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FDA Sneezes at Claritin-Singulair Combo Pill

http://blogs.wsj.com/health/2008/04/28/fda-sneezes-at-claritin-singulair-combo-pill

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28-Apr-2008
by Sarah Rubenstein

A marriage between Schering-Plough’s Claritin and Merck’s Singulair allergy drugs doesn’t seem meant to be.

The companies said late Friday that the FDA had rejected an application for a pill that would combine the two drugs. Without explaining the FDA’s reasoning, they said they were “evaluating the agency’s response.”

The idea of a Singulair-Claritin combo had been resurrected after research from the two companies’ research several years back had failed to show the combination pill was better for seasonal allergy patients than the two pills administered separately. Recently, they made a pitch that the combined pill had an effect on congestion that wasn’t demonstrated with the individual components, the WSJ reported last year.

Wall Street wasn’t holding its breath waiting for this one. Sanford Bernstein analyst Timothy Anderson wrote in a note to investors this morning that the product mostly seemed interesting for Schering-Plough as a way to “get a cut” of Singulair. Claritin is already generic. However, both companies kept pretty quiet about the effort, so “the writing was on the wall that it would likely get turned down,” he wrote. Even if they companies had won over the FDA, the combo would have been competing in an allergy-treatment market chock full of generics and over-the-counter options.

Combo pills just aren’t causing a lot of happiness for Merck and Schering-Plough these days. The companies have been dealing with a firestorm over blockbuster combo pill Vytorin, which they market jointly. So we raised our eyebrow a bit upon reading a quote that Schering-Plough spokeswoman Lisa Ellen gave to Reuters after the Singulair-Claritin news came out: “We’re still looking at it, and still evaluating the future of the joint venture as well.” The comment inspired a headline on PharmaGossip that read, “Merck and Schering Plough — allergic to each other?”

We put in a call to Ellen, who explained that the respiratory joint venture is a separate entity from the JV that markets Vytorin. She said the quote was given in response to a question specifically about the respiratory joint venture.
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