Salix Pharmaceuticals (NASDAQ:SLXP) is a step closer to bringing to the U.S. Food and Drug Administration a once-a-day pill version of injectable constipation drug Relistor.
The Raleigh pharmaceutical company released successful phase 3 clinical trial results for the oral version of the drug and Salix now plans to submit a New Drug Application for the compound in the middle of 2012. Salix licensed Relistor earlier this year from Tarrytown, New York company Progenics Pharmaceuticals (NASDAQ:PGNX) in a deal that paid Progenics $60 million up front and could lead to another $90 million upon reaching certain regulatory milestones. Progenics stands to gain up to $200 million in sales-based milestones for Relistor.
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Relistor is indicated for treating constipation in patients who have advanced illness and are receiving opioids as part of their palliative care. Opioid medications’ mechanism for fighting pain also affects the gastrointestinal tract, which in turn causes constipation. Opioids can result in constipation so debilitating that laxative treatments don’t work. Relistor counteracts the constipating effects of opioids on the GI tract without affecting their ability to relieve pain.
Relistor, in injectable form, was approved in the United States in 2008. Injectable Relistor is protected by patents until 2017. Before Salix acquired Relistor’s rights, the drug was marketed by Wyeth, now a part of Pfizer (NYSE:PFE). Relistor generated $16 million in 2010 sales. A pill version, which is easier to administer, should boost sales of the drug as a more patient-friendly formulation. Salix’s agreement with Progenics gives the Raleigh pharma rights to the drug worldwide, except for Japan, where Ono Pharmaceuticals holds Relistor’s rights.
