Progenics And Wyeth Announce FDA Has Approved RELISTOR

Tarrytown, NY - Progenics Pharmaceuticals, Inc. and Wyeth Pharmaceuticals, a division of Wyeth , recently announced that the U.S. Food and Drug Administration (FDA) has approved RELISTOR (methylnaltrexone bromide) subcutaneous injection 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. In clinical studies, RELISTOR significantly decreased the constipating effects of opioids without interfering with pain relief. Wyeth expects to make RELISTOR available in the United States in early June.

"The approval of RELISTOR is a transformative event for Progenics Pharmaceuticals," says Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief Science Officer, Progenics Pharmaceuticals, Inc. "This is our first U.S. product approval. I am proud of what our Company has achieved and especially want to thank our patients and investigators who participated in the RELISTOR development program. This program has greatly benefited from our collaboration with Wyeth to develop and commercialize the RELISTOR platform of products."

Each year, more than 1.5 million Americans receive palliative care due to an advanced illness, such as incurable cancer, end-stage heart and lung disease, or AIDS. Many of these patients are prescribed opioids to manage their pain, and experts have stated that constipation that can be debilitating occurs in practically all of them.

"We are pleased to make RELISTOR available to patients to address this serious unmet medical need," says Bernard Poussot, President and Chief Executive Officer, Wyeth. "As Wyeth's third new medicine to receive FDA approval in 2008, RELISTOR is an excellent example of Wyeth's continuing commitment to develop and deliver medicines that work in novel ways and provide important new treatment options for patients."

Jay Thomas, M.D., Ph.D., an investigator in the subcutaneous RELISTOR clinical trial program and Clinical Medical Director of San Diego Hospice and the Institute of Palliative Medicine, says: "Opioid analgesics are the mainstay therapy for pain management in advanced-illness patients receiving palliative care. Side effects associated with opioids, such as constipation, can be severe enough to limit pain management. I am pleased that we now have a new treatment option to provide relief to advanced-illness patients with OIC."

SOURCE: Progenics Pharmaceuticals, Inc.