Escitalopram filed in Japan
H. Lundbeck A/S (Lundbeck) today announced that our partner Mochida Pharmaceutical Co., Ltd. (Mochida) has filed a new drug application (NDA) for escitalopram for the treatment of depression with the Japanese Ministry of Health, Labour and Welfare (MHLW). If approved, Lundbeck expects that escitalopram in Japan would be a meaningful contribution to Lundbeck's financial performance already in the period 2012-2014. The commercialization of escitalopram will be supported by two highly CNS-experienced Japanese companies which will co-market the product; Mochida and Mitsubishi Tanabe Pharma Corporation (Mitsubishi Tanabe). Yoshitomiyakuhin Corp., a subsidiary of Mitsubishi Tanabe, will participate in the promotion. This means that the launch will be supported by more than 1,500 sales reps, which is fully competitive in the Japanese market. "We are very excited about the early filing of escitalopram in Japan and we are now one step closer in making escitalopram available also for the Japanese patients," says Ulf Wiinberg, President & Chief Executive Officer at Lundbeck. "The Japanese antidepressant market represents a substantial commercial opportunity, and would contribute meaningfully to Lundbeck's financial performance already in the period 2012-2014." The Japanese anti-depressant market In 2009, the Japanese antidepressant market (N6A) had a value of USD 1.1 billion according to IMS, and experiencing double digit growth rates in the past years. The three most sold antidepressants in Japan were by the end of 2009 paroxetine with a value market share of approximately 42%, sertraline with a share of approximately 20% and fluvoxamine with a share of approximately 16%. The number of patients with depression in Japan is increasing every year, and is currently estimated to exceed one million. Escitalopram has been very well-received by patients and doctors worldwide for the treatment of depression, and is expected to offer a new treatment option for patients with depression in Japan. Mochida and Lundbeck alliance In May 2002, Lundbeck entered a license agreement for the development and commercialisation of escitalopram in Japan with Mochida. In January 2010, Mochida announced that the company had signed an agreement to co-market escitalopram in Japan with Mitsubishi Tanabe. The financial terms of the agreement have not been disclosed, but Lundbeck is to receive regulatory milestone payments and royalties on sales. In Japan, Mochida started the development of escitalopram in 2002 and conducted clinical trials in patients with depression. The results of these studies confirmed its efficacy and tolerability, which has led to the filing. Mochida and Lundbeck will continue to strive to obtain the marketing authorization for escitalopram, and thereby contribute to the treatment of depression in Japan. Financial guidance The content of this release will have no influence on the Lundbeck Group's financial guidance for 2010 which was provided on 4 March 2010 in connection with the release of the financial results for 2009. Lundbeck contacts Investors: Media: Jacob Tolstrup Mads Kronborg Vice President, Corporate Relations Media Relations Manager +45 36 43 30 79 +45 36 43 28 51 Palle Holm Olesen Stine Hove Marsling Chief Specialist, Investor Relations External Communication Specialist +45 36 43 24 26 +45 36 43 28 33 Magnus Thorstholm Jensen Investor Relations Officer +45 36 43 38 16 About Lundbeck H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improve the quality of life for people suffering from central nervous system (CNS) disorders. For this purpose Lundbeck is engaged in the research and development, production, marketing and sale of pharmaceuticals across the world, targeted at disorders like depression and anxiety, schizophrenia, insomnia, Huntington's, epilepsies, Alzheimer's and Parkinson's diseases. Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark, and employs today approximately 5,900 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with CNS disorders. In 2009, the company's revenue was DKK 13.7 billion (approximately EUR 1.8 billion or USD 2.6 billion). For more information, please visit www.lundbeck.com. [HUG#1444377]