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ARTICLE | Company News

Salix appealing Relistor complete response

May 10, 2013 1:12 AM UTC

Salix Pharmaceuticals Inc. (NASDAQ:SLXP) disclosed in its post-market 1Q13 earnings that it submitted an appeal to FDA for a July 2012 complete response letter for an sNDA for subcutaneous Relistor methylnaltrexone to treat opioid-induced constipation (OIC) in patients with non-cancer pain. Salix said FDA requested additional clinical data, but the company believes existing data are sufficient for approval. Relistor is already approved in more than 50 countries, including the U.S., to treat OIC in patients receiving palliative care when response to laxative therapy has not been sufficient. Salix has worldwide rights to the peripheral mu opioid receptor ( OPRM1; MOR) antagonist from Progenics Pharmaceuticals Inc. (NASDAQ:PGNX), which was off $0.17 to $4.30 on Thursday (see BioCentury Extra, July 30, 2012).

Salix reported 1Q13 revenue of $202.6 million, up 18% from $171.1 million in 1Q12 but just shy of the Street's $205.9 million estimate. The company reported non-GAAP diluted EPS of $0.63, up from $0.46 in the prior year's quarter. The Street was expecting $0.68. The company reiterated its 2013 revenue guidance of $920 million and EPS guidance of $3.37. The Street is expecting EPS of $3.36 on full year revenues of $917.9 million. ...