H. Lundbeck A/SH. Lundbeck A/S (Lundbeck) and Takeda Pharmaceutical Company Limited (Takeda) jointly have announced headline results from the first three clinical trials in the phase III development programme with Lu AA21004 in major depressive disorder (MDD). Previously reported clinical phase II data showed equal efficacy with the 5 and 10 mg doses.

In the recently completed phase III clinical trials, Lu AA21004 was tested in doses of 2.5, 5 and 10 mg. Results from two studies, which included the lower dosages, 2.5 and 5 mg, did not reach significance across studies when compared with placebo.

A third trial demonstrated mixed results, with the 2.5 mg dose not reaching statistical significance compared to placebo, and the 5 and 10 mg doses showing separation from placebo, although not in all analyses. These results also suggest that a higher dose may be more efficacious.

In all of these trials, Lu AA21004 was well tolerated and confirmed the previously observed favourable safety profile.

As a result, the most appropriate dose of Lu AA21004 needs to be established. It is anticipated that this work will postpone submission of the new drug application (NDA) in the US with approximately 18-24 months. Lundbeck and Takeda will continue to work with the U.S. Food and Drug Administration (FDA) and other regulatory agencies on the clinical development program and submission plans.

Lu AA21004 is also in phase III development for generalised anxiety disorder (GAD).

About depression
Depression is a very common, debilitating illness affecting around 121 million people worldwide. Depression is not at all recognised by society as the serious disorder it actually is. The symptoms of depression can be chronic or recurrent, and impact patients both mentally and physically. Depression has a significant impact on patient quality of life and imposes a considerable burden on society, yet it is still under-recognised and undertreated with less than 25 percent of those affected having access to effective treatment.

Symptoms 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, H. Lundbeck A/S and Takeda Pharmaceutical Company Limited 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.

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, Alzheimer's and Parkinson's diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark, and employs today over 5,500 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with CNS disorders. In 2008, the company's revenue was DKK 11.3 billion (approximately EUR 1.5 billion or USD 2.2 billion). For more information, please visit www.lundbeck.com.

About Takeda
Located in Osaka, Japan, Takeda (TSE:4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, www.takeda.com.