Forest Takes "Wait And See" Approach On Effect Of Antidepressant "Black Box" Labeling
This article was originally published in The Pink Sheet Daily
Executive Summary
The company does not anticipate a "dramatic disruption" to the marketplace since the safety issues have been widely publicized, COO Goodman says. He suggests that the effect on Lexapro sales could mirror the temporary dip seen when the safety issues first surfaced last summer.
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Forest will take a "wait and see" approach to assessing the effect of "black box" class labeling for antidepressants. "It is still too early to accurately predict the growth for coming quarters as the market needs to absorb the coming black box warnings," Chief Operating Officer Kenneth Goodman said during the company's fiscal third quarter earnings call Jan. 18. FDA approved antidepressant "black box" class labeling regarding the potential risk of pediatric suicidality Jan. 12. The revised labeling should be on the products by Feb. 12 (1 (Also see "FDA Approves Antidepressant "Black Box" Class Labeling" - Pink Sheet, 13 Jan, 2005.)). Forest does not anticipate a large impact since the safety issues have been widely publicized. "I'm not necessarily expecting any dramatic disruption or change in the marketplace," Goodman said. "Everybody knows its coming." The company suggested that the effect on sales could mirror the temporary dip seen when the safety issues first surfaced over the summer. The question of "whether we'll see that again here in February, March and then come back to normal levels for next year or not, is really what we mean," Goodman said. Forest's Lexapro (escitalopram) sales grew sequentially by about 3% in the quarter despite the safety concerns with the antidepressant class. The product grew 14% in the fiscal second quarter (2 (Also see "Lexapro Shows Modest Sales Gains With Close Of 2004, Forest Says" - Pink Sheet, 5 Jan, 2005.)). Forest has made Lexapro the most heavily detailed product in the class due to market challenges from the launch of Lilly's antidepressant Cymbalta (duloxetine) and Forest's loss of exclusivity for Lexapro's predecessor, Celexa (3 (Also see "Forest Keeps Up Lexapro Detailing Pressure In Face Of Competition" - Pink Sheet, 10 Jan, 2005.)). Celexa (citalopram) saw sales for the quarter decline 53% to $130 mil. due to market entry of generic competition. The first five ANDAs for citalopram were approved Oct. 28, with additional generics approved thereafter (4 (Also see "Celexa Generics Clear FDA" - Pink Sheet, 28 Oct, 2004.)). - John Rancourt |