Genzyme updates timeframe for acquisition of ILEX Oncology; completes Phase 4 Fabrazyme study.Genzyme Corporation, Cambridge, MA, and ILEX Ilex a bush bearing berries containing saponins; cause vomiting, diarrhea. Called also holly. Oncology, San Antonio, TX, announced the company is continuing to have product discussions with the US Federal Trade Commission (FTC FTC See Federal Trade Commission (FTC). ) regarding its planned merger. The companies say they expect the transaction to close in the 4th quarter of this year. Genzyme says it is working closely with the FTC to resolve outstanding issues regarding a proposed consent decree A settlement of a lawsuit or criminal case in which a person or company agrees to take specific actions without admitting fault or guilt for the situation that led to the lawsuit. A consent decree is a settlement that is contained in a court order. focused around certain solid organ transplant solid organ transplant Immunology A transplanted solid organ–eg, heart, liver, kidney, as contrasted to 'liquid' transplanted tissues–eg, BM, pancreatic islets. See Transplant, Transplantation. applications of Campath (alemtuzumab for injection). ILEX shareholders voted to approve the merger with Genzyme in early July. The closing of the transaction remains subject to receipt of clearance of the FTC under the Hart-Scott-Rodino Antitrust Improvements Act The Hart-Scott-Rodino Antitrust Improvements Act of 1976 (Public Law 94-435, known commonly as the HSR Act) is a set of amendments to the antitrust laws of the United States, principally the Clayton Antitrust Act. The HSR Act was signed into law by President Gerald R. of 1976 and other closing conditions. Genzyme also announced it has successfully completed its principal Phase 4 study of Fabrazyme and performed a preliminary analysis of the results. Completing the study was one of the requirements specified by the 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. when it approved the product for the treatment of Fabry disease in April 2003. Fabry disease is a very rare and potentially fatal hereditary disorder that can lead to renal failure, heart disease and stroke. The company says it plans to submit a summary study to the FDA this month. The company will also submit the study to regulatory authorities in the European Union and certain other regions to fulfill post-approval commitment next year. Contact: Genzyme Web site - www.genzyme.com |
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