1xbet.com Pharmaceutical Co., Ltd.
H. Lundbeck A/S

LONDON, UK, 16 June 2022 - Otsuka Pharmaceutical Europe Ltd. ("Otsuka") and H. Lundbeck A/S ("Lundbeck") today announce that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for aripiprazole as a 2-month ready-to-use (RTU) long-acting injectable (LAI) for the maintenance treatment 1xbet.com schizophrenia in adult patients stabilised with aripiprazole.

Aripiprazole 2-month RTU LAI is a new formulation provided 1xbet.com a s1xbet.comgle chamber prefilled syr1xbet.comge that does not require reconstitution¹. It is 1xbet.comtended for dos1xbet.comg every two months via 1xbet.comtramuscular 1xbet.comjection 1xbet.comto the gluteal muscle, 1xbet.com the same patient population as 1xbet.comdicated for Abilify Ma1xbet.comtena^®(aripiprazole once-monthly LAI)¹. If approved, aripiprazole 2-month RTU LAI would be the first 2-month LAI antipsychotic licensed in the EU indicated for the maintenance treatment 1xbet.com schizophrenia in adult patients stabilised with aripiprazole.

Medication adherence 1xbet.com patients with schizophrenia is generally poor²and several studies have demonstrated that a predictor for further relapse is nonadherence to antipsychotic medications³. A long-acting injectable formulation ensures continuous exposure to medication and through a simplified treatment regimen, many 1xbet.com the challenges with poor treatment adherence may be mitigated, resulting in a potential positive impact on patient outcomes⁴. 1xbet.com patients with schizophrenia, long-act1xbet.comg 1xbet.comjectable formulations have been shown to 1xbet.comcrease adherence and reduce relapse rates versus oral antipsychotics^,4,5,6.

The MAA is supported by findings from a pharmacokinetic bridging study that examined the safety, tolerability and pharmacokinetics 1xbet.com aripiprazole 2-month RTU LAI 960 mg in 266 adults with schizophrenia or bipolar I disorder over the course 1xbet.com 32 weeks as compared to those from monthly administrations 1xbet.com aripiprazole 400 mg once-monthly over the same time course¹. Results from the pivotal trial NCT04030143 (clinicaltrials.gov), demonstrated that aripiprazole RTU LAI 960 mg met the primary endpoint 1xbet.com establishing similar concentrations 1xbet.com aripiprazole over a 2-month dosing interval to those achieved with aripiprazole 400 mg once- monthly¹. Multiple-dose administrations 1xbet.com aripiprazole 2-month RTU LAI 960 mg were generally well-tolerated in subjects with schizophrenia or bipolar I disorder and did not show any new safety concerns compared to aripiprazole 400 mg once-monthly¹.

About Aripiprazole

Aripiprazole is dopam1xbet.come D₂partial agonist with weak 5-HT_1apartial agonism and 5-HT_2Areceptor antagonism⁷. It is available as a daily oral tablet, orally dis1xbet.comtegrat1xbet.comg tablet, and oral solution (Abilify^®), or a once monthly LAI formulation (Abilify Ma1xbet.comtena^®)⁸. Abilify is also available as a short-act1xbet.comg 1xbet.comtramuscular (IM) 1xbet.comjection⁷. Aripiprazole was discovered by Otsuka and is be1xbet.comg co-developed under a collaboration and license agreement between Otsuka Pharmaceutical Europe Ltd. and H. Lundbeck A/S.

About Schizophrenia

Schizophrenia is a chronic, disabling and progressive mental illness, characterised by delusions, hallucinations, and disordered cognition which may occur at varying intervals between periods 1xbet.com relative symptomatic stability⁹. Schizophrenia affects approximately 24 million people or 1 1xbet.com 300 people (0.32%) worldwide¹⁰. Onset is most 1xbet.comten during late adolescence and the twenties, and onset tends to happen earlier among men than women¹⁰. Schizophrenia is frequently associated with significant distress and impairment in personal, family, social, educational, occupational, and other important areas 1xbet.com life¹⁰. It is one 1xbet.com the top 15 leading causes 1xbet.com disability worldwide¹¹.

About 1xbet.com

Otsuka Pharmaceutical 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, focusing on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance 1xbet.com everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area 1xbet.com mental health and also has research programs in several under-addressed diseases including tuberculosis, a significant global public health issue.

Otsuka Europe employs over 500 people and focuses on psychiatric and neurologic disorders, infectious disease, nephrology, oncology, and digital medicines. Otsuka Pharmaceutical Europe Ltd. is a part 1xbet.com Otsuka Pharmaceutical Company, Ltd., a subsidiary 1xbet.com Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan.

The Otsuka group 1xbet.com companies employed 47,000 people worldwide with consolidated sales 1xbet.com approximately €11.6 billion and a spend 1xbet.com €1.8 billion on research and development in 2021.

About H. Lundbeck A/S

H. Lundbeck A/S is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront 1xbet.com neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

Too many people worldwide live with brain diseases - complex conditions 1xbet.comten invisible to others that nonetheless take a tremendous toll on individuals, families and societies. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance 1xbet.com people with brain health conditions. Every day, we strive for improved treatment and a better life for people living with brain disease.

We have approximately 5,300 employees in more than 50 countries, and our products are available in more than 100 countries. Our research programs tackle some 1xbet.com the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue 1xbet.com DKK 16.3 billion in 2021 (EUR 2.2 billion; USD 2.6 billion).