MARLBOROUGH, Mass.--(BUSINESS WIRE)--Jul. 1, 2009--
Sepracor Inc. (Nasdaq: SEPR) today announced that it has completed the
analysis and validation of the preliminary results of a Phase II,
514-patient study evaluating the efficacy and safety of SEP-225289 for
the treatment of Major Depressive Disorder, including patients with
melancholic and atypical features. Sepracor determined that SEP-225289
did not meet the primary efficacy endpoint, which was a reduction in
symptoms of depression following eight weeks of treatment, as assessed
using the clinician-rated, 17-item HAM-D scale (Hamilton Depression
Rating Scale, a standard scale used to assess depression in clinical
trials and consisting of a list of symptoms commonly associated with
depression). The positive control in the study (venlafaxine
extended-release) did achieve separation from placebo that was
statistically significant on the primary endpoint.
In this study, the measured serum concentrations of SEP-225289 were
found to be below expected levels of exposure for both doses studied and
were well below exposure profiles observed in several Phase I studies.
Further, the adverse event profile demonstrated by SEP-225289 was
inconsistent with prior clinical experience and was similar to the side
effect profile observed when patients were administered placebo. As
such, preliminary data are inconclusive pending further investigation of
the dose exposure relationship of SEP-225289.
“While we are clearly disappointed with the findings from the analysis
of the preliminary study results, we are in the process of further
analysis of the dose response and secondary endpoints to determine how
or if we will take this novel mechanistic approach forward,” said Mark
H.N. Corrigan, M.D., Executive Vice President, Research and Development
at Sepracor.
SEP-225289 is a member of a relatively new class of pharmacologic agents
referred to as triple reuptake inhibitors based on their activities at
the serotonin, norepinephrine and dopamine transporters. The
pharmacological profile of SEP-225289 is distinct from all other
currently approved antidepressant agents due to its significant affinity
for the dopamine transporter as well as its high potency reuptake
inhibition at the serotonin and norepinephrine transporters.
In 2008 and early 2009, Sepracor completed two pediatric studies of
LUNESTA® brand eszopiclone in response to a Written Request
from the United States Food and Drug Administration (FDA) in connection
with its efforts to obtain a pediatric exclusivity extension for
LUNESTA. In April 2009, Sepracor initiated two additional pediatric
studies in accordance with the FDA’s Written Request. The FDA has
notified us that these two studies have been put on clinical hold due to
its concerns regarding non-clinical data that could be relevant to the
administration of eszopiclone in children. The clinical hold does not
relate to any findings observed in the pediatric clinical studies nor
does it impact any ongoing eszopiclone clinical trials in adults. In
addition, this action does not impact the availability or prescribing
information for LUNESTA in the treatment of adults with insomnia.
LUNESTA has been proven to be safe and well tolerated in the treatment
of adults and elderly patients with insomnia. Sepracor intends to work
with the FDA to address the potential resolution of FDA’s concerns
regarding the non-clinical data with respect to human pediatric subjects.
“We are focusing our near-term research and development efforts on
STEDESA™, which is a potential new adjunctive treatment for
partial-onset epilepsy currently under review at the FDA, and OMNARIS®
HFA Nasal Aerosol for the treatment of allergic rhinitis, which is on
target to enter its second large-scale Phase III clinical study in the
fall of 2009,” said Adrian Adams, President and Chief Executive Officer
of Sepracor. “We will provide an update on the ongoing analysis of the
SEP-225289 data and the LUNESTA pediatric studies during our second
quarter 2009 conference call that will be held later in July. In
addition, we will provide a general review of progress with our
pharmaceutical product pipeline.”
About Sepracor
Sepracor Inc. is a research-based pharmaceutical company dedicated to
treating and preventing human disease by discovering, developing and
commercializing innovative pharmaceutical products that are directed
toward serving large and growing markets and unmet medical needs.
Sepracor's drug development program has yielded a portfolio of
pharmaceutical products and candidates with a focus on respiratory and
central nervous system disorders. Currently marketed products include
LUNESTA® brand eszopiclone, XOPENEX® brand
levalbuterol HCl Inhalation Solution, XOPENEX HFA® brand
levalbuterol tartrate Inhalation Aerosol, BROVANA® brand
arformoterol tartrate Inhalation Solution, OMNARIS® brand
ciclesonide Nasal Spray and ALVESCO® brand ciclesonide HFA
Inhalation Aerosol. Sepracor's corporate headquarters are located in
Marlborough, Massachusetts.
Forward-Looking Statement
This news release contains forward-looking statements that involve risks
and uncertainties, including statements with respect the safety,
efficacy, potential benefits, possible uses and commercial success of
SEP-225289, STEDESA and OMNARIS HFA Nasal Aerosol; Sepracor’s near-term
research and development efforts on STEDESA and OMNARIS HFA Nasal
Aerosol; the timing of the second large-scale Phase II clinical study
for OMNARIS HFA Nasal Aerosol; Sepracor’s further investigation of the
dose exposure relationship of SEP-225289 and secondary endpoints in the
Phase II study; and Sepracor’s ability to address FDA’s concerns
regarding the non-clinical data that could be relevant to the
administration of eszopiclone in children. Among the factors that could
cause actual results to differ materially from those indicated by such
forward-looking statements are: results from further analysis of the
SEP-225289 Phase II study, including dose response and secondary
endpoints; Sepracor’s ability to fund, and the results of, further
clinical trials; the timing and success of the development of OMNARIS
HFA Nasal Aerosol and the FDA’s review of the STEDESA New Drug
Application; the scope of Sepracor's and its collaboration partners’
trademarks, patents and the patents of others; the success of challenges
by others of Sepracor's and its collaboration partners’ patents; the
clinical benefits and commercial success of Sepracor’s and its
collaboration partners’ products; the ability of Sepracor to attract and
retain qualified personnel; the ability of Sepracor to successfully
collaborate with BIAL-Portela & Ca, S.A. (BIAL) and
Nycomed GmbH (Nycomed) for STEDESA and OMNARIS HFA Nasal Aerosol,
respectively; the performance of Sepracor's collaboration partners,
including BIAL and Nycomed; and certain other factors that may affect
future operating results, which are detailed in Sepracor’s Quarterly
Report on Form 10-Q for the quarter ended March 31, 2009 filed with the
Securities and Exchange Commission (SEC), and other reports filed with
the SEC.
In addition, the statements in this press release represent Sepracor's
expectations and beliefs as of the date of this press release. Sepracor
anticipates that subsequent events and developments may cause these
expectations and beliefs to change. However, while Sepracor may elect to
update these forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so. These forward-looking
statements should not be relied upon as representing Sepracor's
expectations or beliefs as of any date subsequent to the date of this
press release.
LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks of
Sepracor Inc. OMNARIS and ALVESCO are registered trademarks of Nycomed
GmbH. STEDESA is a trademark of BIAL-Portela & Ca, S.A.
For a copy of this release or any recent release,
visit Sepracor’s
web site at www.sepracor.com.
Source: Sepracor Inc.
Sepracor Inc.
Jonaé R. Barnes, 508-481-6700
Sr. Vice
President, Investor Relations and
Corporate Communications
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