Marketed drug is also undergoing Phase III trials as oral therapy and in chronic pain patients.
Salix Pharmaceuticals is paying Progenics Pharmaceuticals $60 million up front for worldwide, ex-Japanese rights to the latter’s marketed Relistor® (methylnaltrexone bromide) treatment for opioid-induced constipation. Under terms of the deal, Progenics could receive up to another $90 million dependent on the achievement of certain U.S. regulatory milestones, plus sales-based milestones of up to $200 million, additional U.S. sales royalties, and 60% of revenues from non-U.S. sublicensees.
Salix has previously licensed Japanese rights to Relistor to Ono Pharmaceuticals. Ono started a Phase II trial evaluating the subcutaneous formulation of the drug in November 2010.
“Our partnership with Salix maximizes the global development, commercialization, and potential market of the Relistor franchise,” comments Paul J. Maddon, M.D., Progenics’ founder, CEO, and CSO. The firm’s president, Mark R. Baler, further suggested that the Salix deal represents “the culmination of our search for a partner with the skills, experience, and passion to effectively market and develop Relistor.”
Relistor subcutaneous injection is already approved in over 50 countries and netted worldwide sales of some $16 million in 2010, Progenics notes. The drug is a peripherally acting mu-opioid receptor antagonist indicated for the treatment of opioid-induced constipation in patients with advanced illnesses who are receiving palliative care and do not respond to laxative therapy. Relistor subcutaneous injection was first approved in the U.S. in 2008. During 2010, Relistor single-use, prefilled syringes were approved for use in the U.S., Canada, and the EU.
Phase III studies with subcutaneous Relistor are also ongoing for the treatment of opioid-induced constipation in chronic pain patients, and an sNDA submission for use of the drug among noncancer patients is planned for 2011. Phase III trials are separately evaluating an oral formulation of methylnaltrexone for the treatment of opioid-induced constipation.