Date: 2015-03-07
Type of information: Termination of the agreement
Compound: Latuda® (lurasidone)
Company: Sumitomo Dainippon Pharma (Japan) Takeda Pharmaceutical (Japan)
Therapeutic area: CNS diseases - Mental diseases
Type agreement: termination of an agreement
Action mechanism: serotonin receptor antagonist. Lurasidone is an atypical antipsychotic, developed originally by DSP with an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects. In addition, lurasidone is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine or muscarinic receptors. Takeda entered into a license agreement with DSP stipulating the joint development and grant of an exclusive commercialization right of the product to Takeda in 26 member states of the European Union (excluding the United Kingdom), and Switzerland, Norway, Turkey and Russia in March 2011.
Disease: schizophrenia, bipolar disorder
Details: * On March 30, 2011, Dainippon Sumitomo Pharma and Takeda Pharmaceutical announced that they have entered into a license agreement for the joint development and exclusive commercialization of the oral formulation of lurasidone hydrochloride, an atypical antipsychotic agent developed originally by DSP, for the treatment of schizophrenia and bipolar disorder in 26 member states of the European Union except the United Kingdom, Switzerland, Norway, Turkey and Russia (“Territory”). Takeda will have exclusive commercialization right in the Territory. The UK is excluded from this transaction and the right will be reserved for DSP. Lurasidone was approved for the treatment of schizophrenia in adult patients in the United States by the FDA in October 2010. The two companies will aim for the earliest possible Marketing Authorization Application filing of lurasidone in the Territory with joint development based on the global studies carried out by DSP. In regard to a future Marketing Authorization Application filing, consultation is on-going to determine whether additional clinical studies are necessary before the MAA for either of the two targeted indications can be submitted to the European Medicines Agency.
Financial terms: Under terms of the agreement, Takeda will make an upfront payment of 10 Billion Japanese Yen and milestone payments up to approximately $180 million in the event of a Marketing Authorization Application filing and MAA approval for targeted indications: schizophrenia and bipolar disorder. Upon commercialization, Takeda will pay royalty to DSP based on net sales in the Territory, and DSP will supply the product to Takeda. In addition, after the execution of this agreement, future development costs necessary for Marketing Authorization Application filing and its approval in the Territory will be shared between DSP and Takeda at a certain fixed ratio. Further details of the economic conditions are not disclosed. With respect to DSP’s financials, the upfront will be added to net sales and operating income this quarter (Jan 1 - Mar 31, 2011). Revisions to the financial forecast for this fiscal year in regards to other license agreements and recent achievement trends are announced today. Takeda will record the upfront payment in this fiscal year ending March 31, 2011, and will not revise its financial forecast for this fiscal year.
Latest news: * On May 7, 2015, Sumitomo Dainippon Pharma and Takeda Pharmaceutical jointly announced that their license agreement entered into in March 2011 for the joint development and exclusive commercialization of pharmaceutical products containing lurasidone hydrochloride (Latuda®) 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. 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®.
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.
