In what has been a busy week for the firm, Akzo Nobel’s pharmaceutical arm Organon has announced plans to file a new drug application for its antidepressant Remeron in Japan, three years earlier than expected.
The company said that the filing of Remeron (mirtazapine) will be made to the Japanese health authorities (the Pharmaceutical and Medical Devices Agency) towards the middle of 2007. Nippon Organon has been developing mirtazapine in Japan for in partnership with Meiji Seika Kaisha since 2004 and Phase IIb trials in the Japanese population have demonstrated superior efficacy of the drug over placebo.
Emile van Dongen, executive vice president of global sales at Organon said “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.”
Remeron has been on the market elsewhere since 1994 and has been Organon’s best-selling drug ever. It had peak sales of about 700 million euros, but has declined since it lost patent protection in the USA in 2001. Third quarter 2006 sales of the drug were down 10% on the corresponding period in 2005 to 61 million euros.
Analysts estimate that revenue from Remeron in Japan could boost Organon’s pretax profits by 25-30 million euros in its peak sales year. The Japanese antidepressants market is valued at around 700 million euros in annual sales, and if the filing is accepted, Remeron will get six years’ patent protection.
News of the filing in Japan comes in the same week as Organon announced a research collaboration with The Netherland's Academic Medical Center to find a novel therapy for the treatment of rheumatoid arthritis and signed a deal with Huya Bioscience International, a firm which focuses on developing Chinese biopharmaceutical products.