H. Lundbeck A/S (Lundbeck) today announced that the first patients have been recruited and dosed in the new phase III programme using Lu AA21004 in major depression (MDD). The first patients have been recruited in Finland. As previously communicated filing of Lu AA21004 is anticipated in 2012. The extended phase III programme for Lu AA21004 is based on clinical data obtained until now. Available data show encouraging results for the potential efficacy and the tolerability profile of Lu AA21004: * A European based 560-patient placebo-controlled MDD study shows statistical significance on the primary efficacy endpoint across all tested doses. * Additionally a 639-patient relapse prevention study shows statistical significance in maintenance of efficacy in long-term treatment of MDD. * Supportive study shows separation from placebo with 5 and 10 mg doses. * Finally, the proof of concept study (clinical phase II) shows statistical significance on all tested doses The phase III programme aims to recruit patients from Europe, as well as the US and Canada in cooperation with our partner Takeda Pharmaceutical Company Limited (Takeda). About Lu AA21004 Lu AA21004 is an investigational multi-modal antidepressant that combines two pharmacological modes of action; reuptake inhibition and receptor activity. Lu AA21004 is a 5-HT(3), 5-HT(7) and 5-HT(1B) receptor antagonist, 5‑HT(1A) receptor agonist and 5-HT transporter inhibitor. A number of investigations in vivo have demonstrated that Lu AA21004 increases extracellular monoamine (5-HT, noradrenaline and dopamine) and acetylcholine and histamine levels in specific areas of the brain. All of these activities are considered to be of clinical relevance and potentially involved in the mechanism of action of Lu AA21004. Lu AA21004 has demonstrated a low drug-drug interaction potential. It is extensively metabolized in the liver and the absorption of Lu AA21004 is independent of food intake. About depression Depression is a very common, debilitating illness affecting around 121 million people worldwide according to WHO. Depression was the leading cause of disability as measured by YLD (Years of Life lived with Disability) and the 4th leading contributor to the global burden of disease as measured by DALYs (Disability Adjusted Life Year) in 2000. By the year 2020, depression is projected to reach 2(nd) place of the ranking of DALYs calculated for all ages, both sexes. The symptoms of depression can be chronic or recurrent, and impact patients both mentally and physically, yet it is still under-recognized and undertreated with less than 25 percent of those affected having access to adequate treatment for their condition[1]. Symptoms can include feelings of sadness, anxiety, loss of interest in activities, decreased energy, impaired sleep, impaired concentration, hopelessness, guilt, persistent physical symptoms such as pain and digestive disorders, and in more severe cases, suicidal thoughts and suicide attempts. Takeda and Lundbeck alliance In September 2007, Lundbeck and Takeda formed a strategic alliance for the exclusive co-development and co-commercialization in the United States and Japan of several compounds in Lundbeck's pipeline for the treatment of mood and anxiety disorders. The partnership initially focuses on co-development and co-commercialization of the two most advanced compounds in Lundbeck's pipeline for mood and anxiety disorders, Lu AA21004 and Lu AA24530. Once approved, the companies will co-promote the products in the United States and 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, 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. -------------------------------------------------------------------------------- [1] http://www.who.int/mental_health/management/depression/definition/en/ [HUG#1419090]
First patients recruited in the extended phase III programme using Lu AA21004 in MDD
| Source: H. Lundbeck A/S