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Executive Summary

MILES ADALAT CC LAUNCH PRICE IS 26.5% DISCOUNT TO PROCARDIA XL for the 30 mg and 60 mg tablets, and 25% for the 90 mg tablet, according to the reported average wholesale price in the July Medi-Span Prescription Pricing Guide. The once-a-day nifedipine product was approved by FDA April 21. According to the Medi-Span notice, it is available in pharmacies as of July 1. The AWP for Adalat CC is $84.10 for 100 30 mg tablets, $145.50 for 100 60 mg tabs and $178.23 for 100 90 mg tablets, according to Medi-Span. Pfizer Procardia XL AWP for bottles of 100 tablets in 30, 60 and 90 mg strengths are $114.44, $198.01 and $237.63, respectively. Procardia XL U.S. sales in 1992 topped $1 bil. In a June 18 letter to pharmacy, Miles introduced Adalat CC as a source of "real value for real people with hypertension." The letter describes Adalat CC as offering "real economic value for patients" with "projected annual savings to your customers of 25% versus Procardia XL regardless of dose." The letter to pharmacists adds that Adalat CC offers "real retail value to you: Lower costs mean lower inventory investment and lower pricing. As a result, new prescription and refill rates for new Adalat CC should be high ...and in-store traffic should increase." "With these facts in mind, we are informing physicians of the real value of prescribing Adalat CC for once-daily nifedipine antihypertensive therapy," the letter states. Miles is "committed to a comprehensive promotional program that includes: Over 1,000 Miles representatives for high-impact detailing efforts; Comprehensive journal advertising and direct mail campaigns; Extensive convention activities; Nationwide public relations campaign; [and] Supportive educational programs." The letter adds that "the recommended initial inventory is one 100-count bottle each of the 30-mg and 60-mg extended-release tablets." Adalat CC is indicated for treatment of hypertension as a single agent or in combination with other antihypertensives. Procardia XL carries additional indications for vasospastic angina and chronic stable angina. Approved labeling describes Adalat CC as consisting of "an external coat and an internal core. Both contain nifedipine, the coat as a slow-release formulation and the core as a fast-release formulation." Procardia XL employs the Alza-developed GITS osmotic delivery system. The two delivery systems result in comparable bioavailability of nifedipine: Adalat CC is 84%-89% as bioavailable as immediate-release nifedipine, labeling states, while Procardia XL is 86% as bioavailable as the immediate-release drug. There appear to be differences in the pharmacokinetic profiles of the two drugs, however. Both produce blood levels with "decreased fluctuations" compared to immediate-release nifedipine. Adalat CC, however, reaches peak plasma concentrations at 2.5-5 hours, labeling states, "with a second small peak or shoulder evident at approximately 8-12 hours post-dose." Adalat CC labeling directs that the drug be taken on an empty stomach; Procardia XL labeling notes that the presence of food "slightly alters" pharmacokinetics, but no recommendation is made for fasted or fed dosing. The side-effect profiles of the two drugs appear to be similar. The most frequent side effect seen with Adalat CC in clinical trials was peripheral edema, followed by headache, flushing/heat sensation, dizziness, fatigue/asthenia, nausea and constipation. The same side effects are cited in Procardia XL labeling, with the exception of flushing/heat sensation. Because the GITS system employs a drug shell that does not dissolve in the body, Procardia XL labeling includes a precautionary statement not present in Adalat CC labeling about potential obstruction in patients with "severe gastrointestinal narrowing." In a placebo-controlled monotherapy trial in which 192 patients received drug, Adalat CC 30 mg produced a mean trough reduction in systolic/diastolic blood pressure of 5.3/2.9 mmHg; 60 mg produced a reduction of 8.0/4.1; and 90 mg tabs reduced blood pressure by 12.5/8.1, labeling states. In a placebo-controlled trial involving Adalat CC in combination with atenolol (233 treated patients), the three doses of Adalat CC reduced blood pressure by 7.8/3.8 mmHg, 10.1/5.3, and 10.2/5.8, labeling states. "Titration to doses above 90 mg daily is not recommended," labeling cautions. Procardia XL labeling recommends a ceiling of 120 mg. Pfizer has promoted Procardia XL for use in severe hypertension, suggesting that the higher maximum dose could shelter Procardia XL to some extent from Adalat CC competition. Miles filed an NDA for Adalat CC July 29, 1991. The drug was deemed "approvable" by FDA on Jan. 29 ("The Pink Sheet" April 5, T&G-7). Miles is also the licensee of Elan's once-a-day nifedipine product, Nifelan.

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