Molecular Insight Pharmaceuticals, Inc. Receives Orphan Drug Designation for Ultratrace(TM) MIBG for Treatment of Neuroendocrine Tumors
Posted on: Wednesday, 8 February 2006, 09:00 CST
Molecular Insight Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Ultratrace MIBG (iobenguane I 131) for the treatment of neuroendocrine tumors such as carcinoid, neuroblastoma, and pheochromocytoma. Ultratrace MIBG is a targeted radiopharmaceutical that is designed to maximize delivery of radiolabeled MIBG molecules so that neuroendocrine tumors can be effectively diagnosed and treated, and to minimize the amount of non-radioactive MIBG molecules that are delivered in the drug. The compound is currently in preclinical development and an Investigational New Drug application (IND) is currently under review at FDA.
Through the use of Molecular Insight's proprietary Ultratrace technology, Molecular Insight has created a platform to enable an ultrapure form of radiolabeled-MIBG. Ultratrace technology greatly reduces the amount of non-radioactive MIBG molecules, or cold contaminants, by several orders of magnitude, thereby enhancing tumor accumulation of therapeutic radiation.
With orphan drug designation, Ultratrace MIBG is eligible to receive up to seven years of exclusivity in the United States following marketing approval, as well as tax credits for research and development, protocol assistance, and reduced filing fees for marketing applications. Orphan drug designation is designed to facilitate the development of new therapies for rare diseases or conditions, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States. Additional criteria include the ability of a product to address a medical need where there are no other treatment options or to provide a significant benefit over other therapies.
About Molecular Insight Pharmaceuticals, Inc.
Molecular Insight Pharmaceuticals is a biopharmaceutical company focused on the research, development and commercialization of innovative molecular imaging pharmaceuticals and targeted radiotherapeutics. The company's product candidates target markets with significant unmet needs in cardiology, oncology, and neurology. Molecular Insight's lead product candidate, Zemiva(TM) (iodofiltic acid I 123) is in development as a molecular imaging pharmaceutical for the diagnosis of insufficient blood flow to the heart, or cardiac ischemia. The company's second lead product candidate, Ultratrace MIBG, is in development for the diagnosis and treatment of neuroendocrine tumors. Molecular Insight Pharmaceuticals is based in Cambridge, Massachusetts. The company's website is: www.molecularinsight.com.
Source: Business Wire
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