Merck Communicates With UK’s MHRA Over Zocor Switch
This article was originally published in The Tan Sheet
Executive Summary
Escalating discussions in the UK regarding a behind-the-counter switch for Merck's Zocor (simvastatin) may be playing a part in FDA's renewed interest in an OTC switch for Mevacor (lovastatin)in the U.S
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Escalating discussions in the UK regarding a behind-the-counter switch for Merck's Zocor (simvastatin) may be playing a part in FDA's renewed interest in an OTC switch for Mevacor (lovastatin)in the U.S. Phone discussions between Merck and officials from the Medicines & Healthcare products Regulatory Agency took place during the week of Jan. 19. Although the company would not comment on the details of its communication with MHRA, Merck discussed increasing support of a switch for both Zocor and Mevacor during a year-end earnings call Jan. 27. "Zocor is off patent in the UK and given its track record, the efficacy and the fact that so many people continue to be untreated, or under-treated, the UK authorities have been receptive, just as the FDA has...signaled an increased willingness to consider over-the-counter status for these kinds of products," Senior Director of Investor Relations Mark Stejbach said. Johnson & Johnson/Merck filed an application with MHRA to switch Zocor 10 mg behind-the-counter in mid-2003. A decision is expected by the summer. Issued last November, MIIRA's consultation document reviewing the application called the risk to benefit ratio of switching the drug "favorable" (1 (Also see "J&J/Merck Seeking Zocor Switch In UK; Mevacor Still Lead U.S. Candidate" - Pink Sheet, 24 Nov, 2003.), p. 3). Stejbach reiterated the company's current pursuit of a switch for Mevacor in the U.S., but made a clear distinction between the over-the-counter and prescription markets for statins in both countries. "It's quite clear for the person with very high levels of cholesterol, high risk factors, established heart disease, those people need to be under the care of a physician and on Zocor 40 mg, for example," he said. "But in the case of patients who don't go to the doctor, or self-medicate or go untreated or use over-the-counter or health food supplement kind of approaches...this is something that we, the medical community and health authorities are all agreeing...may be a better option," Stejbach noted. Zocor sales in the fourth quarter appeared to give Merck greater reason to switch the drug. International sales dropped 31% to $452 mil. compared to the prior-year period. Sales for the drug in the U.S. dropped 29% to $762 mil. Zocor declines for the full-year were not as steep, with foreign sales decreasing 17% to $1.87 bil. and domestic sales down only 1% to $3.14 bil. Overall, Zocor brought in $5.01 bil. in sales for 2003, an 8% decline compared to 2002. |