Progenics Pharmaceuticals, Inc. develops medicines for oncology. The company’s clinical development activities center on late-stage oncology assets. Its candidates target prostate specific membrane antigen (PSMA). Oncology The company’s principal clinical-stage product candidates in oncology are as follows: PSMA ADC is a fully human monoclonal antibody-drug conjugate designed to deliver a chemotherapeutic agent to cancer cells by targeting the three-dimensional structure of the PSMA protein. In a phase 2 open-label, multicenter clinical trial to assess anti-tumor activity, tolerability and safety, the company has completed enrollment in an original cohort of chemotherapy refractory patients with metastatic castration-resistant prostate cancer (mCRPC) and are conducting a second cohort of chemotherapy-naïve patients. 1404 (trofolastat) is a radio-labeled small molecule which binds PSMA and acts as an imaging agent to diagnose and detect prostate cancer, including metastases in other soft tissue and bone. The company has completed a global multicentered phase 2 study assessing the diagnostic accuracy of 1404 imaging in men with high-risk prostate cancer scheduled for radical prostectomy. Azedra is a phase 2 radiotherapeutic product candidate in development as a treatment for pheochromocytoma -- rare tumors found primarily in the adrenal glands – and related paraganglioma tumors occurring in other tissues. Azedra has Orphan Drug designation and Fast Track status in the U.S. for pheochromocytoma and paraganglioma, with clinical study conducted under a 2009 Special Protocol Assessment (SPA) with the FDA. Relistor Relistor is the first approved treatment for opioid-induced constipation (OIC) that addresses its underlying mechanism, decreases the constipating side effects induced by opioid pain medications such as morphine and codeine without diminishing their ability to relieve pain. Relistor subcutaneous injection is approved for sale in the U.S., E.U., Canada, Australia and elsewhere in pre-filled syringes, which are designed to ease preparation and administration for patients and caregivers. Under its License Agreement, Salix Pharmaceuticals (Salix) is responsible for developing and commercializing Relistor, including completing clinical development necessary to support regulatory marketing approvals for potential new indications (such as OIC in patients with chronic, non-cancer pain) and formulations of the drug (such as an oral formulation of methylnaltrexone, the active ingredient in Relistor). License and Other Agreements Oncology: The company’s PSMA Development Company LLC subsidiary has a collaboration agreement with Seattle Genetics, Inc. (SGI) under which SGI has granted the company an exclusive worldwide license to its proprietary ADC technology. Relistor: Under its License Agreement, Salix Pharmaceuticals is responsible for further developing and commercializing subcutaneous Relistor worldwide other than Japan, including completing clinical development necessary to support regulatory marketing approvals for potential new indications and formulations, and marketing and selling the product. Patents and Proprietary Technology The company seeks U.S. patent protection for its inventions, and files patent applications in Canada, Japan, European countries that are party to the European Patent Convention and other countries on a selective basis in order to protect inventions the company considers to be important to the development of business in those areas. Regulations The company and its product candidates are subject to regulation by the U.S. Food and Drug Administration and comparable authorities in other countries. In addition to regulations enforced by the U.S. Food and Drug Administration, the company is also subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and various other federal, state, or local regulations. History Progenics Pharmaceuticals, Inc. was founded in 1986.
(PGNX:Consolidated Issue Listed on NASDAQ Global Select )
777 Old Saw Mill River Road
Tarrytown, NY 10591
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