SYS-CON MEDIA Authors: Pat Romanski, Elizabeth White, Yeshim Deniz, Glenn Rossman, Cynthia Dunlop

News Feed Item

Dainippon Sumitomo Pharma and Takeda Receive Positive CHMP Opinion for Lurasidone - a New Atypical Antipsychotic Medication for Adults with Schizophrenia

OSAKA, Japan, January 24, 2014 /PRNewswire/ --

Dainippon Sumitomo Pharma Co., Ltd. ("DSP") (Head Office: Osaka, Japan) and Takeda Pharmaceutical Company Limited ("Takeda") (Head Office: Osaka, Japan) today jointly announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), has issued a Positive Opinion for lurasidone for the treatment of schizophrenia in adults. Lurasidone is a once-daily oral treatment that is currently available in Switzerland, the United States and Canada having been approved for use by the respective regulatory authorities.

The Positive CHMP Opinion was based on a comprehensive clinical trial program which included placebo and active comparators. Lurasidone was shown to be effective in treating both positive and negative symptoms in acutely psychotic patients with schizophrenia over 6 weeks.[1],[2],[3],[4],[5]In short and longer term clinical studies, lurasidone has demonstrated effectiveness with low rates of metabolic change.[1],[2],[6]  It is important to minimize the adverse effect of treatments on long-term physical health as patients are likely to remain on therapy for many years.

Lurasidone was generally well-tolerated and had low rates of weight increase, as well as lipid and glucose disturbance, in the treatment of patients with schizophrenia. The most frequent adverse reactions seen in short-term clinical studies (incidence ≥ 5% and at least twice as frequent as with placebo) were somnolence, akathisia, nausea, Parkinsonism and dystonia.[7]

"As a practicing psychiatrist, I am interested in new, effective agents for the treatment of severely ill patients with mental disorders. We need effective, well-tolerated and metabolically neutral treatment alternatives. Lurasidone has an interesting profile, which could benefit many patients with schizophrenia" says Philipp Eich MD, Klinik für Psychiatrie und Psychotherapie, Liestal, Switzerland.

Data for lurasidone was presented at last year's European College of Neuropsychopharmacology (ECNP) Congress showing lurasidone to have a favourable metabolic side effect profile[8],[9],[10],[11] and to be a well-tolerated, efficacious option for patients with schizophrenia switching medication.[11]

About Lurasidone

Lurasidone is an atypical antipsychotic, developed originally by Dainippon Sumitomo Pharma Co., Ltd. ("DSP") with a high affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonistic effects. In addition, lurasidone is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine or muscarinic receptors. Lurasidone was approved for the treatment of schizophrenia by the United States Food and Drug Administration in October 2010, by Health Canada in June 2012, and by the Swiss Agency for Therapeutic Products in August 2013. Lurasidone was launched as LATUDA® for the treatment of schizophrenia in adults in the United States in February 2011 and in Canada in September 2012 through DSP's subsidiary Sunovion Pharmaceuticals Inc., and in Switzerland in September 2013 through Takeda. In Japan a Phase III clinical study is underway for the treatment of schizophrenia by DSP.  An application has been filed with the Australian Therapeutic Goods Administration for the treatment of patients with schizophrenia, as well as the Taiwan Food and Drug Administration (TFDA) and further development in the Chinese and Southeast Asian markets is planned.

About schizophrenia

Schizophrenia is a severe chronic mental condition which can affect both men and women. Patients with schizophrenia have a life span that is decreased by approximately 10-22.5 years compared with the general population.[1][2],[13],[14],[15]

Antipsychotic pharmacotherapy is the cornerstone of treatment for patients with schizophrenia, with agents generally classed as typical or atypical. Atypical agents are broadly considered to have tolerability benefits over typical agents.[16] Switching antipsychotic medication is common in the treatment of patients with schizophrenia either due to residual or emergent symptoms, adverse events or tolerability issues.[17],[18]

Direct and indirect costs associated with caring for patients with schizophrenia are considerable and can include utilization of other health services, pharmacotherapy, community care, supportive therapy, informal care and private expenditures, and patient and caregiver lost productivity.[19],[20] Hospitalization associated with patient relapse can significantly increase costs associated with disease management in schizophrenia.[21]

About Dainippon Sumitomo Pharma Co., Ltd.

Dainippon Sumitomo Pharma Co., Ltd., 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 for people worldwide". By pouring all our efforts into the research and development of new drugs, we aim to provide innovative and effective pharmaceutical solutions to people not only in Japan but also around the world in order to realize our corporate mission. Additional information about DSP is available through its corporate website, http://www.ds-pharma.com.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, http://www.takeda.com.


