Merck may seek a OTC switch of its best-selling Singulair prescription medication, asking for a nonprescription indication for allergic rhinitis.
In addition to acknowledging it is considering applying to switch Singulair, which also is indicated for allergic rhinitis, Merck says it looks to expand its consumer health business as the closing of its Schering-Plough acquisition approaches.
During Merck's July 21 earnings call, executive VP Ken Frazier said the firm is not ready to declare a strategy for a Singulair switch, but he disclosed that Merck is examining the issue seriously in part because of the product's August 2012 patent expiry.
“We’re not in a position today to declare where we see Singulair OTC being, but it’s something we are looking at very carefully. It is a brand that’s had broad acceptance for allergic rhinitis and asthma. We believe it is a safe, effective product,” said Frazier, who is also president of Merck’s Global Human Health division.
“So that’s something that we will evaluate along with the FDA and others to decide … the best way to bring that forward in the context of OTC.”
While Singulair has FDA approval for treating asthmas as well as allergic rhinitis, Merck likely would seek a switch as an allergy product given the difficulty of gaining the agency's approval for a nonprescription asthma product.
Singulair generated $4.3 billion in sales in 2008 and accounted for 22 percent of Merck's overall revenue in the firm's fiscal 2009 second quarter. The firm said ther product's sales increased 16 percent to $1.3 billion during the quarter.
The Wall Street Journal's Health Blog covered Merck's OTC business plans here.
Although Singulair's OTC switch application would likely be as an allergy treatment, a nonprescription montelukas product would have potential attraction to consumers for treating asthma. Current OTC treatments for asthma are limited to epinephrine sprays and ephedrine-containing drugs, but health care professionals commonly caution patients against using those products because of their comparatively weak efficacy and possible side effects.
Additionally, sales of nonprescription ephedrine products are limited under federal and state laws enacted to prevent illicit methamphetamine production; and epinephrine inhalers must be removed from the market by the end of 2011 under an FDA rule amending the agency's regulation on the use of ozone-depleting substances in self-pressurized containers, as "The Tan Sheet" reported here.
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- Malcolm Spicer (firstname.lastname@example.org)