Positive pivotal results on escitalopram in Japan - Lundbeck's partner Mochida plans to file escitalopram for regulatory approval in first quarter 2011 at the latest
H. Lundbeck A/S (Lundbeck) today announced that the results from the pivotal study with escitalopram in Japan have been received. The results are positive and according to expectations.
In April 2008 Mochida Pharmaceutical Co., Ltd. (Mochida) initiated the clinical phase III placebo-controlled study in major depression (MDD). Approximately 480 patients with MDD were randomised to receive escitalopram (10 or 20mg), paroxetine or placebo. 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 Pharma Corporation. The financial terms of the agreement have not been disclosed, but Lundbeck is to receive regulatory milestone payments and royalties on sales. Following the results of the pivotal trial in Japan, Mochida will proceed towards a regulatory filing of escitalopram in Japan in the first quarter of 2011 at the latest. If approved, Lundbeck expects that escitalopram in Japan could be an important contributor to Lundbeck's financial performance in the coming years. Japan anti-depressant market 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. In 2009, the Japanese antidepressant market (N6A) had a value of USD 1.1 billion according to IMS, and increasing with double digit growth rates in the past years. The three most dominant 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%. 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, IR & Communication 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#1416194]