Perrigo New Product Program, Quality Control Back On Track In FY 2002
This article was originally published in The Tan Sheet
Executive Summary
Corrective actions taken in response to an unfavorable FDA inspection of Perrigo's Allegan, Mich. facility will preclude the planned November launch of minoxidil 5% and stall the company's pipeline, Perrigo told analysts in an Oct. 25 conference call.
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Corrective actions taken in response to an unfavorable FDA inspection of Perrigo's Allegan, Mich. facility will preclude the planned November launch of minoxidil 5% and stall the company's pipeline, Perrigo told analysts in an Oct. 25 conference call. The firm had hoped to introduce private label minoxidil 5% immediately following the Nov. 14 expiration of Pharmacia's exclusivity for Rogaine Extra Strength (1 (Also see "Leiner OTC Sales Buoy Company Performance As Supplement Market Slows" - Pink Sheet, 21 Aug, 2000.)). The private labeler expects its global action plan to reform the plant's quality control system and enable full resumption of new product development and releases by FY 2002, which begins July 1 of that year. FDA Detroit district investigators uncovered current Good Manufacturing Practices violations during a mid-year inspection that followed three recalls initiated this year (2 (Also see "Perrigo Extended-Release Acetaminophen Launch Delayed By QC Issues" - Pink Sheet, 11 Sep, 2000.)). Perrigo already had conceded it would have to postpone the introduction of extended-release acetaminophen (McNeil Consumer Healthcare's Tylenol Arthritis). However, the firm said the changes will not affect its plans to launch a honey-tussin cough syrup and new caplet forms of its supplement products in the near future. Perrigo noted the dearth of recent Rx-to-OTC switches also has hurt its pipeline, but added it is looking positively toward OTC approval for AstraZeneca/Procter & Gamble's Prilosec, Schering-Plough's Claritin, J&J/Merck's Mevacor and Bristol-Myers Squibb's Pravachol. Excluding the divested personal care division, Perrigo's net sales for the fiscal first quarter ended Sept. 30 were flat at $193.3 mil., compared to $194.5 mil. for the year-ago period. Prior-year Q1 sales including personal care were $212.3 mil. OTC sales improved roughly 2% in the quarter while nutritional sales declined about 12%, the firm stated. Net income rose 4.8% to $1.1 mil. Perrigo additionally has increased research and development spending 12.5% to $2.3 mil. in anticipation of the potential switches. During the quarter, Perrigo closed its Japan and Brazil offices, refocusing its international attention on Western Europe, primarily through growing retail customers such as Wal-Mart. |