The US Food and Drug Administration (FDA) recently informed
Salix Pharmaceuticals, Ltd.
) that it is still reviewing the company's new drug application
(NDA) for crofelemer (125 mg). Salix is looking to get crofelemer
approved for the symptomatic relief of diarrhea in HIV/AIDS
patients on anti-retroviral therapy (ART).
We note that earlier this year, the FDA had extended the review
period for crofelemer by three months to September 5, 2012.
Salix said that the agency is working with the company to
complete the review process. The main focus is currently on the
production and control of the active pharmaceutical ingredient for
crofelemer so as to ensure that the manufacturing and product
quality requirements of the Food, Drug & Cosmetic Act are
Salix now expects a final response from the FDA regarding the
crofelemer NDA in the first quarter of 2013.
Meanwhile, Salix and
) suffered a setback in late July 2012 in their label expansion
efforts for Relistor. Relistor is a subcutaneous injection 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.
Salix was looking to gain approval for the subcutaneous use of
Relistor for the treatment of OIC in adult patients with chronic,
non-cancer pain. However, the company received a complete response
letter (CRL) from the FDA in late July for this indication.
While the FDA has asked for additional data, we have low
visibility on whether the company will be required to conduct
additional studies. Salix is seeking an End-of-Review meeting with
the Division of Gastroenterology and Inborn Errors Products in
order to get a better understanding of the CRL.
Meanwhile, Salix has plans to bring an oral formulation of
Relistor to market. The company presented positive phase III data
and could file for FDA approval by September 2012.
We currently have a Neutral recommendation on Salix, which
carries a Zacks #3 Rank (short-term Hold rating). Xifaxan continues
to perform well and should keep driving growth. We believe Salix
will continue seeking suitable in-licensing opportunities in order
to grow revenues.
While pleased with the company's second quarter performance, we
were disappointed to see the FDA issue a CRL for Salix's sNDA for
Relistor. We currently have low visibility on the FDA's
requirements for this candidate and prefer to remain on the
sidelines until the company's meeting with the FDA regarding the
PROGENICS PHARM (PGNX): Free Stock Analysis
SALIX PHARM-LTD (SLXP): Free Stock Analysis
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