Salix Scores with Oral Relistor - Analyst Blog

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Salix Pharmaceuticals, Ltd. ( SLXP">SLXP ) and Progenics Pharmaceuticals, Inc. ( PGNX">PGNX ) recently received good news on the pipeline front with theiropioid-induced constipation (OIC ) treatment, oralRelistor (methylnaltrexone ) achieving its primary endpoints in a phase III study.

The 804-patient phase III trial was conducted to evaluate the safety and efficacy of oralRelistor for the treatment of (OIC ) in patients with chronic, non-cancer pain. Three once-daily dosing regimens of oralRelistor were evaluated: 150, 300 and450mg .

US Filing in Mid-2012


Highly statistically significant results were achieved for the primary endpoint in two of the three treatment arms compared to placebo. In addition to showing highly statistically significant improvements in rescue-free bowel movement (RFBM ) within 4 hours of administration over 28 days, the 300 and 450 mg arms also demonstrated highly statistically significant improvements inRFBM within 4 hours of administration following the first dose compared to placebo.

The 300 and 450 mg arms also achieved statistical significance for two key secondary efficacy endpoints. OralRelistor's safety profile was comparable to placebo. With these results in hand,Salix andProgenics intend to file for US Food and Drug Administration (FDA) approval for the oral formulation in mid-2012.

Relistor Deal Signed in Feb

Salix acquired worldwide (excluding Japan) rights toRelistor fromProgenics in February 2011.Relistor is already available as a subcutaneous injection for the treatment ofOIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.Relistor is approved in more than 50 countries including the US.Relistor sales came in at $16 million in 2010.

WhileSalix' s sales force started marketing the product in the US from April,Salix granted a license to Link Healthcare in October 2011 to marketRelistor in Australia, New Zealand, South Africa and Asia. The company is currently looking for a distribution partner in Europe.

Salix is looking to driveRelistor sales through label expansions and focused promotion efforts. While initial focus will be ongastroenterologists ,Salix intends to expandRelistor's use among primary care physicians eventually.Salix's presence in thegastroenterology space should increase awareness of the product.

Besides developing an oral formulation ofRelistor ,Salix filed a supplemental new drug application (sNDA ) seeking approval for the use ofRelistor in chronic non-cancer pain patients withOIC . A response should be out by April 27, 2012. According to the company,Relistor could achieve peak sales of $1 billion in the US provided the company gains approval for label expansions and the oral formulation.

Outperform onSalix

We currently have an Outperform recommendation onSalix , which carries aZacks #1 rank (short-term Strong Buy rating). We are encouraged by the positive data on oralRelistor . TheRelistor deal should help drive long-term growth atSalix .


 
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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: PGNX , SLXP

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