Targent Incorporated Reports Transfer of Orphan Drug Designations Relating to Isovorin -L-Leucovorin- for Colon Cancer Indication and for Osteosarcoma.PRINCETON, N.J. -- Targent Incorporated today announced 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. ) has authorized the transfer of two Orphan Drug Designations to its lead oncology candidate, Isovorin (L-leucovorin) for use in the treatment of colon cancer with 5- Fluorouracil and for use in conjunction with methotrexate for Osteosarcoma osteosarcoma /os·teo·sar·co·ma/ (os?te-o-sahr-ko´mah) a malignant primary neoplasm of bone composed of a malignant connective tissue stroma with evidence of malignant osteoid, bone, or cartilage formation; it is subclassified as . L-leucovorin is the 'active' isomer of the racemic racemic /ra·ce·mic/ (ra-se´mik) optically inactive, being composed of equal amounts of dextrorotatory and levorotatory isomers. ra·ce·mic adj. Abbr. leucovorin widely used today in many regimens containing 5-Fluorouracil in the treatment of a variety of malignancies. Isovorin is already on the market and extensively used in many EU countries and Japan preferentially to the racemic version. Supported by the FDA's 1992 Stereoisomeric Drug Development Policy, L-leucovorin theoretically is the preferred therapeutic enantiomer enantiomer /en·an·tio·mer/ (en-an´te-o?mer) one of a pair of compounds having a mirror image relationship. when compared with the marketed racemate racemate Mixture of equal quantities of two enantiomers, substances whose molecular structures are mirror images of one another (see isomer). The two enantiomers rotate polarized light through opposite angles, canceling each other out so that the racemic mixture has (d,l-leucovorin) in the US. With the successful transfer of the Orphan Drug Designations, Targent is working with the FDA on the L-leucovorin NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any re-submission. "We are pleased to receive the Orphan Drug designations and look forward to the continued clinical development of the active isomer for use in these serious malignancies," said Patrick Maguire, M.D., Ph.D., CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Targent Incorporated. About FDA Orphan Drug Designation Products designated as orphan drugs are those that are being developed to treat diseases affecting fewer than 200,000 people in the United States. The Orphan Drug Act guarantees seven years of market exclusivity to the first sponsor that obtains market approval for an orphan-designated product. Additional incentives for the sponsor include tax credits related to clinical trial expenses and a waiver from the FDA user fee for review of an application for the indication designated. About Targent Incorporated Headquartered in Princeton, Targent Incorporated (www.targent.com) is a privately held specialty pharmaceutical company focused on acquiring and developing late stage oncology compounds. |
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