Valby, Denmark, and Osaka, Japan, 8 June 2018 - H. Lundbeck A/S (Lundbeck) and Takeda Pharmaceutical Company Limited (Takeda) today announced positive results from the pivotal study with vortioxetine in adults with Major Depressive Disorder conducted in Japan. Both companies intend to move forward with regulatory filing of vortioxetine later this year to the Ministry of Health, Labor and Welfare in Japan.
In April 2015, Takeda initiated the clinical phase III placebo-controlled study (NCT02389816) in MDD. Approximately 490 patients with recurrent MDD were randomized to receive vortioxetine (10 and 20 mg) or placebo. The primary endpoint was the change from baseline (i.e. the start of double-blind treatment) in the Montgomery—Åsberg Depression Rating Scale (MADRS) total score after 8 weeks of treatment.
About Major Depressive Disorder (MDD)
MDD is a complex mental health illness that affects approximately 300 million people globally. Also known as clinical depression, MDD is the leading cause of disability worldwide and a major contributor to the overall global burden of disease. MDD may trigger emotional, cognitive and physical symptoms, which includes depressed mood, loss of interest or pleasure, significant weight loss or gain or change in appetite, insomnia or hypersomnia, psychomotor agitation or retardation, fatigue or loss of energy, feelings of worthlessness or excessive guilt, diminished ability to think or concentrate, or indecisiveness, and recurrent suicidal ideation.
The mechanism of the antidepressant effect of vortioxetine is not fully understood. It is an inhibitor of serotonin (5-HT) reuptake and that is thought to be a mechanism of its action. It is also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors. The contribution of each of these activities to vortioxetine's antidepressant effect has not been established. It is considered to be the first and only compound with this combination of pharmacodynamic activity. The clinical relevance of this is unknown.
Vortioxetine was discovered by Lundbeck researchers in Copenhagen, Denmark. The clinical trial program in Japan was conducted by Takeda.
The World Health Organization has issued an Anatomical Therapeutic Chemical (ATC) code for vortioxetine that places it in the category of "Other" antidepressants
The U.S. Food and Drug Administration (FDA) approved vortioxetine (Trintellix®) on 30 September 2013 for the treatment of MDD in adults. Vortioxetine is furthermore approved in 77 markets (including Europe, Canada, Chile, China, Mexico, Argentina, South Korea, Turkey, Australia, Hong Kong, Singapore and South Africa). It is available in more than 60 countries to date. Outside North America, vortioxetine is recognized as Brintellix®.
Palle Holm Olesen Mads Kronborg
Vice President, Investor Relations Senior Director, Corp. Communication
+45 30 83 24 26 +45 36 43 40 00
Takeda Pharmaceutical Company Limited contacts
Japanese media: Media outside Japan:
Tsuyoshi Tada Rachel Wiese
+81 (0) 3-3278-2417 +1-917-796-8703
About H. Lundbeck A/S
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are Alzheimer's disease, depression, Parkinson's disease and schizophrenia.
Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, manufacturing, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have production facilities in Denmark, France and Italy. Lundbeck generated revenue of DKK 17.2 billion in 2017 (EUR 2.3 billion; USD 2.6 billion).
For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as Takeda's presence in emerging markets, are currently fueling the growth of Takeda. Approximately 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda's partners in health care in more than 70 countries. For more information, visit https://www.takeda.com/newsroom/.
Safe Harbor/Forward-Looking Statements
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 World Health Organization (WHO). Depression. http://www.who.int/news-room/fact-sheets/detail/depression. Accessed on 4 June 2018.