Sunovion Pharmaceuticals Canada Inc. Announces Health Canada Approval of APTIOM(TM) (eslicarbazepine acetate) as a Once-Daily A

Sunovion Pharmaceuticals Canada Inc. Announces Health Canada Approval of 
APTIOM(TM) (eslicarbazepine acetate) as a Once-Daily Adjunctive Treatment for 
Partial-Onset Seizures in Patients with Epilepsy 
MISSISSAUGA, ON, July 11, 2014 /CNW/ - Sunovion Pharmaceuticals Canada Inc. 
(Sunovion) today announced that Health Canada approved APTIOM(TM) 
(eslicarbazepine acetate) for use as a once-daily adjunctive therapy for the 
treatment of partial-onset seizures in patients with epilepsy who are not 
satisfactorily controlled with conventional therapy.  APTIOM(TM) is not 
indicated for use in patients under 18 years of age. 
Epilepsy is one of the most common neurological disorders and according to 
Epilepsy Canada, it affects 0.6% of the population and each year approximately 
15,500 people learn they have epilepsy.  Partial-onset seizures are the most 
prevalent seizure type, accounting for 60% of new epilepsy diagnoses(1) and 
approximately one third of patients do not have adequate seizure control(5). 
The approval of APTIOM(TM) is based on three Phase 3 randomized, double-blind, 
placebo-controlled, safety and efficacy trials (Studies BIA-2093-301, 
BIA-2093-302 and BIA-2093-304), which included more than 1,400 people living 
with partial-onset seizures inadequately controlled by one to three 
concomitant AEDs (including carbamazepine, lamotrigine, valproic acid and 
levetiracetam). In these global studies,  treatment with APTIOM(TM) 
demonstrated statistically significant reductions in standardized seizure 
frequency versus placebo, and significantly more APTIOM(TM) treated patients 
experienced seizure frequency reduction of 50% or more from baseline (41% 
compared to 22% for placebo-treated patients). 
The most frequently reported adverse reactions in patients taking APTIOM(TM) 
were dizziness, somnolence, headache, nausea, diplopia, vomiting, fatigue, 
ataxia, vision blurred, and vertigo. 
"The approval of APTIOM(TM )is an important milestone not only for our 
company, but for thousands of Canadians living with, and affected by 
epilepsy." said Douglas Reynolds, President, Sunovion Pharmaceuticals Canada 
Inc.."Adequate seizure control remains an unmet medical need for a significant 
number of patients and Sunovion is committed to providing a treatment option 
to address this need." 
About Partial-Onset Seizures Epilepsy is a chronic neurological condition 
characterized by recurrent seizures resulting from abnormal firing of impulses 
from nerve cells in the brain(2). In partial-onset seizures, these bursts of 
electrical activity are initially focused in specific areas of the brain, but 
may become more widespread, with symptoms varying according to the affected 
areas(3,4). 
About APTIOM(TM )APTIOM(TM), a voltage-gated sodium channel inhibitor, is a 
prescription medicine approved for use as adjunctive treatment of 
partial-onset seizures. Treatment with APTIOM(TM) should be initiated at 400 
mg once daily. After one week, dosage may be increased to the recommended 
maintenance dosage of 800 mg once daily. Some patients may benefit from the 
maximum recommended maintenance dosage of 1,200 mg once daily, although this 
dosage is associated with an increase in adverse reactions. The maximum dose 
of 1,200 mg daily should only be initiated after the patient has tolerated 800 
mg daily for at least a week. For some patients, treatment may be initiated at 
800 mg once daily if the need for additional seizure reduction outweighs an 
increased risk of adverse reactions during initiation.  The initial research 
and development of eslicarbazepine acetate was performed by BIAL, a privately 
held Portuguese research-based pharmaceutical company. Subsequently, Sunovion 
acquired the rights under an exclusive license to further develop and 
commercialize eslicarbazepine acetate in the U.S. and Canadian markets from 
BIAL. Eslicarbazepine acetate was approved on November 8, 2013, by the U.S. 
FDA as adjunctive treatment of partial-onset seizures. 
In February 2009, Eisai Europe Limited, a European subsidiary of Eisai Co., 
Ltd. (Eisai), entered into a license and co-promotion agreement with BIAL, 
which gave the rights to Eisai to sell eslicarbazepine acetate under the trade 
name Zebinix(® )in Europe. Zebinix(®) was approved by the European 
Commission on April 21, 2009 as adjunctive therapy in adult patients with 
partial-onset seizures with or without secondary generalization and is 
currently marketed in Europe under the agreement. 
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 Sumitomo 
Dainippon Pharma Co., Ltd., is headquartered in Marlborough, Mass.  More 
information about Sunovion Pharmaceuticals Inc. is available at 
www.sunovion.com. 
About Sumitomo Dainippon Pharma Co., Ltd.   Sumitomo Dainippon Pharma is a 
top-ten listed pharmaceutical company in Japan with a diverse portfolio of 
pharmaceutical, animal health and food and specialty products. Sumitomo 
Dainippon Pharma aims to produce innovative pharmaceutical products in the 
Psychiatry & Neurology area and the Oncology area, which have been designated 
as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the 
merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo 
Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about 7,000 
employees worldwide. Additional information about Sumitomo Dainippon Pharma is 
available through its corporate website at www.ds-pharma.com. 
APTIOM is under license from BIAL. 
1.     http://www.epilepsy.ca/en-CA/Facts/Epilepsy-Facts.html 2.     
http://www.ninds.nih.gov/disorders/eplilepsy/epilpesy.htm 3.     
http://www.epilepsyfoundation.org/aboutepilepsy/seizures/partialseizures/index.
cfm 4.     http://www.dartmouth.edu/~dons/part_3/chapter_22.html 5.     Kwan 
P, Brodie MJ. N Eng J Med. 2000; 342:314-319 
For a copy of this release or any recent release, visit Sunovion's web site at 
www.sunovion.ca
 

SOURCE  Sunovion Pharmaceuticals Canada Inc. 
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 
To view this news release in HTML formatting, please use the following URL: 
http://www.newswire.ca/en/releases/archive/July2014/11/c3538.html 
CO: Sunovion Pharmaceuticals Canada Inc.
ST: Ontario
NI: HEA BTC MTC NP  
-0- Jul/11/2014 13:00 GMT
 
 
Press spacebar to pause and continue. Press esc to stop.