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           18 February, 2020

Category:  Press » Health & Fitness


Eslax(R) (Rocuronium Bromide) Approved in Japan

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2007-08-01 09:55:06     
N.V. Organon

Organon, the human healthcare business unit of Akzo Nobel (Euronext Amsterdam: AKZ), today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved rocuronium bromide, its neuromuscular blocking agent (NMBA) for use during general anesthesia, under the brand name Eslax(R). This drug has a fast onset of action and is one of the most widely used muscle relaxants in the United States, Canada and many European countries (marketed under the brand names Zemuron(R)/Esmeron(R)).

Rocuronium bromide was first introduced in the USA in 1994, and quickly became one of the most commonly used muscle relaxants in many countries. It has a proven safety profile and has been used in over 140 million patients, including an estimated 20 million patients in 2006.

Nippon Organon, Organon's Japanese affiliate, is preparing to introduce the drug in the course of this year. This will be the next innovation by Organon in a long line for the Japanese anesthesia market following on the introduction of Mioblock(R) (pancuronium bromide), Musculax(R) (vecuronium bromide) and TOF-Watch(R).

Welcoming the introduction of this important new agent, Professor Takeda, department of Anesthesiology, Keio University, Japan commented: "The introduction will undoubtedly contribute to greater patient safety during surgery in Japan. This agent's rapid onset of action allows almost all patients to be intubated within approximately one minute of its administration. Additionally, it will come in a ready-to-use solution and no active metabolites with the drug have been shown in clinical trials to date which further contributes to safety and ease of continuous infusion. Japanese anesthesiologists will certainly welcome this important new drug to their armamentarium as it will provide rapid and reliable neuromuscular relaxation."

"We work to be a well respected partner for the anesthesiology professionals in Japan and I am pleased we will bring them a new drug that has already earned a strong position around the rest of the world," added Willem de Laat, executive vice president Medical Affairs, Organon, "In our commitment to the anesthesia field we will continue to work in close partnership with the Japanese anesthesiology professionals to develop innovative and safe solutions that assist them in caring for their patients."

Background information

NMBAs (muscle relaxants), including rocuronium bromide (Eslax(R)/Esmeron( R)/ Zemuron(R)), are administered during surgery to facilitate safe and rapid endotracheal intubation (placing a tube in the windpipe to facilitate artificial ventilation) and provide total skeletal muscle relaxation. Although not all surgeries require the use of muscle relaxants, they are often used when the surgeon requires the patient's muscles to be relaxed during the procedure. When the procedure is completed, the NMBA needs to either wear off spontaneously (which can take some time) or be actively reversed so that the patients can breathe spontaneously as they are awakened and the endotracheal tube is removed.

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(X)

This press release may contain statements which address such key issues as growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals of Organon. 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 http://www.akzonobel.com.

(X)Pursuant to the U.S. Private Securities Litigation Reform Act 1995.

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