Sumitomo Dainippon Pharma Company Limited and Takeda Pharmaceutical Company Limited, announced termination of their license agreement for the joint development and exclusive commercialisation of pharmaceutical products containing lurasidone hydrochloride (Latuda), an atypical antipsychotic agent, in Europe.

The companies signed the license pact in March 2011.

The companies are starting discussions in an effort to finalise and execute a mutual agreement establishing a transition plan for the orderly transfer of all development and commercialisation rights and activities with respect to Latuda to Sumitomo Dainippon Pharma.

Takeda’s right to develop and commercialise Latuda within 26 member states of the European Union (excluding the United Kingdom), Switzerland, Norway, Turkey and Russia, will transfer back to Sumitomo Dainippon Pharma upon the effective date of the termination.

The termination of the agreement is based on market and business considerations of Takeda and is not the result of new safety or efficacy information on Latuda. Sumitomo Dainippon Pharma and Takeda continue to believe that Latuda is an appropriate treatment option for adult patients with schizophrenia with minimal impact on important measures of metabolic health. Latuda has been available in the United States since 2011, in Canada since 2012, and subsequently in six countries in Europe. During this time it is estimated that more than one million patients have been treated with Latuda.

“Patients are Takeda’s primary focus and we are committed to working closely with Sumitomo Dainippon Pharma during this transition period to ensure that transparent communication with patients and health care professionals is maintained as plans are finalised,” said Christophe Weber, chief executive officer, Takeda Pharmaceutical Company Limited.

“In parallel Takeda takes its commercial partnerships very seriously and we will work with absolute integrity to see current commitments through as the companies work together to transition development and commercialisation rights and activities to Sumitomo Dainippon Pharma.”

“We remain committed to ensuring continued access to Latuda for patients in Europe, and to further contributing to the treatment of schizophrenia and other psychiatric disorders,” said Masayo Tada, President and Chief Executive Officer (CEO), Sumitomo Dainippon Pharma. “We will consider all options, including collaboration with a new partner, for the continued development and commercialization of Latuda in Europe.”

The termination of the agreement is expected to have minor impact on the consolidated business performance of Sumitomo Dainippon Pharma and Takeda in the fiscal year ending March 2016.

Latuda is an atypical antipsychotic developed originally by Sumitomo Dainippon Pharma, characterised by a unique chemical structure and an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects. In addition, Latuda is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine or muscarinic receptors. The most frequent adverse reactions seen in short-term clinical studies (incidence = 5 per cent and at least twice as frequent as with placebo) were somnolence, akathisia, nausea, parkinsonism and dystonia.

Latuda was approved for the treatment of schizophrenia in adults by the European Commission (EC) in March 2014 and Swiss Medic in August 2013. Latuda is currently available in Switzerland, Denmark, Norway, Finland, the Netherlands and the UK. Outside of Europe, Latuda is available in the USA and Canada for the treatment of schizophrenia and bipolar depression in adults.

Latuda has also been approved in Australia for the treatment of schizophrenia in adults. Latuda has been available in the USA since 2011 and in Canada since 2012, in Switzerland since 2013, in Denmark, Norway and the UK since 2014, and in the Netherlands and Finland since 2015.

Located in Osaka, Japan, Sumitomo Dainippon Pharma defines its corporate mission as “to broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide”.

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals.