Salix Pharmaceuticals, Ltd.
) is facing a delay where the approval of two of its pipeline
candidates is concerned. The company and
) 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
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
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
PROGENICS PHARM (PGNX): Free Stock Analysis
SALIX PHARM-LTD (SLXP): Free Stock Analysis
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