Sumitomo Dainippon Pharma Co., Ltd. , Takeda Terminate Latuda Agreement

Sumitomo Dainippon Pharma and Takeda Announce Decision to Terminate their Agreement for the Joint Development and Commercialization of Latuda

Sumitomo Dainippon Pharma Co., Ltd. and Takeda Pharmaceutical Company Limited on May 7 jointly announced that their license agreement entered into in March 2011 ("Agreement") for the joint development and exclusive commercialization of pharmaceutical products containing lurasidone hydrochloride (Latuda), an atypical antipsychotic agent, in Europe, will be terminated.

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

Takeda’s right to develop and commercialize 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 finalized,” said Christophe Weber, Chief Executive Officer (CEO), 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 commercialization 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.

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