J&J Defends Duragesic, Ortho Evra Patches
This article was originally published in The Pink Sheet Daily
Executive Summary
Safety of transdermal delivery system is not undermined by recent reports of adverse events with the products, the firm says. Mylan defends its own transdermal fetanyl patch, stating that FDA safety review pertains to Duragesic.
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Johnson & Johnson is emphasizing the safety of its transdermal drug delivery systems in discussing adverse events linked to Duragesic (fentanyl) and Ortho Evra (norelgestromin/ethinyl estradiol). "We believe very firmly that in no way do these most recent discussions of Duragesic or Evra undermine the safety, efficacy and the utility of this drug delivery technology," CFO Bob Darretta stated during a second quarter earnings call July 19. The firm was asked to respond to an FDA Public Health Advisory and subsequent press reports concerning the safety of Duragesic and other fentanyl transdermal patches (1 (Also see "Duragesic Public Health Advisory Follows Palladone Withdrawal" - Pink Sheet, 15 Jul, 2005.)). The company also addressed a July 17 Associated Press article which stated that the firm's Ortho Evra patch may have contributed to the deaths of approximately 12 women in 2004 due to blood clots. VP-Investor Relations Helen Short noted "several inaccuracies" in the story, and said there were "no fatal events" linked to Evra during clinical trials for the product. "Our view is that there [are] no higher safety concerns with the use of a patch than there would be with oral administration," Darretta said. Regarding Duragesic, "our historical experience with the use of this product and its safety has been excellent, and we were caught somewhat by surprise by" FDA's investigation of fatalities that may be linked to use of the product, Daretta said. "We searched our database in terms of looking for any signal of a higher level of adverse events and we see no such signal in our database," the exec maintained. J&J is "anxious to have a dialogue with the FDA to see if there's anything that we can do to help with an issue we don't really understand very clearly," he stated. Darretta pointed out that 70% of the current pain patch category is occupied by generics. "Sometimes people are using the brand name to talk about the category when in fact the actual brand is now just under 30% of the volume." "I'm not suggesting for a moment that there's a problem with the generic products, but we just don't have enough information to draw any intelligent conclusions at this early stage," he concluded. Separately, Mylan defended the safety of its own transdermal fetanyl patch July 19 during its earnings call and in an accompanying press release. While the company "believes it has experienced a very small number of adverse events with our product, we are confident the adverse events are not associated with the quality of our product." "It is Mylan's understanding that the recent statements reported by the FDA regarding 120 deaths come from a review of the FDA's existing Adverse Events database pertaining to J&J's Duragesic," the firm said. FDA issued the advisory on fentanyl patches two days after the withdrawal of Purdue Pharma's Palladone (hydromorphone extended release) due to concerns about alcohol interactions (see 2 (Also see "OROS Hydromorphone Development Unaffected By Palladone Withdrawal, J&J Says" - Pink Sheet, 19 Jul, 2005.) ). - Daniel Healey |