Progenics Pharmaceuticals, Inc has entered into an agreement with Wyeth Pharmaceuticals, a division of Wyeth under which Progenics is regaining all worldwide rights to the Relistor franchise from Wyeth Pharmaceuticals, which Progenics had previously licensed to Wyeth Pharmaceuticals. Progenics will assume full control of future development and commercialization of subcutaneous Relistor after a one-year transition, and will immediately take over ongoing development of the oral form of the drug.
Under the terms of the transition agreement, Wyeth has agreed to pay Progenics a total of US$ 10 million in six quarterly instalments to cover certain costs associated with the transition; exclusively license to Progenics, on a royalty-free basis, its rights to Relistor intellectual property that arose under the companies' 2005 License and Co-Development Agreement; return to Progenics rights previously granted to it under the companies' 2005 Agreement.; and provide support by continuing manufacturing, marketing, sales, distribution, currently ongoing clinical studies and regulatory activities for subcutaneous Relistor.
Relistor (subcutaneous injection) is the only drug approved to treat opioid-induced constipation (OIC) in patients with advanced illness receiving palliative care. Relistor initially received marketing approval in Canada, the US and the EU in 2008 and is currently marketed in 30 countries. Additional launches of Relistor are planned throughout 2009 and 2010.
"Subcutaneous Relistor is a valuable product that is just beginning to realize its potential," said Paul J Maddon, Progenics' founder, chief executive officer and chief science officer. "We will aggressively continue development to expand the utility of both subcutaneous and oral Relistor into a new population: patients with chronic pain who experience opioid-induced constipation. We will be conducting registrational activities with many of our team members who were successful in submitting an NDA for the first approval of Relistor in the advanced-illness setting. If approved in the chronic-pain setting, we believe that Relistor can become the standard of care in OIC. Regaining the rights to Relistor is an important step toward our goal of becoming a commercial organization."
"Wyeth and Progenics mutually agreed that the return of rights to the Relistor franchise at this time was in the best interests of both companies," said Joseph M Mahady, president of Wyeth Pharmaceuticals and senior vice president of Wyeth. "Our collaboration enabled us to commercialize worldwide a first-in-class drug for an important unmet medical need. We plan to work closely with Progenics to ensure a smooth and successful transition."
Opioid analgesics are commonly prescribed to manage pain in patients with advanced illness. Constipation occurs in practically all palliative-care patients receiving opioid therapy for pain.
Relistor subcutaneous injection is approved in the United States for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.
Progenics Pharmaceuticals of Tarrytown, New York, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases.