Molecular Insight Pharmaceuticals, Inc. Acquires Clinical Stage, Targeted Radiotherapeutic Candidate Onalta(TM) (Formerly OctreoTher(TM)).Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the in Development for Treatment of Neuroendocrine Tumors CAMBRIDGE, Mass. -- Molecular Insight Pharmaceuticals, Inc. announced today that it has entered into a worldwide, exclusive licensing agreement with Novartis Pharma AG to develop and sell Onalta (previously known as OctreoTher or Y-90 SMT-487). Onalta, which has been studied in several clinical trials in the United States, is a radiolabeled peptide that the company intends to develop for the treatment of metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. pancreatic neuroendocrine neuroendocrine /neu·ro·en·do·crine/ (-en´do-krin) pertaining to neural and endocrine influence, and particularly to the interaction between the nervous and endocrine systems. neu·ro·en·do·crine adj. and carcinoid carcinoid /car·ci·noid/ (kahr´si-noid) a yellow circumscribed tumor arising from enterochromaffin cells, usually in the gastrointestinal tract; the term is sometimes used to refer specifically to the gastrointestinal tumor tumors in patients whose symptoms are not controlled by somatostatin Somatostatin A naturally occurring regulatory peptide that carries out numerous functions in the human body, including the inhibition of growth hormone secretion from the anterior pituitary gland. analogue therapy. Onalta is intended to complement Azedra(TM), Molecular Insight's other clinical stage radiotherapeutic candidate for the treatment of neuroendocrine tumors. Under terms of the agreement, Molecular Insight Pharmaceuticals will pay Novartis a licensing fee and additional payments upon completion of certain regulatory milestones, with royalties payable to Novartis upon commercialization of Onalta. Further terms of the agreement were not disclosed. Neuroendocrine tumors are a type of cancer that arises from neuroendocrine cells and can occur in different parts of the body. Previously, Novartis conducted Phase 1 and Phase 2 clinical trials with this compound in more than 300 patients. Onalta has been designated as an Orphan Drug by the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). Molecular Insight plans to develop Onalta as a treatment for metastatic pancreatic neuroendocrine and carcinoid tumors in patients whose symptoms are not controlled by current somatostatin analogue therapy. A somatostatin analogue is a synthetic compound, in this case a peptide, which functions in the body in a manner similar to the hormone somatostatin, which regulates a variety of other metabolic hormonal functions. Molecular Insight will assume sponsorship of the Investigational New Drug (IND) application that Novartis has filed with the FDA and the company is in discussions with the agency on the clinical trial protocol A Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in and path to approval for Onalta. Onalta joins Azedra (Ultratrace[TM] MIBG MIBG Metaiodobenzylguanidine ) as part of Molecular Insight's pipeline of targeted radiotherapeutic drug candidates in oncology. In June 2006, the company began a Phase 1 trial to evaluate the safety, tolerability and distribution of Azedra in adult patients with one of two forms of neuroendocrine cancer - either carcinoid or pheochromocytoma Pheochromocytoma Definition Pheochromocytoma is a tumor of special cells (called chromaffin cells), most often found in the middle of the adrenal gland. . About Molecular Insight Pharmaceuticals, Inc. Molecular Insight Pharmaceuticals is a biopharmaceutical company specializing in the emerging field of molecular medicine, applying advancements in the identification and targeting of disease at the molecular level to advance patient healthcare by addressing significant unmet needs. The company is focused on discovering, developing and commercializing innovative and targeted radiotherapeutics and molecular imaging pharmaceuticals with initial applications in the areas of oncology and cardiology. Molecular Insight's lead radiotherapeutic product candidates, Azedra and Onalta, are in development for the treatment of cancer. The company's lead molecular imaging pharmaceutical product candidate, Zemiva(TM) (iodofiltic acid I 123), is in development for the detection of cardiac ischemia, or insufficient blood flow to the heart. Molecular Insight Pharmaceuticals is based in Cambridge, Massachusetts. The company's website is: www.molecularinsight.com. |
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