Progenics Pharmaceuticals, Inc. develops medicines for oncology in the United States and internationally. The company's primary clinical-stage product candidates include Azedra, a radiotherapeutic product candidate, which is in Phase IIb clinical trial under special protocol assessment for the treatment of pheochromocytoma and paraganglioma; 1404, a technetium-99m labeled small molecule that has completed Phase II testing, as well as acts as an imaging agent to diagnose and detect prostate cancer; and PyL, a fluorinated prostate specific membrane antigen (PSMA)-targeted PET imaging agent for prostate cancer. Its clinical-stage product candidates also comprise 1095, a PSMA-targeted Iodine-131 labeled small radiopharmaceutical molecule for the treatment of metastatic castration resistant prostate cancer; PSMA antibody-drug conjugate, which has completed Phase II testing in chemotherapy-experienced patients and is ongoing second cohort in chemotherapy-nave patients for the treatment of prostate cancer; and EXINI Bone BSI, an analytical tool for analysis of bone scan index from bone scintigraphy images. The company also offers Relistor-subcutaneous injection for the treatment of opioid induced constipation (OIC) in advanced-illness patients receiving palliative care when laxative therapy has not been sufficient; and for treatment of OIC inpatients with non-cancer pain. In addition, it develops Relistor-oral that has completed Phase III testing for the treatment of OIC; and PRO 140, which is in Phase III testing for HIV treatment. The company has license agreement with Salix Pharmaceuticals, Inc. for the development and commercialization of Relistor worldwide; and with Amgen Fremont, Inc. to use its XenoMouse technology for generating human antibodies to PSMA, as well as has collaboration agreement with Seattle Genetics, Inc. Progenics Pharmaceuticals, Inc. was founded in 1986 and is based in Tarrytown, New York.
+21% pre market! Valeant Gets FDA OK for Anticonstipation Tablets Developed by Progenics by WSJ By Josh Beckerman July 19, 2016 8:32 p.m. ET Valeant Pharmaceuticals International Inc. has received U.S. Food and Drug Administration approval for Relistor tablets to treat opioid-induced constipation for patients with noncancer pain. An injectable form of Relistor, which was developed by Progenics Pharmaceuticals Inc., was approved in 2008. In 2011, Progenics licensed Relistor rights in most markets to Salix Pharmaceuticals Ltd., which was sold to Valeant in 2015 for $11.1 billion. Progenics shares rose 36% to $6.74 in after-hours trading. Valeant was up 4% to $24.50. Valeant expects to begin U.S. sales of Relistor tablets in the third quarter. Progenics previously said FDA approval would trigger a $50 million milestone payment. Relistor was the first commercial product for Tarrytown, N.Y.-based Progenics. In the first quarter, Relistor royalty income of $2.2 million provided the bulk of Progenics’ $2.5 million of revenue.
The FDA will review Azedra for use in patients with malignant pheochromocytoma and paraganglioma. There are 800 new cases of pheochromocytoma each year in the US (https://www.mskcc.org/cancer-care/types/adrenal-tumors/about/types/pheochromocytomas-paragangliomas). 90% of pheochromocytomas are benign tumors and won't spread beyond the adrenal gland. Not sure about the count of paragangliomas...a reading of this article seems it may be 10% of the frequency of pheochromocytomas? Paragangliomas are also called extra-adrenal pheochromocytomas and these terms are often used interchangeably. Overall, it has been estimated that approximately 10% of pheochromocytomas occur in an extra-adrenal location. Compared to adrenal pheochromocytomas, paragangliomas have a higher risk of being malignant or cancerous, as high as 40-50% in some studies. (http://endocrinediseases.org/adrenal/paraganglioma.shtml) ...so 80 malignant pheochromocytomas a year, and 80 paragangliomas a year? Very rare tumors indeed.
PGNX, +1.71% rose 1.7% after the company said the U.S. Food and Drug Administration has accepted for review its new drug application for Azedra in patients with rare neuroendocrine tumors.
