H. Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. announce European Commission approval for Rxulti® (brexpiprazole) for the treatment of schizophrenia in adults

Rxulti® (brexpiprazole) has been approved for the treatment of schizophrenia in adults.

VALBY, 01-Aug-2018 — /EuropaWire/ — H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce that the European Commission has approved Rxulti^® (brexpiprazole) for the treatment of schizophrenia in adults. The approval follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) on May 31, 2018.

Lundbeck and Otsuka will now work with local pricing and reimbursement bodies in countries throughout Europe to help ensure that eligible patients are able to access Rxulti^®. The medicine is expected to be made available in the first EU markets during first half of 2019.

Brexpiprazole is a once-daily second generation (atypical) oral antipsychotic; it provides a combination of partial agonist activity at serotonin 5-HT_1A and dopamine D₂ receptors, and antagonist activity at serotonin 5-HT_2A receptors.¹ Brexpiprazole exhibits high affinity for these receptors as well as for noradrenaline alpha_1B/2C receptors.¹ Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck.

Contacts

Mads Kronborg
Senior Director, Corporate Communication, H. Lundbeck A/S
Phone: +45 36 43 40 00
E-mail: mavk@lundbeck.com

(In Europe)                                                     (Outside Europe)
Alison Ross                                                     Jeffrey Gilbert
Head of Communications – Europe          Leader, Pharmaceutical Public Relations
Otsuka Pharmaceutical Europe Ltd.          Otsuka Pharmaceutical Co., Ltd.
+44 (0)203 7475000                                     +81 3 6361 7379
ARoss@Otsuka-Europe.com                        Gilbert.jeffrey@otsuka.jp

About Lundbeck
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 depression, schizophrenia, Parkinson’s disease and Alzheimer’s disease.

An estimated 700 million people worldwide are living with psychiatric and neurological disorders and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with psychiatric and neurological disorders – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.

Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. Our research centre is based in Denmark and our production facilities are located 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 Otsuka
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has R&D programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka established a presence in Europe in 1974 and today Otsuka Pharmaceutical Europe Ltd. employs approximately 600 people who channel their passion and energy into converting the latest science into much-needed medicines.

Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 46,000 people worldwide and had consolidated sales of approximately EUR 9.8 billion in 2017.

All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at https://www.otsuka.co.jp/en. Learn more about Otsuka in Europe at www.otsuka-europe.com or visit our Twitter page www.twitter.com/otsukaeurope.

¹ Maeda K, et al. J Pharmacol Exp Ther. 2014b; 350(3): 589–604.

Attachment

• Lundbeck and Otsukas Rxulti (brexpiprazole) approved by European Commission

SOURCE: H. Lundbeck A/S