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Executive Summary

Miles' Cipro I.V. (ciprofloxacin), the first parenteral broad- spectrum quinolone antibiotic available in the U.S., was accepted by 58.1% of hospital formularies in the first six months after approval, according to a survey of 200 hospitals by Hospital Research Associates. Cipro I.V. was approved in late December and formally launched in March ("The Pink Sheet" Feb. 4, T&G-1). Miles is promoting the advantages of "sequential therapy" using the new I.V. form followed by oral Cipro as an inducement to use the new dosage form and to protect market share of oral Cipro, which generated sales of $ 385 mil. last year in the product's fourth year on the U.S. market. Cipro is currently facing a competitive challenge so far from J&J's recently introduced oral quinolone Floxin (ofloxacin). J&J is claiming a higher bioavailability for its product compared to Cipro. Floxin also carries an indication for treating sexually transmitted diseases. However, as the second broad-spectrum quinolone on the market, Floxin has an uphill battle: the formulary acceptance rate for Floxin after three months on the market was 15.5% compared to 88% for oral Cipro during that product's initial launch, according to the HRA survey. Ortho also has filed an NDA for an I.V. dosage form of ofloxacin. Amgen's Neupogen (filgrastim) granulocyte-colony stimulating factor had the highest rate of formulary acceptance of the three CSF products launched in February and March of this year. It was carried by 20.4% of surveyed hospitals. Following Neupogen were Immunex' Leukine brand of granulocyte macrophage-colony stimulating factor (GM-CSF, or sargramostim) at 9.3% and Hoechst's GM-CSF brand Prokine at 7.8%. However, Neupogen use was restricted in 43% of the formularies carrying the product, which was almost double the restriction rate for Leukine (26%) and Prokine (20%), according to HRA. A high rate of restriction can "dramatically change the potential usage" of a product, HRA noted. Hospitals cite cost as one of the primary reasons for restricting use, the research firm said. Neupogen sales totaled $ 86 mil. from February through June; Leukine sales were $ 12.6 mil. for the three-and-a-half months ending in June. Glaxo's Zofran I.V. (ondansetron), for the treatment of chemotherapy-induced nausea and vomiting, is off to a fast start. The product, launched in February, had been added to 63.7% of hospital formularies by the end of June, according to HRA. HRA reported that hospitals added three times as many drugs to formularies than were deleted during the 12 months from June 1990 to June 1991. Fairfield, N.J.-based HRA surveys 200 hospitals each month to determine hospital formulary acceptance patterns for recently introduced drugs. Chart omitted.

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