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Final Decision from European Commission Expected by Mid-2008
COLLEGEVILLE, PA. and TARRYTOWN, NY, USA | April 24, 2008 | Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX), today announced that the companies have received a positive opinion for RELISTOR(TM) (methylnaltrexone bromide) subcutaneous injection from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA). The companies are seeking the approval of RELISTOR in Europe for the treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.
The CHMP is responsible for reviewing medicinal product applications for safety, quality and efficacy. The CHMP's positive opinion for RELISTOR will now be forwarded to the European Commission for a final decision, which is anticipated by mid-year.
RELISTOR, administered via subcutaneous injection, is a peripherally acting mu-opioid receptor antagonist that decreases the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain.
About the Subcutaneous RELISTOR Clinical Investigational Program
In March 2007, Progenics submitted a New Drug Application for subcutaneous RELISTOR for the treatment of opioid-induced constipation (OIC) in patients receiving palliative care to the U.S. Food and Drug Administration. This application has a Prescription Drug User Fee Act (PDUFA) date of April 30, 2008. In May 2007, Wyeth submitted a Marketing Authorization Application (MAA) in Europe to the European Medicines Agency (EMEA) for subcutaneous RELISTOR. The EMEA review is ongoing. In August 2007, Wyeth submitted a marketing application to the Therapeutic Goods Administration division of the Australian government for subcutaneous RELISTOR. On March 28, 2008, RELISTOR received approval from Canada for the treatment of opioid-induced constipation (OIC) in patients with advanced illness receiving palliative care.
About the Companies
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non- prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
Progenics Pharmaceuticals, Inc., of Tarrytown, NY, 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. Principal programs are directed toward gastroenterology as well as the treatment of HIV infection and cancer. The Company, in collaboration with Wyeth, is developing methylnaltrexone for the treatment of opioid-induced side effects, including constipation (oral and subcutaneous formulations) and postoperative ileus (intravenous formulation). In the area of HIV infection, the Company is developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody targeting the HIV entry co-receptor CCR5, which has completed phase 1b clinical studies with positive results. In the area of prostate cancer, the Company is developing a human monoclonal antibody drug conjugate - a selectively targeted cytotoxic antibody directed against prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells. Progenics is also developing vaccines designed to stimulate an immune response to PSMA.
SOURCE: Wyeth Pharmaceuticals
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