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Executive Summary

Johnson & Johnson is entering 1991 with at least four new drug introductions planned and the possibility of a fifth before mid- year. J&J received a windfall in FDA's end-of-the-year rush with three late-year approvals: Ortho's oral quinolone antibiotic Floxin (ofloxacin); McNeil's calcium channel blocker Vascor (bepridil); and Ortho's Procrit (epoetin alfa). Plus, the company has further delayed the launch of Janssen's Duragesic fentanyl transdermal patch, approved in August 1990 for chronic pain in patients requiring opioid analgesia, until mid-year 1991 ("The Pink Sheet" Aug. 13, p. 11). An additional launch possibility during 1991 is the OTC vaginal antifungal Monistat, which is awaiting approval. The introductions for Procrit and Vascor are slated to begin "in the next several weeks," J&J said. On the scheduling of the Floxin launch, J&J would say only that the introduction will take place "in early 1991." The additional delay in the Duragesic launch, initially scheduled for January 1991, is due to several reasons, among them the time required to attain approval from the Drug Enforcement Administration as a Schedule II controlled substance and the requirement for FDA and DEA approval of annual production quotas for the product. Floxin was approved on Dec. 28 as a "1C" drug, a new molecular entity with little or no therapeutic gain over existing therapies. Floxin will be available in 200, 300 and 400 mg tablets. The new quinolone antibiotic is indicated for treatment of adults with lower respiratory tract infections, skin and skin structure infections, urinary tract infections, prostatitis, and sexually transmitted diseases. Floxin will compete against Miles' big-selling quinolone, Cipro, which generated U.S. sales of almost $ 385 mil. in 1990. Potential advantages Floxin may have over Cipro include better oral bioavailability. Floxin labeling notes that "the bioavailability of ofloxacin in the tablet formulation is approximately 98%." Labeling for Cipro states that "the absolute bioavailability is approximately 70% with no substantial loss by first pass metabolism." In addition, M. D. Anderson Cancer Center Director of Pharmacy-Patient Care Services Stephen Huber noted at a recent pharmacy meeting that Floxin may have "a slight advantage" over Cipro because of its longer half-life ("The Pink Sheet" Dec. 24, T&G-4). The clinical pharmacology section of Floxin labeling notes that "the effect that food has on the absorption of ofloxacin tablets has not been studied." In Floxin's approval letter, FDA points out that the company agreed to conduct "a Phase IV food interaction study." Food does not "substantially" affect Cipro's "overall absorption," the product's labeling says. Unlike Cipro, Floxin is indicated for treating sexually transmitted diseases such as "acute, uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae; nongonoccocal urethritis and cervicitis due to Chlamydia trachomatis; and mixed infections of the urethra and cervix due to Chlamydia trachomatis and Neisseria gonorrhoeoe. Cipro's labeling notes that the quinolone has shown to have in vitro activity against Neisseria gonorrhoeae and moderate susceptibility to Chlamydia trachomatis. The Miles drug, however, is also indicated for bone and bone structure infections -- indications that Floxin will not initially carry. Ortho licenses Floxin from Daiichi Seiyaku under a co- marketing agreement. The NDA had been pending at FDA since July 1987. McNeil's long wait for Vascor (bepridil) approval came to an end Dec. 28 when FDA approved the product as a last resort treatment for angina. The approval followed a seven-year FDA review and numerous ups and downs. The launch has been set for late January. The company would not disclose pricing. Vascor is indicated for treating "chronic stable angina (classic effort-associated angina)," the approved labeling states. FDA gave Vascor a "1-C" rating, denoting a new molecular entity with little or no therapeutic gain over existing therapies. Labeling notes that because the calcium channel blocker "has caused serious ventricular arrhythmias, including torsades de pointes type ventricular tachycardia, and the occurence of cases of agranulocytosis associated with its use, it should be reserved for patients who have failed to respond optimally to, or are intolerant of, other anti-anginal medication." The calcium channel blocker is expected to be co-marketed by McNeil and Carter-Wallace under the brandnames Vascor and Bepadin, respectively. Under a sublicensing agreement with Carter-Wallace, McNeil did the U.S. development work for bepridil. Carter-Wallace obtained U.S. marketing rights to the drug from Organon. Vascor's labeling notes that in controlled studies "with 200- 400 mg of Vascor, given as a once daily dose, exercise tolerance was improved and angina frequency and daily nitroglycerin use was reduced compared to placebo, improvement in exercise tolerance was dose related." Bepridil will be available in 200 mg, 300 mg, and 400 mg tablets. In another clinical study, bepridil "in doses of up to 400 mg/day, significantly improved exercise tolerance compared to diltiazem hydrochloride in patients refractory to diltiazem hydrochloride therapy." In one trial where Vascor (200-400 mg) was added to propranolol in daily doses of up to 240 mg, "there was an added effect of Vascor on exercise tolerance." The warnings section of Vascor's labeling states that the drug "has Class 1 anti-arrhythmic properties and, like other such drugs, can induce new arrhythmias, including VT/VF." The section also mentions the results of the Cardiac Arrhythmia Suppression Trial (CAST). In 1986, FDA's Cardio-Renal Drugs Advisory Committee voted not to recommend approval for Vascor as an anti-anginal agent because of safety concerns resulting from five sudden deaths in a study of patients with ventricular arrhythmia ("The Pink Sheet" March 31, 1986, p. 3). J&J had halted U.S. and U.K. clinicals in August 1985 following the deaths in France, where the drug is marketed. The company subsequently modified the arrhythmia trials to exclude patients with ischemic heart disease and/or premature ventricular conditions and resumed a study for the last resort indication in mid-1986.

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