N e w s R e l e a s e
Sunovion Pharmaceuticals Canada Inc.
6790 Century Ave., Suite 100
Mississauga, ON L5N 2V8
Tel 905-814-9145
Contacts:
Douglas Reynolds
President
Sunovion Pharmaceuticals Canada Inc.
905-814-9145
douglas.reynolds@sunovion.com
Susan Adler Alesina
Vice President, Corporate Communications
Sunovion Pharmaceuticals Inc.
508-481-6700
susan.alesina@sunovion.com
Sunovion Pharmaceuticals Canada Inc. Announces Health Canada Acceptance of Lurasidone
New Drug Submission for Treatment of Schizophrenia
- NDS Included 48 Clinical Studies Involving More Than 2,900 Patients Treated With Lurasidone -
Mississauga, Ontario, August 23, 2011 – Sunovion Pharmaceuticals Canada Inc., formerly Sepracor Pharmaceuticals, Inc., today announced that the New Drug Submission (NDS) for Lurasidone HCl, for the treatment of adult patients with schizophrenia has been accepted for review by Health Canada. The NDS was submitted to Health Canada in June 2011 and will receive a standard review.
“We are pleased that the lurasidone NDS has been accepted for review by Health Canada,” said Douglas Reynolds, President, Sunovion Pharmaceuticals Canada Inc. “This acceptance marks a significant milestone for our company as we look to bring an innovative new treatment option for schizophrenia to patients, caregivers and healthcare professionals in Canada.”
The lurasidone NDS includes data from 48 clinical studies involving more than 2,900 lurasidone-treated patients. The efficacy of lurasidone was demonstrated in five six-week, placebo-controlled studies, involving hospitalized patients with schizophrenia. These studies included the three global PEARL (Program to Evaluate the Antipsychotic Response to Lurasidone) clinical trials. In clinical trials, lurasidone was tolerable and associated with low rates of change in metabolic parameters, including weight versus placebo. The most common adverse events associated with lurasidone are somnolence, akathisia, nausea, and parkinsonism.
Lurasidone is an atypical antipsychotic agent with a chemical structure that has high affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects. In addition, lurasidone is a partial agonist with moderate affinity at the serotonin 5-HT1A receptor. Lurasidone exhibits little or no affinity for histamine H1 and muscarinic M1 receptors.
Lurasidone is currently available in the United States and Puerto Rico under the brand name LATUDA® in 40 mg and 80 mg once-daily tablets.
About Schizophrenia
Schizophrenia is a chronic, disabling and serious brain disorder that affects approximately one percent of the Canadian population1 and more than 24 million adults worldwide. Schizophrenia 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.
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 7,000employees 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 July 26, 2011.
For a copy of this release or any recent release,
visit Sunovion’s web site at www.sunovion.ca
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