Organon, the pharmaceutical arm of Azko Nobel, has filed a new drug application in Japan for its antidepressant Remeron, along with partner Meiji Seika Kaisha.
The application has been made to the Japanese health authorities (the Pharmaceutical and Medical Devices Agency)some three years earlier than was originally forecast and although Remeron (mirtazapine) has been available elsewhere since 1994, the two firms have been developing the product specifically for the Japanese market since 2004.
Organon and Meiji Seika Kaisha noted that Phase IIb trials in the Japanese population demonstrated efficacy of mirtazapine over placebo and that these results, together with the earlier-obtained data from a Phase III trial comparing Remeron with fluvoxamine in Japanese patients show that the drug may be a first-line option for the treatment of depression in the country.
The Netherlands-headquartered group said that the lifetime incidence of depression in Japan is estimated to be 6.5%, indicating that about seven million people suffer from the condition, a considerable market seeing as Remeron will get six years’ patent protection, if approved. It is Organon’s best-selling drug ever and had peak sales of about 700 million euros, but this figure has declined since the compound lost patent protection in the USA in 2001.Full-year 2006 sales of the drug were down 11% to 253 million euros.
Organon acquires FAAH technology from Kadmus
Organon, which is in the process of being acquired by Schering-Plough for 11 billion euros, recently noted that it has acquired the fatty acid amide hydrolase technology of USA-based Kadmus Pharmaceuticals for an undisclosed sum.
The company said that under the terms of the deal agreement, it has gained control of all FAAH worldwide rights and assets currently controlled by Kadmus, including KDS-4103, “a Phase I-ready compound”. Organon added that FAAHs are being developed as promising new pharmacological agents which selectively augment endogenous cannabinoid activity, and show “considerable promise for treating several types of pain, anxiety, depression, along with potential spin-off indications”.