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MARION MERRELL DOW’s PENTASA AMONG THREE NDA SUBMISSIONS

Executive Summary

MARION MERRELL DOW's PENTASA AMONG THREE NDA SUBMISSIONS by the company in February, Chairman Joseph Temple, Jr. told the Alex. Brown health care conference May 8 in Baltimore. Pentasa (5-amino-salicylic acid), a treatment for ulcerative colitis, is licensed from the Danish firm, Ferring A.S. It is also being studied for Crohn's disease. Along with Pentasa, MMD submitted NDAs for once-a-day versions of Cardizem (diltiazem) and Seldane (terfenadine), Temple said. The company has previously said that it filed for a Seldane suspension during the first quarter. MMD reportedly filed a PMA (new device approval application) for its artificial skin product, Integra, with FDA at the beginning of May. The artificial skin is being developed by Marion's former Wound Care Division. The company is seeking a buyer for that business as one of its efforts to trim operations following the merger. Ulcerative colitis affects some 2 mil. persons in the U.S., Temple told the Alex. Brown meeting. Pentasa provides those patients with a sustained-release oral dosage form of treatment. "Estimates of maturity sales range from $20-$100 mil.," the MMD chairman said. Last year, Marion predicted that Pentasa would be approved before June of 1992. Cardizem QD is one of a broad range of spin-offs from the company's $590 mil. franchise drug. MMD has several line extensions for Cardizem, including Cardizem I.V., Cardizem b.i.d. and QD for angina and a diltiazem/hydrochlorothiazide combo product, Cardizide SR. The Cardizem I.V. NDA was submitted in October of last year, Temple said. He predicted the intravenous form would have sales of "around $80 mil., three years after approval." The NDA for the twice-a-day Cardizem for angina will be sent to FDA "before the end of this quarter," Temple said, with approval for the QD NDA targeted for the first quarter of 1992. The sustained-release diltiazem/diuretic combo Cardizide SR is set for filing with the FDA "early in the second half of 1990." The 1989 introduction of Cardizem SR produced $112 mil. in sales in its first 12 months on the market. That figure ran behind pre-launch estimates in the $200 mil. range made by Marion in the spring of 1989. In the first quarter of calendar 1990, the new sustained-release form did $38 mil., on top of sales of $140 mil. for the conventional-release product. Cardizem SR is competing in a touch class against Searle's Calan SR and Pfizer's Procardia XL (see box for MMD figures on formulary acceptance for Cardizem SR). Commenting on the prospects for a once-a-day prescription version of Seldane, Temple said "it answers the competitive advantage of other agents that are currently dosed once a day." Seldane once-daily results in Europe, Temple asserted, "demonstrate that we can compete with all of the new nonsedating antihistamine products that you have been hearing about." Seldane competitors include Janssen's Hismanal and cetirizine (UCB of Belgium's product licensed to Pfizer as Zyrtec) and Schering-Plough's pending product Claritin (loratadine). Temple maintained that MMD leads the drug industry in productivity per employee at $221,000 compared to the industry average of $148,000. Temple said the merged operations will continue to hold its position through staff reductions. "Sometime in 1990, we will see a reduction in the number of associates [Marion's term for employees] in the U.S. of about 400 without any layoffs....Over the next 12-15 months, you will continue to see a decrease in our population," Temple told the analysts, both in the U.S. and abroad. Carafate has received an "approvable" letter for the extended indication of prevention of duodenal ulcer recurrence. "We anticipate formal marketing approval soon," Temple said. The OTC version of the anti-ulcer drug sucralfate, under development with co-marketing partner Schering-Plough, is now targeted for an FDA submission for "the second half of next year," Temple said. The OTC switch product will be a tablet formulation. Also pending at FDA, Temple announced, is an NDA for Ditropan SR (oxybutynin chloride) for urge incontinence and bladder instability. The NDA for the product, which employs a new delivery system developed in Sweden, was submitted in August. Temple said: "We think that the total U.S. incontinence market is about $600 mil., with no truly effective SR product currently available to address the therapeutic need." CARDIZEM SR FORMULARY ACCEPTANCE RATES A Feb. 26 article in "The Pink Sheet" reported on formulary acceptance rate figures from a survey conducted by Hospital Research Associates. According to that survey, Cardizem SR had been accepted by 11% of hospital formularies after nine months on the market. A follow-up survey conducted for MMD by Market Dimensions in March and April of this year finds a formulary acceptance rate six times as great among a sample of teaching hospitals on the MMD call list. The following figures are from an "executive summary" of the findings of the Market Dimensions' study. * Cardizem SR is on formulary in 65% of 543 hospitals contacted. This level of formulary acceptance is virtually equal to Procardia XL, which was found to be on formulary in 69% of the hospitals. In a third of the hospitals where Cardizem SR is not on formulary, Cardizem SR has been ordered by the pharmacist within the past six months. Close to 70% of the hospitals do not have one calcium channel blocker identified as a preferred agent. Specialized outpatient hypertension clinics have been established by about a third of the hospitals. Virtually all of these clinics are covered by the same formulary as the hospital.
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