Salix Faces Regulatory Delays - Analyst Blog


Salix Pharmaceuticals, Ltd. ( SLXP ) is facing a delay where the approval of two of its pipeline candidates is concerned. The company and Progenics Pharmaceuticals ( PGNX ) recently announced a three-month extension of the review period for their candidate, Relistor.

Salix and Progenics had filed a supplemental new drug application (sNDA) seeking approval for the use of Relistor in chronic non-cancer pain patients with opioid-induced constipation.

With the FDA extending the review period by three months, a response on Relistor's label expansion should be out by July 27, 2012. The FDA did not ask for additional studies.

Relistor is a subcutaneous injection that is currently approved for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.

The Relistor sNDA is not the only regulatory application facing a delay. Crofelemer, another of Salix' candidate, is facing a three month delay as well. The FDA said that it needs more time to review the Crofelemer new drug application (NDA) and will therefore issue a response by September 5, 2012 instead of June 5, 2012.

Salix is looking to get Crofelemer approved for the control and symptomatic relief of diarrhea in HIV/AIDS patients on anti-retroviral therapy (ART). The FDA did not ask for additional studies.

Neutral on Salix

We currently have a Neutral recommendation on Salix, which carries a Zacks #3 Rank (short-term 'Hold' rating). The delay in the FDA action dates for both candidates is disappointing. Salix will be reporting first quarter 2012 results after market close on May 7. According to the Zacks Consensus Estimate, the company is expected to post first quarter earnings of 54 cents per share on revenues of $168 million. The company has a record of surpassing expectations with an average earnings surprise of 34.78% in 2011.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

This article appears in: Investing , Business , Stocks

Referenced Stocks: ART , OIC , PGNX , SLXP

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