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Submission includes data from three Phase III studies in over 1,000
patients from 23 countries
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Represents Sepracor’s first NDS in Canada since strategic acquisition
of Oryx Pharmaceuticals in June 2008
Sepracor
Inc. (Nasdaq: SEPR) today announced that its Canadian subsidiary, Sepracor
Pharmaceuticals, Inc. (SPI; formerly Oryx Pharmaceuticals, Inc.),
has submitted an application to the Therapeutic Products Directorate
(TPD) of Health Canada for eslicarbazepine acetate as adjunctive therapy
in the treatment of partial-onset seizures in adults with epilepsy. The
proposed trade name for eslicarbazepine acetate in both the U.S. and
Canada is STEDESA™.
“The STEDESA submission represents SPI’s continuing commitment to
providing Canadians with important new therapies in the treatment of
central nervous system disorders, which is a therapeutic area in which
we already have commercial experience,” said Douglas Reynolds, President
of Sepracor Pharmaceuticals, Inc. “If approved by Health Canada, STEDESA
has the near-term potential to be an important new treatment option for
patients suffering with epilepsy.”
STEDESA, a new chemical entity, is a novel voltage-gated sodium channel
blocker that has been designed to reduce the frequency of partial-onset
seizures.
“This NDS is our first submission in Canada since our strategic
acquisition of Oryx Pharmaceuticals in June of last year, and we are
very pleased to take this important step in what we hope to be the first
of several submissions to Health Canada in the coming years,” said
Adrian Adams, President and Chief Executive Officer of Sepracor. “This
advancement follows our recent New Drug Application submission for
STEDESA in the United States and is a manifestation of the value of the
successful corporate development and licensing initiatives that Sepracor
has executed to date.”
Under Health Canada’s Food and Drugs Act and Regulations, the TPD has 45
days in which to screen the submission to determine whether it is
complete and of suitable quality to be reviewed.
Sepracor submitted its NDA for STEDESA to the U.S. Food and Drug
Administration (FDA) in March 2009 for adjunctive therapy in the
treatment of partial-onset seizures in adults with epilepsy, and the FDA
accepted the filing for formal review in June 2009. The Prescription
Drug User Fee Act (PDUFA) action date for STEDESA in the U.S. is January
30, 2010. A PDUFA date is the date by which the FDA is expected to
review and act on an NDA submission.
BIAL-Portela & Ca, S.A. (BIAL), a privately held
Portuguese pharmaceutical company, was responsible for the research and
development of eslicarbazepine acetate. Sepracor acquired the rights to
commercialize eslicarbazepine acetate for the U.S. and Canadian markets
from BIAL in late 2007.
About STEDESA
STEDESA has been studied in three Phase III, multi-center, randomized,
placebo-controlled trials, which involved more than 1,000 patients from
23 countries.
