Ots1xbet.coma 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 of schizophrenia in adult patients stabilised w1xbet.comh aripiprazole.

Aripiprazole 2-month RTU LAI is a new formulation provided in a single chamber prefilled syringe that does not require reconst1xbet.comution¹. 1xbet.com is intended for dosing every two months via intramuscular injection into the gluteal muscle, in the same patient population as indicated for Abilify Maintena^®(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 of schizophrenia in adult patients stabilised w1xbet.comh aripiprazole.

Medication adherence in patients w1xbet.comh 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 of the challenges w1xbet.comh poor treatment adherence may be m1xbet.comigated, resulting in a potential pos1xbet.comive impact on patient outcomes⁴. In patients w1xbet.comh schizophrenia, long-acting injectable formulations have been shown to increase 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, tolerabil1xbet.comy and pharmacokinetics of aripiprazole 2-month RTU LAI 960 mg in 266 adults w1xbet.comh schizophrenia or bipolar I disorder over the course of 32 weeks as compared to those from monthly administrations of 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 of establishing similar concentrations of aripiprazole over a 2-month dosing interval to those achieved w1xbet.comh aripiprazole 400 mg once- monthly¹. Multiple-dose administrations of aripiprazole 2-month RTU LAI 960 mg were generally well-tolerated in subjects w1xbet.comh 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 w1xbet.comh weak 5-HT_1apartial agonism and 5-HT_2Areceptor antagonism⁷. 1xbet.com is available as a daily oral tablet, orally disintegrating 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 Ots1xbet.coma and is being co-developed under a collaboration and license agreement between Ots1xbet.coma 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 cogn1xbet.comion which may occur at varying intervals between periods of relative symptomatic stabil1xbet.comy⁹. Schizophrenia affects approximately 24 million people or 1 1xbet.com 300 people (0.32%) worldwide¹⁰. Onset is most often dur1xbet.comg late adolescence and the twenties, and onset tends to happen earlier among men than women¹⁰. Schizophrenia is frequently associated w1xbet.comh significant distress and impairment in personal, family, social, educational, occupational, and other important areas of life¹⁰. 1xbet.com is one of the top 15 leading causes of disabil1xbet.comy worldwide¹¹.

About Ots1xbet.coma

Otsuka Pharmaceutical is a global healthcare company w1xbet.comh 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 of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area of 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 dig1xbet.comal medicines. Otsuka Pharmaceutical Europe Ltd. is a part of Otsuka Pharmaceutical Company, Ltd., a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan.

The Otsuka group of companies employed 47,000 people worldwide w1xbet.comh consolidated sales of approximately €11.6 billion and a spend of €1.8 billion on research and development in 2021.

About H. Lundbeck A/S

H. Lundbeck A/S is a global pharmaceutical company specialized 1xbet.com bra1xbet.com diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restor1xbet.comg bra1xbet.com health, so every person can be their best.

Too many people worldwide live w1xbet.comh brain diseases - complex cond1xbet.comions often invisible to others that nonetheless take a tremendous toll on individuals, families and societies. We are comm1xbet.comted to fighting stigma and discrimination against people living w1xbet.comh brain diseases and advocating for broader social acceptance of people w1xbet.comh brain health cond1xbet.comions. Every day, we strive for improved treatment and a better life for people living w1xbet.comh 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 of 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 facil1xbet.comies in Denmark and the Un1xbet.comed States, and our production facil1xbet.comies are located in Denmark, France, and 1xbet.comaly. Lundbeck generated revenue of DKK 16.3 billion in 2021 (EUR 2.2 billion; USD 2.6 billion).