References

  1. Meltzer H et al. Am J Psychiatry 2011;168:957-67
  2. Loebel A et al. Schizophr Res 2013;145(1-3):101-9
  3. Nakamura M et al. J Clin Psychiatry 2009;70:829-36
  4. Ogasa M et al. Psychopharmacol [Berl] 2013;225(3):519-30
  5. Nasrallah H et al. J Psychiatric Research 2013;47(5):670-7
  6. Citrome L et al. Int Clin Psychopharmacol 2012;27:165-76
  7. Company Core Data Sheet (Table 4).
  8. Murthy et al. Lurasidone for the treatment of schizophrenia: pooled analysis of short-term, placebo-controlled trials (Abstract presented at ECNP, 8 October 2013)
  9. Lieberman J.A. et al. Lurasidone in the treatment of early-stage schizophrenia: a post-hoc analysis of three pooled acute treatment studies (Abstract presented at ECNP, 8 October 2013)
  10. Pikalov A et al. Eur Neuropsychopharmacol 2012;22(Suppl 2):S340
  11. McEvoy J.P.et al. Switching to lurasidone in patients with schizophrenia: tolerability and effectiveness at 6 weeks and 6 months (Abstract presented at ECNP, 8 October 2013)
  12. Healy D et al. Mortality in schizophrenia and related psychoses: data from two cohorts, 1875-1924 and 1994-2010. BMJ Open 2012;2:e001810
  13. Chang C-K et al. Life Expectancy at Birth for People with Serious Mental Illness and Other Major Disorders from a Secondary Mental Health Care Case Register in London. PLoS One 2011;6:e19590
  14. Laursen TM. Life expectancy among persons with schizophrenia or bipolar affective disorder. Schizophr Res 2011;131:101-4
  15. Tiihonen J et al. 11 year-follow up of mortality in patients with schizophrenia: a population-based cohort study (FINN11 study). Lancet 2009;374:620-7
  16. Lewis DA and Lieberman JA. Neuron 2000;28:325-34
  17. Faries DE et al. Clinical and economic ramifications of switching antipsychotics in the treatment of schizophrenia. BMC Psych 2009;9:54
  18. Tsutsumi C et al. The evolution of antipsychotic switch and polypharmacy in natural practice - A longitudinal perspective. Schizophr Res 2011;130:40-6
  19. Salize HJ et al. Cost of schizophrenia in six European countries. Schizophr Res 2009;111(1-3):70-7
  20. Mangalore R and Knapp R. Cost of schizophrenia in England. J Ment Health Policy Econ 2007;10(1):23-41
  21. Zeidler J et al. The costs of schizophrenia and predictors of hospitalisation from the statutory health insurance perspective. Health Econ Rev 2012;2(1):9


