Takeda Pharmaceutical Company Limited (Takeda) and H Lundbeck A/S (Lundbeck) announced the initiation of a phase III clinical trial in Japan for Lu AA21004 in patients with Major Depressive Disorder (MDD).

This randomized, double-blind and multi-centre phase III clinical trial is expected to enroll approximately 360 patients with MDD and will evaluate the efficacy and safety of Lu AA21004 (5 and 10 mg) compared to placebo. Primary endpoint is change of MADRS total score from baseline after eight weeks.

Lu AA21004 is a structurally novel compound that is different from currently available antidepressants. Data from clinical trials conducted outside Japan have shown encouraging results for the potential efficacy and the tolerability profile of Lu AA21004. In addition to the Japanese study, the ongoing clinical trial programme includes four ongoing short-term studies and two long-term safety studies.

Lundbeck and Takeda will continuously work in collaboration to develop Lu AA21004 in order to provide the drug as soon as possible as a novel treatment with patients suffering from depression.

MADRS (Montgomery-Asberg Depression Rating Scale): A ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes. It is picked out from Comprehensive Psychopathological Rating Scale (CPRS), developed in Sweden.

Lu AA21004 is an investigational multi-modal antidepressant that is thought to work through a combination of two pharmacological modes of action: reuptake inhibition and receptor activity. It functions as a 5-HT3 and 5-HT7 receptor antagonist, 5-HT1A receptor agonist, 5-HT1B receptor partial agonist and inhibitor of the 5-HT transporter. In preclinical studies it has been demonstrated that Lu AA21004 enhances levels of the neurotransmitters serotonin, noradrenaline, dopamine, acetylcholine and histamine in specific areas of the brain. All of the activities are considered to be of clinical relevance and potentially involved in the mechanism of action of Lu AA21004.

Depression is a very common, debilitating illness affecting around 121 million people worldwide, according to WHO. Depression was the leading cause of disability and the 4th leading contributor to the global burden of disease in 2000.

The symptoms of depression can be chronic or recurrent, and impact patients both mentally and physically. 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.

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.

Takeda 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 strive towards better health for patients worldwide through leading innovation in medicine.

H. Lundbeck A/S is an international pharmaceutical company highly committed to improving the quality of life for people suffering from Central Nervous System (CNS) disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company’s products are targeted at disorders such as depression and anxiety, schizophrenia, insomnia, epilepsy and Huntington’s, Alzheimer’s and Parkinson’s diseases.