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Organon to Submit Antidepressant Mirtazapine for Approval in Japan Significantly Earlier Than Expected

OSS, The Netherlands, Jan. 11, 2007-Organon-the human healthcare business unit of Akzo Nobel - announced today that it anticipated filing a new drug application for its novel antidepressant mirtazapine (known as Remeron® in most countries) to Japanese health authorities (PMDA) towards the middle of 2007, three years earlier than expected.
“This is very exciting news for us, “said Emile van Dongen, executive vice president global sales. “The Japanese market is an important market and we are confident that mirtazapine’s fast onset of action and tolerability will make it a first line option for the treatment of depression in Japan.”

Mirtazapine  - a Noradrenergic and Selective Serotonergic Antidepressant (NaSSA) - has been available in other countries since 1994. Mirtazapine has a unique mechanism of action and has been proven safe and effective in the treatment of major depression in many countries. Nippon Organon has been developing mirtazapine in Japan for depression in partnership with Meiji Seika Kaisha since 2004.

The Phase IIb trials in the Japanese population demonstrated superior efficacy of mirtazapine over placebo. Earlier this year Nippon Organon and Meiji Seika Kaisha discussed how to further develop mirtazapine with the Japanese health authorities. As a result of this discussion they are now confident that they can submit an NDA in Japan some time towards the middle of 2007.

Hans van Eerd, Organon Nippon’s general manager added: “The efforts and hard work of all the teams involved, Nippon Organon team, global mirtazapine team and our developmental partner Meiji Seika Kaisha have driven this success.”
About Organon
Organon – with shared head offices in Roseland, NJ, USA and Oss, The Netherlands – creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to remain or become one of the leading biopharmaceutical companies in each of its core therapeutic fields: fertility, gynecology, anesthesia and neuroscience. Research areas also include immunology and oncology. Organon products are sold in over 100 countries, of which more than 50 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel.
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Posted: January 2007