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Organon's Marketing Authorization Application for Sugammadex Accepted for Review by EMEA
Oss, The Netherlands (ots/PRNewswire) - Organon, the human healthcare business unit of Akzo Nobel, announced today that the Marketing Authorization Application (MAA) for sugammadex has been accepted for review by the European Medicines Agency (EMEA). This novel selective relaxant binding agent (SRBA) is specifically designed to reverse the effects of the muscle relaxant rocuronium bromide (Esmeron(R)/Zemuron(R)) used as part of general anesthesia during surgical procedures.
Sugammadex works by encapsulating the muscle relaxant molecule and forming a tight complex. The encapsulation of the muscle relaxant by sugammadex removes the drug from its site of action and renders it inactive.
'Reversal of neuromuscular blockade is used to reduce the risk of post operative residual curarization (PORC) or re-occurrence of muscle relaxation; which may cause a number of serious complications such as muscle weakness and breathing difficulties,' commented Willem de Laat, executive vice president Medical Affairs Organon.
The MAA is based on safety and efficacy data from over 1700 patients including data from ten global Phase III trials. The results of four of these Phase III trials were presented on June 11th at the 14th annual Euroanaesthesia 2007 congress in Munich, Germany.
In the clinical trials conducted to date, sugammadex has generally demonstrated the ability to reverse shallow and profound depths of rocuronium-induced neuromuscular blockade within 3 minutes, thereby enabling control of the onset and offset of skeletal muscle relaxation through the use of both drugs. Sugammadex has also demonstrated to reverse the effects of vecuronium-induced (Norcuron(R)) neuromuscular blockade.
Sugammadex's global Phase III development program - consisting of 5 US trials and 5 European trials - completed recruitment in late 2006. The anticipated submissions for the US and Japan are proceeding in line with the previously disclosed timelines.
Organon creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of innovation and business partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It has extensive expertise in neuroscience and a rich and focused R&D program. Research areas also include immunology and specific areas of oncology. Organon products are distributed in over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is the human healthcare business unit of Akzo Nobel.
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This press release may contain statements which address such key issues as Akzo Nobel's growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals. Such statements should be carefully considered, and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to, price fluctuations, currency fluctuations, progress of drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, pensions, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies. For a more comprehensive discussion of the risk factors affecting our business please see our Annual Report on Form 20-F filed with the United States Securities and Exchange Commission, a copy of which can be found on the company's corporate website www.akzonobel.com. The 2006 Annual Report on Form 20-F will be available in the second quarter of 2007.
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ots Originaltext: N.V Organon
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