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Executive Summary

Procter & Gamble Pharmaceuticals is being called upon to bolster Pfizer's detailing efforts for its antibiotic Zithromax (azithromycin). Under an "interim" agreement announced by P&G and Pfizer on Sept. 14, P&G's 400 pharmaceutical sales reps will begin this autumn to work with the Pfizer Labs sales staff of 700 already detailing Zithromax to U.S. pharmacists and physicians. P&G sales reps are being trained now, and the copromotion effort is set to begin "within the next few months," Pfizer said. P&G sales rep have experience dealing with the genitourinary market through Macrodantin and Macrobid (nitrofurantoin). Zithromax indications include use as a single-dose therapy for chlamydia. Additionally, under a proposed final version of the agreement, Procter & Gamble will copromote the broad-spectrum azalide antibiotic in "selected major European markets." The agreement is expected to be completed by "by early next year," Pfizer and P&G said. Zithromax is facing a tougher U.S. market. Since its approval on Nov. 1 last year, the product has had stiff competition from Abbott's Biaxin (clarithromycin), which was approved a day earlier and was launched in December, three months before Pfizer's drug. Pfizer voluntarily delayed the launch while FDA reviewed data on 19 serious events omitted from Zithromax NDA data ("The Pink Sheet" Jan. 6, T&G-2). Zithromax sales in the first six months of 1992 totaled $28 mil. Industry estimates put Biaxin 1992 sales between $30 mil. and $35 mil. as of April. At a July 30 meeting with analysts, Pfizer Chief Financial Officer Henry McKinell, PhD, maintained that sales figures for Zithromax have been muddied by the heavy use of physician samples and that physician awareness and usage figures for Biaxin and Zithromax were comparable ("The Pink Sheet" Aug. 3, p. 12). As of late April, Pfizer found a 56% physician awareness level for Biaxin and a 52% level for Zithromax. Usage figures were 66% for the Abbott product and 52% for Zithromax. McKinell indicated that Zithromax' once-daily dosing and short course of therapy for most indications would make sales figures particularly vulnerable to heavy sampling during the product's launch. According to a survey of 200 hospitals by Hospital Research Associates, through the first six months of 1992, Biaxin had a 46.5% acceptance rate in hospital formularies. Zithromax had a 17.3% formulary acceptance rate, the survey showed ("The Pink Sheet" Aug. 31, p. 13). The two antibiotics share indications for sinusitis, pneumonia, bronchitis and skin/skin structure infections. The Abbott drug, however, is a first-line therapy for strep throat, while Zithromax is labeled as second-line treatment for that indication ("The Pink Sheet" Nov. 11, 1991, p. 8). Zithromax offers once-daily dosing, while clarithromycin is given twice daily. In return for lending its marketing muscle to Zithromax, P&G gains access to the cardiovascular market via rights to Pfizer's Minipress line and gets help from Pfizer R&D with its second generation osteoporosis drug risedronate. Under the proposed final agreement, P&G will market Minipress and Minipress XL in the U.S. and Canada and the prazosin/polythiazide combination product Minizide only in the U.S. Minipress and Minizide both have lost market exclusivity in the U.S. only. Minipress XL was approved by FDA in January 1992 but has not been launched. Worldwide sales of the Minipress line were $141 mil. in 1991, a 14% decline from fiscal 1990, which followed a 23% drop for the previous year. Pfizer said sales have dropped an additional 12% worldwide in the first six months of this year. With the July 31 approval of Norvasc (amlodipine) and the best selling cardiovascular in the U.S. (Procardia XL) in its product line, Pfizer has a full plate of cardiovascular products without Minipress. The proposed agreement also calls for Pfizer to codevelop and copromote in the U.S. and major European markets P&G's risedronate, a drug candidate for the prevention and treatment of osteoporosis. Noting that the compound is in early Phase III trials, P&G said the deal contemplated that Pfizer will "take the lead" in the development process. Details of the trial design are still open and are being discussed with Pfizer. Risedronate is a follow-on to P&G's etidronate (Didronel) which is approved in the U.S. for the treatment of Paget's disease and heteroptic ossification, but not for osteoporosis. FDA's Endocrinologic & Metabolic Drugs Advisory Committee stopped short of recommending the drug for approval for that indication at a March 1991 meeting and requested that P&G perform studies to ensure etidronate's efficacy beyond two years ("The Pink Sheet" March 11, 1991, p. 3). Of concern was a study of third-year etidronate patients who showed a 50% increase in new vertebral fracture rates compared to placebo patients. P&G said it submitted additional clinical data this year. The drug will be called Didrocal in the U.S. if approved for the osteoporosis treatment. Acquiring a proven line of antihypertensives and copromoting a major new antibiotic is a shortcut to Procter & Gamble's stated goal of becoming a "major health care company." Other moves towards that goal include the company's only collaboration with a biotech company, a joint research agreement with Genta in October ("The Pink Sheet" Oct. 7, T&G-4), and changing the name of Norwich Eaton to Procter & Gamble Pharmaceuticals in April. The Pfizer agreement is P&G's only extant alliance with a major pharmaceutical firm in the prescription drug area. A 1987 agreement with Upjohn to develop an improved formulation of topical minoxidil was canceled. Procter & Gamble is a partner with Syntex for proposed marketing of an OTC Naprosyn (naproxen). The Procter & Gamble deal is Pfizer's second move in the osteoporosis treatment market in the last 18 months; Pfizer and Ligand Pharmaceuticals signed an R&D agreement focusing on osteoporosis treatments in May 1991.

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