third quarter, Abbott net income was up 14% to $91 mil., while volume inched ahead one percent to $731 mil., over the same period a year ago. Nine months sales by Abbott's pharmaceutical and nutritional products group, the firm said, were $1.22 bil., 5% ahead of the $1.16 bil. for the same period in 1983. Overall sales for the nine months were up 6% to $2.25 bil., from $2.13 bil., in the comparable period a year ago. Net earnings of $280 mil. were 16% above the $242 mil. for the first nine months in 1983, the company said. Baxter Travenol said that it has recently received FDA approval for two more premixed products packaged in the firm's MINI-BAG plastic containers. The approvals cover Merck's Mefoxin (cefoxitin sodium) and Fujisawa SmithKline's Cefizox (ceftizoxime sodium). However, the firm said that its results "continue to be negatively affected by declining hospital admissions in the U.S.," and that cost-containment efforts by the federal govt. and private payers are contributing to reduced sales and earnings. During the third quarter ended Sept. 30, Baxter Travenol net income of $39.7 mil. was off 30.8% from the same period a year ago, when net profit was $57.4 mil.Volume in the period was $465.9 mil., off 1.1% from $471 mil. last year. Chart omitted.

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