Antidepressant Safety Concerns Not Impacting Forest's SSRI Sales
This article was originally published in The Pink Sheet Daily
Executive Summary
Publicity surrounding the safety of antidepressants in adult and pediatric patients is not having an impact on Forest's sales of Lexapro and Celexa, President Kenneth Goodman said during a July 20 conference call
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Publicity surrounding the safety of antidepressants in adult and pediatric patients is not having an impact on Forest's sales of Lexapro and Celexa , President Kenneth Goodman said during a July 20 conference call. An analyst asked whether the company is seeing any negative market response to labeling changes among antidepressants citing a potential increased risk of suicide in patients taking certain selective serotonin reuptake inhibitors. "Not that we can see, and not that doctors are telling us and the market research that we're doing," Goodman responded. Neither Lexapro (escitalopram) nor Celexa (citalopram) is approved for use in pediatric patients. Lexapro sales totaled $363.9 mil. in the quarter, nearly doubling from $191 mil. a year ago. Celexa sales for the fiscal first quarter were down 8.3% to $261.1 mil. as Forest concentrates on moving patients to the Lexapro brand. FDA requested a class warning in antidepressant labeling about the possible link to suicidality earlier this year (1 (Also see "FDA Requests Antidepressant Labeling Add Warning On Suicidality" - Pink Sheet, 22 Mar, 2004.)). Most manufacturers have complied with the request; Pfizer is still negotiating labeling language for Zoloft. FDA's handling of the pediatric suicide warning is being investigated by House and Senate Committees (2 (Also see "Organon Submitting Remeron Pediatric Data To Congress" - Pink Sheet, 19 Jul, 2004.)). The publicity surrounding the issue reached a new level after New York Attorney General Eliot Spitzer filed suit against GlaxoSmithKline alleging that the company concealed negative Paxil data in pediatric patients while promoting positive results (3 (Also see "GSK Handling Of Paxil Data On Pediatric Use Is Subject Of N.Y. Lawsuit" - Pink Sheet, 2 Jun, 2004.)). Forest has received a request for information from Spitzer about off-label clinical trials for, or promotion of, its products. In the aftermath of the Paxil lawsuit, Forest put out a press release defending its own clinical data disclosure practices and responding to criticism that it had not been even-handed in the publication of Celexa data. During the investor call, Goodman defended Forest's clinical trial practices: "All of our data is out there, so I don't think there's really anything out there that hasn't been disclosed." Forest's marketing partner, Lundbeck, is attempting to have previously unpublished results from a negative European study on Celexa published in a medical journal. "They may or may not be successful," he said. The House Energy & Commerce/Oversight Subcommittee was scheduled to hold a hearing on the publication and disclosure of pediatric clinical trials July 20, but postponed the meeting due to a scheduling conflict (4 (Also see "House Subcommittee Postpones Pediatric Antidepressant Hearing" - Pink Sheet, 19 Jul, 2004.)). Goodman told investors the House hearing is likely to be postponed "at least until the fall." - Kate Rawson |