Sunovion Pharmaceuticals Canada Inc. Announces the Launch of Once-Daily LATUDA™ (lurasidone HCl) for the Treatment of Patients with Schizophrenia

MISSISSAUGA, ON, Sept. 17, 2012 /CNW/ - Sunovion Pharmaceuticals Canada Inc. today announced that LATUDA™ (lurasidone HCl) tablets, a once-daily atypical antipsychotic agent indicated for acute treatment of adult patients with schizophrenia is now available by prescription in pharmacies across Canada. LATUDA was approved by Health Canada on June 13, 2012 and is available in 40 mg, 80 mg and 120 mg tablets. LATUDA has been evaluated in 48 clinical studies involving more than 2,900 lurasidone-treated subjects.

"Schizophrenia is a devastating disease for those who suffer from it, and deeply affects their families as well," said Dr. Ruth Baruch, Medical Director of Community Programs, Department of Psychiatry, Toronto East General Hospital. "The availability of LATUDA will provide physicians with an important new treatment option to help manage the illness and assist in improving the quality of life for individuals with schizophrenia."

The efficacy of LATUDA was established in five, 6 week placebo controlled studies of adult patients with schizophrenia. In these studies, LATUDA demonstrated significantly greater improvement versus placebo on primary efficacy measures [change from baseline in Positive and Negative Syndrome Scale (PANSS) total score and Brief Psychiatric Scale-derived from PANNS (BPRSd)] at study endpoint. The most common adverse events in patients treated with LATUDA were nausea, somnolence, akathisia and parkinsonism.

"LATUDA is an important product for our company and we are excited to offer this new treatment option to physicians caring for adult patients with schizophrenia," said Douglas Reynolds, President, Sunovion Pharmaceuticals Canada Inc.

About Schizophrenia

Schizophrenia is a chronic, disabling disorder that is characterized by symptoms such as hallucinations, delusions, disorganized thinking, lack of emotion, lack of energy, as well as problems with memory, attention and the ability to plan, organize and make decisions.  This disease affects approximately one percent of the population, which translates to more than 335,000 Canadians.  The goal of treatment is to reduce symptoms, achieve stability, and facilitate illness improvement.  While there are several treatment options available, each patient responds to their medications differently.  A key obstacle is the ability to tolerate medications and unfortunately treatment discontinuation in this disease is as high as 40-50%2. Discontinuation is only partly due to intolerability; lack of efficacy plays a large role. Effective treatment for each patient requires the right balance of efficacy, safety and tolerability.

About LATUDA

LATUDA (lurasidone HCl) is a new medication in the atypical antipsychotic class that has been approved by Health Canada for the acute treatment of adult patients with schizophrenia. 

LATUDA has been studied in 48 clinical studies involving more than 2,900 lurasidone-treated subjects. The efficacy of LATUDA was demonstrated in five, 6 week placebo-controlled studies, involving hospitalized patients with schizophrenia. The efficacy of LATUDA for long-term use, that is, for more than 6 weeks, has not been systemically evaluated in controlled studies.  LATUDA was associated with low rates of change in metabolic parameters versus placebo. The most common adverse events in patients treated with LATUDA were nausea, somnolence, akathisia and parkinsonism.

For Important Information Concerning LATUDA go to www.sunovion.ca

  About Sunovion Pharmaceuticals Canada Inc.

Sunovion Pharmaceuticals Canada Inc. is focused on the development and commercialization of prescription products in Canada. In addition to commercializing Sunovion Pharmaceuticals Inc.'s products, our strategy is to license pharmaceutical products that meet the needs of patients and the Canadian health care system, currently focusing on cardiovascular disease, infectious disease and central nervous system (CNS) disorders.  More information about Sunovion Pharmaceuticals Canada Inc. is available at www.sunovion.ca

Sunovion Pharmaceuticals Canada Inc., a subsidiary of the U.S. based Sunovion Pharmaceuticals Inc., is headquartered in Mississauga, Ontario. Sunovion Pharmaceuticals Inc., an indirect, wholly-owned subsidiary of Dainippon Sumitomo Pharma Co., Ltd., is headquartered in Marlborough, Mass.  More information about Sunovion Pharmaceuticals Inc. is available at www.sunovion.com.

About Dainippon Sumitomo Pharma Co., Ltd. (DSP)

DSP is a multi-billion dollar, top-ten listed pharmaceutical company in Japan with a diverse portfolio of pharmaceutical, animal health and food and specialty products. DSP aims to produce innovative pharmaceutical products in the CNS field, which has been designated as the key therapeutic area and will also focus in on other specialty disease categories with significant unmet medical needs, which are designated as frontier therapeutic areas. DSP is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, DSP has more than 7,000 employees worldwide. Additional information about DSP is available through its corporate website at www.ds-pharma.com.

LATUDA is a registered trademark of Dainippon Sumitomo Pharma Co., Ltd.


1 Public Health Agency of Canada, Available at: http://www.phac-aspc.gc.ca/publicat/miic-mmac/chap_3-eng.php. Accessed June 11, 2012.
2 IMS Brogan, March 2012

For a copy of this release or any recent release, visit Sunovion's web site at www.sunovion.ca

SOURCE: Sunovion Pharmaceuticals Canada Inc.

For further information:

Douglas Reynolds
President
Sunovion Pharmaceuticals Canada Inc.
905-814-9145
douglas.reynolds@sunovion.com 

Patricia Moriarty
Senior Director, Corporate Communications
Sunovion Pharmaceuticals Inc.
508-787-4279
patricia.moriarty@sunovion.com

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Sunovion Pharmaceuticals Canada Inc.

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