More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@CloudExpo Stories
The Internet of Things will greatly expand the opportunities for data collection and new business models driven off of that data. In her session at Internet of @ThingsExpo, Esmeralda Swartz, CMO of MetraTech, will discuss how for this to be effective you not only need to have infrastructure and operational models capable of utilizing this new phenomenon, but increasingly service providers will need to convince a skeptical public to participate. Get ready to show them the money! Speaker Bio: ...
Compute virtualization has been transformational, yet security policy implementation and enforcement has lagged behind in agility and automation. There are a number of key considerations when implementing policy in private and hybrid clouds. In his session at 15th Cloud Expo, Holland Barry, VP of Technology at Catbird, will discuss the impact of this new paradigm and what organizations can do today to safely move to software-defined network and compute architectures, including: How normal ope...
Samsung VP Jacopo Lenzi, who headed the company's recent SmartThings acquisition under the auspices of Samsung's Open Innovaction Center (OIC), answered a few questions we had about the deal. This interview was in conjunction with our interview with SmartThings CEO Alex Hawkinson. IoT Journal: SmartThings was developed in an open, standards-agnostic platform, and will now be part of Samsung's Open Innovation Center. Can you elaborate on your commitment to keep the platform open? Jacopo Lenzi: S...
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends: Exposing the device to a management framework Exposing that management framework to a business centric logic • Exposing that business layer and data to end users. This last trend is the IoT stack, which involves a new shift in the separation of what stuff hap...
SYS-CON Events announced today that SOA Software, an API management leader, will exhibit at SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. SOA Software is a leading provider of API Management and SOA Governance products that equip business to deliver APIs and SOA together to drive their company to meet its business strategy quickly and effectively. SOA Software’s technology helps businesses to accel...
SYS-CON Events announced today that Utimaco will exhibit at SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Utimaco is a leading manufacturer of hardware based security solutions that provide the root of trust to keep cryptographic keys safe, secure critical digital infrastructures and protect high value data assets. Only Utimaco delivers a general-purpose hardware security module (HSM) as a customiz...
Almost everyone sees the potential of Internet of Things but how can businesses truly unlock that potential. The key will be in the ability to discover business insight in the midst of an ocean of Big Data generated from billions of embedded devices via Systems of Discover. Businesses will also need to ensure that they can sustain that insight by leveraging the cloud for global reach, scale and elasticity.
SYS-CON Events announced today that ElasticBox is holding a Hackathon at DevOps Summit, November 6 from 12 pm -4 pm at the Santa Clara Convention Center in Santa Clara, CA. You can enter as an individual or team of up to 10 developers. A New Star Is Born Every Month! All completed ElasticBoxes will then be sent to a judging panel - 12 winners will be featured on the ElasticBox website in 2015. All entrants will receive five full enterprise licenses for one year + ElasticBox headphones + Elasti...
Once the decision has been made to move part or all of a workload to the cloud, a methodology for selecting that workload needs to be established. How do you move to the cloud? What does the discovery, assessment and planning look like? What workloads make sense? Which cloud model makes sense for each workload? What are the considerations for how to select the right cloud model? And how does that fit in with the overall IT tranformation? In his session at 15th Cloud Expo, John Hatem, head of V...
Cloud services are the newest tool in the arsenal of IT products in the market today. These cloud services integrate process and tools. In order to use these products effectively, organizations must have a good understanding of themselves and their business requirements. In his session at 15th Cloud Expo, Brian Lewis, Principal Architect at Verizon Cloud, will outline key areas of organizational focus, and how to formalize an actionable plan when migrating applications and internal services to...
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, will discuss how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP ...
Ixia develops amazing products so its customers can connect the world. Ixia helps its customers provide an always-on user experience through fast, secure delivery of dynamic connected technologies and services. Through actionable insights that accelerate and secure application and service delivery, Ixia's customers benefit from faster time to market, optimized application performance and higher-quality deployments.
SYS-CON Events announced today that Calm.io has been named “Bronze Sponsor” of DevOps Summit Silicon Valley, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Calm.io is a cloud orchestration platform for AWS, vCenter, OpenStack, or bare metal, that runs your CL tools puppet, Chef, shell, git, Jenkins, nagios, and will soon support New Relic and Docker. It can run hosted, or on premise and provides VM automation / expiry, self-service portals,...
In her General Session at 15th Cloud Expo, Anne Plese, Senior Consultant, Cloud Product Marketing, at Verizon Enterprise, will focus on finding the right mix of renting vs. buying Oracle capacity to scale to meet business demands, and offer validated Oracle database TCO models for Oracle development and testing environments. Anne Plese is a marketing and technology enthusiast/realist with over 19+ years in high tech. At Verizon Enterprise, she focuses on driving growth for the Verizon Cloud pla...
SYS-CON Events announced today that Aria Systems, the recurring revenue expert, has been named "Bronze Sponsor" of SYS-CON's 15th International Cloud Expo®, which will take place on November 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Aria Systems helps leading businesses connect their customers with the products and services they love. Industry leaders like Pitney Bowes, Experian, AAA NCNU, VMware, HootSuite and many others choose Aria to power their recurring revenue bu...
The Internet of Things (IoT) is going to require a new way of thinking and of developing software for speed, security and innovation. This requires IT leaders to balance business as usual while anticipating for the next market and technology trends. Cloud provides the right IT asset portfolio to help today’s IT leaders manage the old and prepare for the new. Today the cloud conversation is evolving from private and public to hybrid. This session will provide use cases and insights to reinforce t...
As Platform as a Service (PaaS) matures as a category, developers should have the ability to use the programming language of their choice to build applications and have access to a wide array of services. Bluemix is IBM's open cloud development platform that enables users to easily build cloud-based, creative mobile and web applications without having to spend large amounts of time and resources on configuring infrastructure and multiple software licenses. In this track, you will learn about the...
Blue Box has closed a $10 million Series B financing. The round was led by a strategic investor and included participation from prior investors including Voyager Capital and Founders Collective, as well as the Blue Box executive team. This round follows a $4.3 million Series A closed in December of 2012 and led by Voyager Capital. In May of this year, the company announced general availability of its private cloud as a service offering, Blue Box Cloud. Since that release, the company has dem...
SYS-CON Events announced today that Verizon has been named "Gold Sponsor" of SYS-CON's 15th International Cloud Expo®, which will take place on November 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Verizon Enterprise Solutions creates global connections that generate growth, drive business innovation and move society forward. With industry-specific solutions and a full range of global wholesale offerings provided over the company's secure mobility, cloud, strategic network...
SimpleECM is the only platform to offer a powerful combination of enterprise content management (ECM) services, capture solutions, and third-party business services providing simplified integrations and workflow development for solution providers. SimpleECM is opening the market to businesses of all sizes by reinventing the delivery of ECM services. Our APIs make the development of ECM services simple with the use of familiar technologies for a frictionless integration directly into web applicat...