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MARION CARDIZEM APPROVAL FOR HYPERTENSION AND B.I.D. FORMULATION EXPECTED IMMINENTLY; CARDIZEM FISCAL 1988 SALES PROJECTED AT $ 500 MIL.

Executive Summary

FDA approval of a hypertension indication for Cardizem (diltiazem) and a b.i.d. sustained-release version of the calcium channel blocker could come imminently, Marion Chief Operating Officer James McGraw indicated at a Hambrecht & Quist healthcare conference in San Francisco Jan. 11-13. "We anticipate approval for hypertension and the sustained release dosage form in the very, very near future," McGraw said. "We have essentially completed the review process with the FDA. The only thing that remains is for them to write a letter, and we open up our mail every day," McGraw added. Marion has had a full NDA for the hypertension indication pending at the agency since May 1985 and a supplemental application for the b.i.d. formulation pending since the spring of 1985. Marion licenses the the twice-daily delivery system from Elan. Cardizem sales are expected to be "in the half billion dollar range" in fiscal 1988 (year ended June 30), McGraw reported. Cardizem did approximately $ 350 mil. in sales in 1987. The company attributes the expected 40-plus percent growth in sales to increases in prescriptions and to higher prices for the new 90 mg and 120 mg strengths of Cardizem. "Last May, we introduced a 90 and 120 mg strength form of Cardizem," McGraw noted. "Therefore, when we look at new and total prescriptions [dispensed], the dollar value per prescription has increased rather substantially." Leschly called the co-promotion "a natural" for Squibb. He noted that McNeil is strong in the general practitioner/family practitioner segment of the market. Squibb has 1,200 detailmen selling Capoten currently, Leschly said. McNeil will add another 400 sales representatives. The combined forces, Leschly said, will be able to match the increased competition, including the lisinopril launches by Merck and Stuart. Despite the dual competition from two ACE products and two companies, Squibb expects to dominate detailing in the ACE category. In fact, Squibb believes that captopril products will get one quarter of the total detailing time for the six top "high growth" products in the hypertension/congestive heart failure class (enalapril, lisinopril, atenolol, verapamil-SR, diltiazem and captopril). Leschly said that captopril got 22% of the detailing time in 1987 and that figure will increase to 25% in 1988. The primary growth for captopril, Leschly predicted, will come from switches from older hypertensive agents, beta blockers and diuretics. "We are fully aware of the increased competition that we have from ACE inhibitors as well as from the calcium blockers with the new hypertension indication," Leschly observed. "Therefore, our focus . . . is obviously to focus on the three areas where prescriptions are being switched from synthetic hypertensives to beta blockers and from diuretics to the calcium channel blockers and ACE inhibitors. The focus there is obvious because the potential is enormous." The ACE inhibitors commanded almost 30% of the French hypertension/congestive heart failure market in the third quarter of 1987. Leschly cited that figure in comparison to the 13.5% marketshare in the U.S. as an indication of the growth potential for ACE inhibitors at the expense of other drug treatments. "We have not penetrated the U.S. market yet, at all, compared to Italy and France," Leschly maintained. Leschly downplayed the head-to-head competition with enalapril. The marketshare figures shown by Squibb, however, indicate that the captopril products increased in share from 7% in the fourth quarter of 1986 to 7.9% in the second quarter of 1987. The products held steady at that level in the third quarter. Enalapril came up from 3.9% in the fourth quarter of 1986 to 5.6% in the third quarter of 1987. "Captopril is today the fourth biggest product of all [drug] products in the world, after Tagamet, Zantac and Adalat," Leschly said. "In the world market of hypertension/congestive heart failure, the $ 7.5 bil. market, we have achieved a marketshare of 9.5% in the third quarter of 1987, up from 8.6 in the fourth quarter of 1986. From the $ 775 mil. estimated total sales in the just-completed year, Squibb expects captopril to grow worldwide by between 25-30% in 1988. "Our objective of having a $ 1 bil. product in 1988 seems achievable," Leschly declared. In 1987, captopril grew 46% from $ 522 mil.
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