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Rifamycin Enrollment Commences
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Santarus, Inc. (SNTS - Snapshot Report) recently announced that it has started enrolling patients for its first phase III study with rifamycin SV MMX, which is being studied for the treatment of patients with traveler’s diarrhea.
The phase III multi-center, randomized, double-blind study, which will be conducted with approximately 300 patients, will assess the safety and efficacy of rifamycin SV MMX taken twice daily for three days versus placebo in the treatment of patients with travelers’ diarrhea. The study will seek to establish the superiority of rifamycin SV MMX over placebo.
The timely and successful completion of this study should allow Santarus to commence a second phase III study in the first half of 2011. Santarus is also exploring plans to develop rifamycin SV MMX for additional indications. An update should be available in the second half of 2010.
Santarus acquired exclusive rights to develop and commercialize rifamycin SV MMX from Cosmo Technologies Ltd. in December 2008. In addition to rifamycin SV MMX, Santarus in-licensed another late-stage pipeline candidate from Cosmo -- budesonide MMX.
Both products fit well with Santarus' gastrointestinal focus. Budesonide is being developed for the induction of remission of mild-to-moderate ulcerative colitis. Top-line phase III data on budesonide should be available in the July-August timeframe.
If developed successfully, Santarus should be in a position to file the new drug application (NDA) for budesonide MMX in the second half of 2011. Meanwhile, the NDA filing for rifamycin SV MMX should come in 2012.
Annual peak sales of budesonide MMX and rifamycin SV MMX could be in the range of $150 million - $250 million and $50 million - $150 million, respectively.
We currently have a Neutral recommendation on Santarus. We believe the company will seek to expand and diversify its product portfolio through in-licensing and product acquisition deals in order to help make up for the loss of revenues that will take place once Zegerid goes generic.
The phase III multi-center, randomized, double-blind study, which will be conducted with approximately 300 patients, will assess the safety and efficacy of rifamycin SV MMX taken twice daily for three days versus placebo in the treatment of patients with travelers’ diarrhea. The study will seek to establish the superiority of rifamycin SV MMX over placebo.
The timely and successful completion of this study should allow Santarus to commence a second phase III study in the first half of 2011. Santarus is also exploring plans to develop rifamycin SV MMX for additional indications. An update should be available in the second half of 2010.
Santarus acquired exclusive rights to develop and commercialize rifamycin SV MMX from Cosmo Technologies Ltd. in December 2008. In addition to rifamycin SV MMX, Santarus in-licensed another late-stage pipeline candidate from Cosmo -- budesonide MMX.
Both products fit well with Santarus' gastrointestinal focus. Budesonide is being developed for the induction of remission of mild-to-moderate ulcerative colitis. Top-line phase III data on budesonide should be available in the July-August timeframe.
If developed successfully, Santarus should be in a position to file the new drug application (NDA) for budesonide MMX in the second half of 2011. Meanwhile, the NDA filing for rifamycin SV MMX should come in 2012.
Annual peak sales of budesonide MMX and rifamycin SV MMX could be in the range of $150 million - $250 million and $50 million - $150 million, respectively.
We currently have a Neutral recommendation on Santarus. We believe the company will seek to expand and diversify its product portfolio through in-licensing and product acquisition deals in order to help make up for the loss of revenues that will take place once Zegerid goes generic.
Read the full analyst report on SNTS
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