Progenics Receives $40M Milestone Following FDA Approval of RELISTOR For OIC Patients With Chronic Non-Cancer Pain

Progenics Pharmaceuticals, Inc.

today received a $40 million milestone payment from its worldwide collaboration partner, Salix Pharmaceuticals, Ltd.

, upon the US Food and Drug Administration's approval last week of RELISTOR® Subcutaneous Injection for opioid-induced constipation in patients with chronic non-cancer pain. Progenics also provided additional information on its commercial arrangements with Salix for the expanded indication. "This new indication approval is a significant milestone for Progenics, creating the potential for additional revenue for the Company. While future commercial activity and development efforts are never guaranteed, today's milestone payment immediately strengthens our balance sheet, and the expanded indication could ultimately result in larger royalty and milestone revenues in the future," said Mark Baker, Chief Executive Officer of Progenics. "We will continue to work with Salix to advance regulatory efforts for RELISTOR in Europe, as well as to seek regulatory approval of an oral formulation of the drug, which has already completed a successful phase 3 clinical trial. And our ultimate Company-wide goal is to leverage RELISTOR success to build shareholder value, both through the efficient development of a high-value, oncology-focused pipeline and in exploring unique strategic opportunities, such as our acquisition of Molecular Insight last year." Under the 2011 Salix-Progenics collaboration, Progenics is also entitled to up to $50 million upon approval of an oral RELISTOR product in the U.S. Salix is also obligated to pay commercialization milestones of up to $200 million. The commercialization milestone payments range from $10 million when calendar-year U.S. net sales first exceed $100 million, to $75 million when such sales first exceed $1 billion. One or more, or all, commercialization milestones could become payable within the same calendar year if the specified sales levels are met. Progenics also receives royalties from Salix and its affiliates based on the following royalty scale: 15% on calendar-year worldwide net sales by Salix and its affiliates up to $100 million, 17% on the next $400 million of such sales, and 19% on such sales over $500 million. Progenics is also entitled to receive 60% of revenues received by Salix from ex-U.S. sublicensees of RELISTOR. Opioid analgesics are frequently prescribed for patients with chronic pain, including patients with advanced illness. An estimated 27 million patients in the US take opioids for chronic pain. Constipation is one of the most common and distressing side effects in patients receiving chronic opioid therapy. Approximately 40% of chronic pain patients, or nearly 11 million patients, receiving opioid therapy will experience OIC. RELISTOR is the first approved medication that specifically targets the underlying cause of OIC. RELISTOR is a peripherally acting mu opioid receptor antagonist (PAMORA) specifically designed to block the constipating effects of opioids in the gastrointestinal tract. The unique molecular structure of RELISTOR restricts it from crossing the blood-brain barrier and interfering with the analgesic effect of opioids. RELISTOR Subcutaneous Injection was approved in the United States in 2008 for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. The use of RELISTOR beyond four months has not been studied in the advanced illness population. The drug is also approved for use in over 50 countries worldwide, including the European Union, Canada, and Australia. In the 28 member countries of the EU, as well as Iceland, Norway and Liechtenstein, RELISTOR is approved for the treatment of OIC in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient. In Canada, the drug is approved for the treatment of OIC in patients with advanced illness, receiving palliative care. When response to laxatives has been insufficient, RELISTOR should be used as an adjunct therapy to induce a prompt bowel movement. Applications in additional countries are pending. RELISTOR is under license to Salix Pharmaceuticals, Inc. from Progenics Pharmaceuticals, Inc. For more information about RELISTOR, please visit www.RELISTOR.com