AHP Protonix OTC Switch Considered As Long-Term Possibility
This article was originally published in The Tan Sheet
Executive Summary
American Home Products is interested in the Rx-to-OTC switch possibilities of its proton pump inhibitor Protonix but is unlikely to pursue nonprescription status for the drug in the near-term.
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American Home Products is interested in the Rx-to-OTC switch possibilities of its proton pump inhibitor Protonix but is unlikely to pursue nonprescription status for the drug in the near-term. The company addressed the current regulatory climate for switching new drug categories, such as the PPIs, during a second quarter conference call July 24. "We hope that more consideration for other categories will be made [by FDA] in the future," Senior VP-Global Consumer Health Care David Olivier stated. "It is the pipeline for self-medication but we haven't seen a great deal yet." Noting the company is not seeing signs of momentum building at the agency toward accepting PPIs as a consumer medicines category, he added that switch prospects at FDA currently are in "a quiet period...we see no indication of activity at the agency." AstraZeneca's attempt to switch its PPI Prilosec (omeprazole) for acute or episodic heartburn stalled during advisory committee review in late October (1 (Also see "Prilosec GERD Indication OTC Appropriateness Debated At NDAC Meeting" - Pink Sheet, 23 Oct, 2000.)and 2 (Also see "OTC Prilosec For Chronic Use Needs Explicit Labeling, NDAC, GDAC Advise" - Pink Sheet, 30 Oct, 2000.)). The Nonprescription and Gastrointestinal Drugs Advisory Committees found that Prilosec showed minimal efficacy for acute symptomatic heartburn relief, but possible benefits for long-term heartburn prevention, leaving the door open for a limited claim. Any OTC version of Prilosec would be marketed by Procter & Gamble. The consumer products giant recently predicted that an OTC version of the PPI would be available by July 2002. AHP's timeframe for pursuing a switch for Protonix (pantoprazole) clearly would be tied to the drug's patent, which is not set to expire until July 19, 2005. Protonix, which launched in May 2000, recorded second quarter sales of $132.1 mil., AHP noted. Among AHP's current OTCs, Advil enjoyed a solid second quarter, with U.S. sales advancing 11% to $111.9 mil. By comparison, McNeil Consumer Healthcare recently reported its second quarter sales for Tylenol and Motrin were adversely affected by competition from the prescription COX-2 inhibitors as well as a difficult comparison to last year's quarter, when Motrin Migraine Pain was introduced (3 (Also see "McNeil Supplements Nutritionals Portfolio With Viactiv" - Pink Sheet, 23 Jul, 2001.)). Whitehall-Robins' Robitussin franchise also performed well, with sales surging ahead 40.8% to $23.9 mil. Contributing to the gain were recent line extensions, such as Robitussin Allergy & Cough, the first allergy-indicated product in the line, which the firm introduced several months ago. Dimetapp revenues did not fare as well, dropping 8.1% to $9.2 mil. in the quarter. For the first half, sales for the brand grew 27.6%, boosted by a 50% gain in the first quarter. Rounding out a generally strong showing by its OTCs, Whitehall's Chap Stick brand recorded a 47% surge in sales to $20.9 mil. in the quarter and rose 32.9% to $49.7 mil. for the six months. The company's dietary supplements also had a good quarter, as Centrum rebounded from a sluggish first quarter with $94.7 mil. in sales (up 12.8%) while Caltrate revenues reached $17.7 mil. (up 25.5%). Solgar sales held relatively level in the quarter amidst the unfavorable climate in the U.S. supplement market. Although domestic sales were almost identical to the prior-year period at $17.9 mil., international revenues rose 4.5% to nearly $10 mil. Solgar attributed the steady performance to its product pipeline, noting it plans to continue introducing new products at an aggressive pace. The company recently extended its FemFocus collection and announced plans to revamp the line's packaging (4 (Also see "Solgar" - Pink Sheet, 18 Jun, 2001.)). Boosted by positive results nearly across the board, U.S. consumer health care sales gained 10.5% to $349.9 mil. Worldwide second quarter sales for the group were $522.5 mil., a 3.9% improvement over a year ago. Led by an 8% advance in pharmaceutical sales, AHP's overall net revenues increased 6.3% to $3.22 bil. for the quarter. Net earnings from continuing operations were up 16% to $477 mil. The company noted its earnings increased at a higher rate than sales due to the "combination of higher gross profit resulting from a favorable product mix of human pharmaceutical products and higher other income." |