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Executive Summary

Marion Labs expects its Cardizem volume to be split almost evenly between the currently marketed tablet form and the upcoming sustained release version by the end of the second year of marketing of the new formulation. The sustained release formulation of diltiazem (produced for Marion by the Elan Corporation) is still awaiting approval at FDA. Marion and Elan have been publicly anticipating approval for the new formulation since the end of last year ("The Pink Sheet" Nov. 2, T&G-1). "We think this product will be very, very important to us," Marion Senior Exec VP Jim McGraw told an April 13 meeting sponsored by Marion for drug wholesaler executives. The company forecasts "that probably within one to two years we will shift about 50% of the Cardizem tablet volume to the sustained release dosage form." Cardizem dollar volume is running at a pace that would generate about $ 480 mil. in the fiscal year ending this June. On a unit basis, the company estimates that between 1.5 bil. and 1.6 bil. Cardizem tablets are now being distributed on an annualized basis. Since December, the product has been generating about 1 mil. total Rxs per month in the U.S., up about 33% from the monthly average a year ago. The waiting period for FDA approval is creating a distribution challenge for the eventual product entry. Noting that the company has been building warehouse inventory for several months, McGraw warned that the initial shipments might have six-month expiration dates. Cardizem SR is a shellac type of sustained release product with tighter than normal tablet expiration dates. "When the product is approved," McGraw said, "it is going to require your full support again. What we plan to do is ship to you on your initial orders rather short-dated material -- it will have about six months dating." McGraw said that the company feels "that this is a manageable situation because we anticipate that this product will be utilized by the patients far before the expiration dating occurs." He reported that Marion has "considerable built-up demand for this sustained release dosage form: in both angina and hypertension patients." Because of final packaging requirements for Cardizem SR, the company anticipates a two-to-three week period between final FDA approval and first distribution. McGraw said the company still hopes for approval within the next three months, but he noted that he has been predicting an imminent approval since last January. "We are forecasting approval, hopefully sometime in my lifetime," he quipped. Marion will be offering wholesalers extended invoice dating on the first shipments of Cardizem SR. "In addition to your initial stocking," McGraw told the wholesalers, "we will give you an opportunity to rebuy more Cardizem SR with the original dating on it so that you will be able to make the maximum return." McGraw said the company will offer wholesalers 120 days extended dating from the date of invoice on the rebuy of the new product as well as the initial shipment. In addition to the hypertension indication for Cardizem, McGraw cited recent results relating to diltiazem's potential effectiveness against non-Q-wave reinfarctions. Referring to the 2,500-patient MDPIT (Multicenter Diltiazem Post-Infarction Trial) study results reported at the American College of Cardiology in late March, McGraw maintained that "to date, this is the only slow-channel blocker to demonstrate any value in reducing heart attacks." The MDPIT is coordinated out of the Rochester Medical Center. At a meeting with financial analysts in early March, Marion VP-Clinical Development Benjamin McGraw compared the results of the first two reinfarct trials with diltiazem to previous work with other calcium channel blockers. The Marion clinical development exec contended, for example, that "all of the nifedipine studies have been neutral or negative. Some people attribute this to its propensity to increase heart rate therefore oxygen demand." Previewing the MDPIT study in early March, Benjamin McGraw said "it showed some favorable effects in 80% of patients without pulmonary congestive (secondary congestive) heart failure." The clinical development exec pointed out that further work on the reinfarction benefits of channel blockers may be difficult. "We will probably never really know the full impact of the calcium channel blockers in the prevention of second heart attacks," McGraw said, "because it has now become basically ethically and administratively virtually impossible to run this trial." If other companies are precluded from seeking the reinfarction indication, Marion could be in the position to benefit from its relatively favorable early work. Product development work on Marion's two major gastrointestinal products, the Rx product Carafate (sucralfate) and the OTC Gaviscon, is headed toward suspension dosages. Senior VP McGraw told the wholesalers that the company expects that additional Carafate dosage forms will be approved within the next 12 to 15 months. "We anticipate," McGraw said, "first approval will be for the suspension form." A suspension form of Gaviscon Extra Strength Relief Formula is likely to be added in fiscal 1989. The new ESRD tablet formula has helped boost the sales of the Gaviscon line this year by 24% (in factory sales figures). The ESRD tablet was introduced in mid-October. The OTC line is headed for sales of about $ 30 mil. in this fiscal year and could reach $ 40 mil. in 1989.

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