Progenics Regains Worldwide Rights to Wyeth's RELISTOR Franchise
Wed, 10/14/2009 - 4:46am
Progenics Pharmaceuticals, Inc. today announced that it 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 $10 million in six quarterly installments 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. -- 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 U.S. and the E.U. 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, M.D., Ph.D., 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." Strategies to maximize the value of the RELISTOR global franchise Progenics is pursuing a range of strategic alternatives to maximize the RELISTOR franchise, including: -- Licensing the RELISTOR franchise to a worldwide partner, with Progenics co-promoting the drug with its own sales force in the U.S. -- Commercializing the RELISTOR franchise in the U.S. on its own, and collaborating with one or more regional partners internationally. -- Forming strategic alliances with biopharmaceutical companies with marketed products or late-stage product candidates that are commercially compatible with RELISTOR. -- Forming a collaboration to assist with the development and commercialization of oral RELISTOR. Progenics to assume ongoing development of oral RELISTOR Progenics will assume immediate operational and financial responsibility for ongoing development of the oral form of RELISTOR. As part of the transition, Wyeth has agreed to provide certain assistance, expertise, and access to personnel to support Progenics' efforts. Two forms of oral RELISTOR have exhibited positive activity in recent clinical studies, and both were generally well tolerated. As part of the transition, Wyeth will provide certain quantities of one of these oral formulations for Progenics' use in clinical trials. Before announcing a clinical development plan for oral RELISTOR, Progenics is completing further non-clinical development work. Wyeth to continue to commercialize RELISTOR(R) (subcutaneous injection) during transition Wyeth will continue to commercialize RELISTOR through a transition period ending September 30, 2010 in the U.S. and December 31, 2010 internationally, subject to earlier termination by Progenics. During the transition period, Wyeth will be responsible for all ongoing commercial activities, including manufacturing, marketing, sales, distribution and customer service, and will book sales and pay royalties to Progenics. Wyeth will transfer responsibility for the manufacture and sale of RELISTOR (subcutaneous injection) to Progenics or its new partners at the end of these transition periods, or in the case of ex-U.S. markets, sooner, if applicable. Wyeth to support continued development of subcutaneous RELISTOR during transition Wyeth has agreed to complete, at its expense, several ongoing clinical studies of subcutaneous RELISTOR. As part of this commitment, Wyeth will complete the ongoing 1,000-patient, one-year phase 3, safety study designed to support Progenics' sNDA submission of RELISTOR to treat OIC in the chronic-pain patient population. In May 2009, Progenics and Wyeth reported a positive outcome from a 470-patient, phase 3 efficacy clinical trial in this patient population, which showed statistically significant improvements in the occurrence of bowel movements with the use of RELISTOR. Adverse events observed in this study were similar to those seen in prior studies. Results from this safety study, combined with results from the efficacy trial, are expected to be included in an sNDA submission to FDA by Progenics by early 2011. Wyeth will reimburse Progenics up to $9.5 million for development of a multi-dose pen for subcutaneous RELISTOR. Progenics plans to launch subcutaneous RELISTOR in this multi-dose pen for the chronic-pain OIC market in 2011. Wyeth will also provide up to $5 million in support for required pediatric studies. Progenics' agreement with Ono Pharmaceutical unaffected Today's announcement does not affect Progenics' development and commercialization agreement with Ono Pharmaceutical Co., Ltd. In October 2008, Progenics licensed to Ono the Japanese rights to the subcutaneous form of RELISTOR. Ono is responsible for developing subcutaneous RELISTOR in Japan, including conducting the required clinical trials, and will be responsible for commercialization in Japan upon development necessary to support regulatory marketing approval. Under the agreement, Progenics received an upfront fee, and is entitled to commercial and development milestones, as well as royalties on sales of RELISTOR in Japan.