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20.07.2007 – 09:58

N.V. Organon

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
'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.
About sugammadex:
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.
About Organon
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.
Safe Harbor Statement (1)
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 The 2006
Annual Report on Form 20-F will be available in the second quarter of
(1) Pursuant to the U.S. Private Securities Litigation Reform Act


For more information: Monique Mols, Director media relations, Tel:
+31-(0)412-665440, E-mail: