First Country in Europe Launches LATUDA® (lurasidone) - a New Atypical Antipsychotic for Adults with Schizophrenia

    First Country in Europe Launches LATUDA® (lurasidone) - a New Atypical
                 Antipsychotic for Adults with Schizophrenia

Swiss launch marks the first step towards lurasidone becoming available across
Europe

  PR Newswire

  ZURICH, September 10, 2013

ZURICH, September 10, 2013 /PRNewswire/ --

LATUDA ^® (lurasidone), a new once-daily treatment for schizophrenia, is now
available in Switzerland for the treatment of schizophrenia. ^[1] Research has
shown that the atypical antipsychotic, lurasidone, has a specific receptor
binding profile. ^[2]

Symptom control and reducing relapse are primary goals of schizophrenia
therapy. ^[3] Lurasidone has been shown in clinical trials to offer both short
and long-term efficacy with a rapid onset of action that has demonstrated
effective symptom control as early as day four of treatment. ^[4] It has also
been shown to offer consistency of response across efficacy measures of
schizophrenia symptoms. ^[5]

In addition to effective symptom control, it is important to minimize the
effect of treatment on long-term physical health as patients are likely to
need to remain on therapy for many years. Research has shown that there can be
associated problematic side effects such as weight gain and cholesterol
increases with schizophrenia treatments - both of which can lead to metabolic
and cardiovascular concerns in the longer term. ^[6] Recent research has shown
that lurasidone has a combination of efficacy and a favourable side effect
profile ^[7] which may help patients maintain their cardiometabolic health and
thereby improve their outcomes in the long term. 

"As a committed psychiatrist, I am interested in new, effective agents for the
treatment of severely ill patients with mental disorders. This is particularly
true for patients who are not suitable for or not responded to currently
approved therapeutics. We need effective, well-tolerated and metabolically
neutral alternatives, which can also be used in young patients. Lurasidone has
an interesting profile of action," says Dr Philipp Eich, Stv Chefarzt,
Kantonale Psychiatrische Klinik Liestal, Switzerland.

Schizophrenia affects around 80,000 people in Switzerland and can affect both
men and women, with symptoms emerging in early adulthood. ^[ ^8 ^] As a
severe, chronic mental illness, the course of schizophrenia varies, but it is
generally characterized by psychotic episodes, with underlying negative and
cognitive symptoms and incomplete recovery between episodes. ^[8] Symptoms of
the condition can include so-called positive symptoms such as delusions, ^[ ^8
^] hallucinations, ^[ ^8 ^] reality distortion ^[ ^8 ^] and so-called negative
symptoms such as, blunted affect, emotional and social withdrawal/drive. ^[ ^8
^]

" Today is an important landmark for  Takeda  in Europe as it marks our
first launch  of a  medicine  from  our  emerging  CNS portfolio -
lurasidone is an important driver in  our  initiatives to expand the
franchise for specialty care in  Europe .  We have a broad range  of 
medicines in development in  significant  areas of unmet clinical need  and
we look forward to bringing innovative treatments to market that bring benefit
s to the  wide st  range of patients  possible, " said Rene Gilvert, Vice
President Global Marketing and Therapeutic Area Lead CNS, Takeda
Pharmaceuticals International.

Takeda has also submitted a marketing authorization application (MAA) for
lurasidone in October 2012 to the European Medicines Agency (EMA). Takeda will
communicate the outcome of this application in the coming months.

About Lurasidone

Lurasidone is an atypical antipsychotic indicated for the treatment of
patients with schizophrenia. The effectiveness and efficacy of lurasidone for
longer-term use (for more than six weeks), has also been established in
controlled studies. ^[9] , ^[10]

Lurasidone has been licensed in Switzerland for the treatment of
schizophrenia. Lurasidone was created and developed by Dainippon Sumitomo
Pharma Co. Ltd. and received FDA approval in October 2010 and has been
available in the US since 2011. It was also approved by Health Canada for
adults with schizophrenia in August 2011.

Please see important safety information including the black triangle
information and full prescribing information at Latuda Fachinformation,
http://www.swissmedicinfo.ch

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. ^[11] ,
^[12] , ^[13] , ^[14]

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. ^[15] Switching antipsychotic medication is common in the
treatment of patients with schizophrenia either due to residual or emergent
symptoms, adverse events or tolerability issues. ^[16] ^, ^[17]

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. ^[18]
^, ^[19] Hospitalization associated with patient relapse can significantly
increase costs associated with disease management in schizophrenia. ^[20]

About Takeda Pharmaceuticals International GmbH

Takeda Pharmaceuticals International GmbH, headquartered in Zurich, is a
wholly owned subsidiary of Takeda Pharmaceutical Company Limited. As the
largest pharmaceutical company in Japan and a leader in the global industry,
Takeda's mission is to strive toward better health for patients worldwide
through leading innovation in medicine. It has a commercial presence covering
more than 70 countries, with particular strength in Asia, North America,
Europe and fast-growing emerging markets including Latin America, Russia-CIS
and China. Takeda is ranked 12th by global Rx sales, 14th in the BRIC
countries and 18th in Europe. Takeda's commercial presence mainly covers the
therapeutic areas of metabolic diseases, gastroenterology, oncology,
cardiovascular health, CNS diseases, inflammatory and immune disorders,
respiratory diseases and pain management.

Additional information about Takeda is available through its corporate
website, http://www.takeda.com .



References

1. Latuda Fachinformation, June. 2013, Takeda Pharma AG. Available from:
http://www.swissmedicinfo.ch

2. Ishibashi T. Pharmacological profile of lurasidone, a novel antipsychotic
agent with potent 5-hydroxytryptamine 7 (5-HT7) and 5-HT1A receptor activity.
J Pharmacol Exp Ther. 2010 Jul;334(1):171-81.

3. Ventura J et al. Remission and Recovery during the First Outpatient Year of
the Early Course of Schizophrenia. Schizophr Res 2011;132(1):18−23.

4. Swiss SmPC - June 2013

5. Nakamura M et al. Lurasidone in the Treatment of Acute Schizophrenia: A
Double-Blind, Placebo-Controlled Trial. J Clin Psychiatry 2009;70(6):829−836

6. Daumit GL et al. Antipsychotic effects on estimated 10-year coronary heart
disease risk in the CATIE schizophrenia study. Schizophr Res 2008
105(1-3):175−187.

7. Loebel et al. Effectiveness of lurasidone vs. quetiapine XR for relapse
prevention in schizophrenia: a 12-month, double-blind, noninferiority study.
Schizophrenia Research 2013 147 95-102.

8. Tandon RT et al. Schizophrenia, "just the facts" 4. Clinical features and
conc~ptualization. Schizophr Res 2009;110:1-23.

9. Citrome L et al. Int Clin Psychopharmacol 2012;27:165-76

10. Meltzer H et al. Lurasidone in the Treatment of Schizophrenia: A
Randomized, Double-Blind, Placebo- and Olanzapine- Controlled Study. Am J
Psychiatry 2011;168:957-67.

11. Healy D et al. Mortality in schizophrenia and related psychoses: data from
two cohorts, 1875-1924 and 1994-2010. BMJ Open 2012;2:e001810.

12. 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.

13. Laursen TM. Life expectancy among persons with schizophrenia or bipolar
affective disorder. Schizophr Res 2011;131:101-4.

14. Tiihonen J et al. 11 year-follow up of mortality in patients with
scizophrenia: a population-based cohort study (FINN11 study). Lancet
2009;374:620-7.

15. Lewis DA and Lieberman JA. Neuron 2000;28:325-34.

16. Faries DE et al. Clinical and economic ramifications of switching
antipsychotics in the treatment of schizophrenia. BMC Psych 2009;9:54.

17. Tsutsumi C et al. The evolution of antipsychotic switch and polypharmacy
in natural practice - A longitudinal perspective. Schizophr Res 2011;130:40-6.

18. Salize HJ et al. Cost of schizophrenia in six European countries.
Schizophr Res 2009;111(1-3):70-7.

19. Mangalore R and Knapp R. Cost of schizophrenia in England. J Ment Health
Policy Econ 2007;10(1):23-41.

20. 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.

Contact: Media Enquiry Contacts: Kate Burd, Takeda Pharmaceuticals
International GmbH, +44-7974-151510, Kate.burd@takeda.com ; Arran Attridge,
Red Door Communications, +44-7812-398-525, aattridge@rdcomms.com