Feb 7 2011
Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) and Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP) today announced that they have entered into an exclusive worldwide (except Japan) agreement by which Salix has licensed rights to RELISTOR® (methylnaltrexone bromide). RELISTOR Subcutaneous Injection is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond 4 months has not been studied.
RELISTOR is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. The methylnaltrexone license includes intellectual property from the University of Chicago, Progenics Pharmaceuticals, and Wyeth Pharmaceuticals, including patents and applications with expiration dates that will range from 2017 through 2031. RELISTOR was approved in the United States in 2008, and currently the drug is approved for use in over 50 countries worldwide. In 2010, RELISTOR single-use, pre-filled syringes were approved for use in the United States, Canada and the European Union. Worldwide net sales of RELISTOR totaled $16 million in 2010.
Financial terms of the transaction include a $60 million up-front payment and development milestones totaling $90 million, contingent upon the achievement of certain U.S. regulatory milestones. Salix also will pay sales-based milestones of up to $200 million plus royalties on product sales in the U.S., as well as 60% of all revenue received from non-U.S. sublicensees. Salix will fund all development, registration and commercialization activities for RELISTOR in markets worldwide other than in Japan, where Progenics has licensed to Ono Pharmaceuticals the rights to develop and commercialize subcutaneous RELISTOR.
Commenting on the transaction, Mark R. Baker, President, Progenics, stated, "Our agreement with Salix represents the culmination of our search for a partner with the skills, experience and passion to effectively market and develop RELISTOR. With the strength of Salix's sales force and development team behind this product, I believe that RELISTOR's full potential can be achieved -- to the benefit of OIC patients."
"Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive and Chief Science Officer, Progenics, stated, "Our partnership with Salix maximizes the global development, commercialization and market potential of the RELISTOR franchise. Progenics and Salix share a vision of expanding the use of this important therapy among the millions of patients who suffer from the debilitating side effects of opioid pain medications."
Carolyn Logan, President and CEO, Salix, stated, "Constipation is a common, and often debilitating, gastrointestinal consequence of the use of opioid analgesics to manage pain. We are pleased to add RELISTOR Subcutaneous Injection, a first-in-class treatment for OIC in advanced illness, to our product portfolio. We believe RELISTOR represents a valuable asset that merits additional development and targeted commercialization. Currently an oral formulation of RELISTOR is in phase 3 development to potentially address OIC in patients with chronic, non-cancer pain. We look forward to utilizing our specialty sales force in the United States and our existing business partners worldwide to provide physicians with a solution to address the opioid-induced constipation experienced by their patients."
Salix will market RELISTOR directly through its specialty sales force in the U.S., and outside the U.S., RELISTOR will be marketed with sublicenses to regional companies. The parties plan an April 2011 transition of RELISTOR commercial and development responsibility to Salix from Pfizer Inc, which acquired Progenics' former RELISTOR partner, Wyeth Pharmaceuticals. While Salix effects a country-by-country transition of ex-U.S. commercialization rights, Wyeth will remain the Marketing Authorization Holder for RELISTOR and will continue to supply product. In the interim, Wyeth remains responsible for all manufacturing, clinical, medical and regulatory activities for RELISTOR outside of the U.S. and Japan.
Progenics Pharmaceuticals, Inc., and Salix Pharmaceuticals, Ltd.,