Biotech Values

[DewDiligence]

FDA Rejects Claritin+Singulair Combo Pill

[It’s surprising when a simple combination of two long-established drugs for the same indication gets rejected, but that’s what happened here. I have no idea what the problem is. Claritin was approved by the FDA in 1993 and reached peak sales of $3B, becoming Schering-Plough’s largest-selling drug, before losing patent protection and going OTC in 2002. Singulair was approved by the FDA in 1998 and currently has annual sales of about $4.4B for Merck. Had the combination pill been approved, it would have been marketed by the 50/50 MRK-SGP JV that sells Zetia and Vytorin.]

http://biz.yahoo.com/prnews/080425/nyf067.html

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Schering-Plough/MERCK Pharmaceuticals Receives Not-Approvable Letter from FDA for Loratadine/Montelukast
Friday April 25, 8:59 pm ET

KENILWORTH and WHITEHOUSE STATION, N.J., April 25 /PRNewswire/ -- Schering-Plough/MERCK Pharmaceuticals (SPM) today confirmed that it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for a proposed fixed combination of loratadine and montelukast for the treatment of allergic rhinitis symptoms in patients who want relief from nasal congestion.

The New Drug Application filing for loratadine/montelukast was accepted by the FDA for standard review on August 26, 2007. The medicine is a single tablet that contains the active ingredients of CLARITIN ® (loratadine) and SINGULAIR® (montelukast sodium), both of which are indicated for the relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.

Schering-Plough/MERCK Pharmaceuticals is evaluating the agency's response.

The FDA decision does not impact the availability or continued use of CLARITIN or SINGULAIR.

About CLARITIN

Schering-Plough received U.S. Food and Drug Administration (FDA) approval on November 27, 2002, for the over-the-counter (OTC) sale of the original prescription strength of CLARITIN Tablets.

About SINGULAIR

SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis (SAR) in adults and children two years and older, and for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and children six months and older. In clinical studies for both SAR and PAR, SINGULAIR was generally well tolerated with a safety profile similar to that of placebo. Adverse events varied by age. The most commonly reported adverse events, occurring at a frequency of >1% and at an incidence greater than placebo, regardless of causality assessment, were sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, headache, otitis media, pharyngitis and increased ALT. SINGULAIR is contraindicated in patients with hypersensitivity to any of its components.
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