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