As a consequence of increasing pressure to improve cost efficiency, we conducted a thorough review of our CNS portfolio in 2014, which resulted in a number of projects being either terminated or suspended and a related reduction in personnel. We have also rationalised our research activities, as far as the target areas are concerned, as a result of which we have narrowed our focus to obesity, cognitive disorders and autism.
Bipolar I Disorder
Bipolar disorder affects approximately 3.6 million people in the United States. Bipolar I disorder is also known as manic- depressive illness. People with bipolar I disorder experience "mood episodes" ranging from manic episodes (i.e., overexcited, extreme irritability, racing thoughts, difficulties with sleep), depressive episodes (i.e., extreme sadness, fatigue, hopelessness) or mixed episodes (a combination of both mania and depression).
Schizophrenia is a chronic and disabling disorder that affects more than 2.6 million American adults. It imposes a significant burden on patients, their families and society. Symptoms fall into three broad categories: positive symptoms (hallucinations, delusions, thought disorders and movement disorders), negative symptoms (such as loss of motivation and social withdrawal) and cognitive symptoms (problems with executive functioning, focusing and working memory).
Cariprazine is an oral, once daily atypical antipsychotic which was approved by the FDA in September 2017 for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults. The safety and efficacy of cariprazine was studied in a clinical trial program of more than 2,700 patients with these conditions. The product was introduced in the US market under the trademark of VRAYLAR™ on 16 March 2016.
Cariprazine is also being investigated for the treatment of bipolar depression and as adjunctive treatment for major depressive disorder in adults.
Additionally Allergan has been in active discussions with FDA regarding the submission of an efficacy supplement to provide for the treatment of predominantly negative symptoms of schizophrenia (PNS). It followed an announcement made by Richter in January 2015, about a positive Phase III study that evaluated cariprazine for the treatment of PNS, which is a serious unmet need for which there are no approved treatment options available.
The EMA started the evaluation of Richter's marketing authorisation application for cariprazine for the treatment of schizophrenia in March 2016.
Our Japanese partner, MitsubishiTanabe Pharma, also conducts clinical development to fulfil the regulatory requirements for product introduction on the Japanese market.
The success of cariprazine could be considered as an important historical event not just for the Company but equally for the whole Hungarian pharmaceutical industry. This is the first pharmaceutical compound which was discovered by a Hungarian company and the preclinical research and development were also carried out in the same Hungarian pharmaceutical company.