Sepracor`s STEDESA™ (Eslicarbazepine Acetate) New Drug Application Formally Accepted for Review by the FDA

* Reuters is not responsible for the content in this press release.

Mon Jun 1, 2009 7:00am EDT

-- Submission includes data from three Phase III studies in more than 1,000
patients from 23 countries

-- More than 3 million people in the U.S. are afflicted with epilepsy and
seizures1

-- U.S. epilepsy treatment market estimated to be $3.5 billion2
MARLBOROUGH, Mass.--(Business Wire)--
Sepracor Inc. (Nasdaq: SEPR) today announced that it has been notified by the
U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for
STEDESA™ (eslicarbazepine acetate) has been accepted for filing and is now under
formal review. As previously announced, the NDA for STEDESA was submitted to the
FDA on March 31, 2009 for adjunctive therapy in the treatment of partial-onset
seizures in adults with epilepsy. The acceptance of the filing means that the
FDA has made a threshold determination that the NDA is sufficiently complete to
permit a substantive review. 

The Prescription Drug User Fee Act (PDUFA) date for STEDESA is expected to be
January 30, 2010, subject to written confirmation. A PDUFA date is the date by
which the FDA is expected to review and act on an NDA submission. 

"We are very pleased to continue the advancement of STEDESA as a potential new
adjunctive treatment for partial-onset epilepsy," said Adrian Adams, President
and Chief Executive Officer of Sepracor. "STEDESA represents a significant and
near-term opportunity for Sepracor, and the FDA acceptance of the NDA is yet
another step forward in one of our near- and mid-term corporate objectives of
expanding and advancing our pharmaceutical product pipeline." 

STEDESA, a new chemical entity, is a novel voltage-gated sodium channel blocker.
STEDESA has been studied in three Phase III, multi-center, randomized,
placebo-controlled trials, which involved more than 1,000 patients from 23
countries. Patients involved in the trials had a history of at least four
partial-onset seizures per month despite treatment with one to three concomitant
antiepileptic drugs. During the trials, patients were randomized to
eslicarbazepine acetate or placebo, and after a 2-week titration period, were
assessed over a 12-week maintenance period with continued follow-up over a
one-year, open-label period. 

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
in the U.S. and Canadian markets from BIAL in late 2007. 

Sepracor is seeking approval of STEDESA for adjunctive therapy with once-daily
doses of 800 mg and 1200 mg in the treatment of partial-onset seizures in adults
with epilepsy. 

About partial-onset seizures and their treatment

Epilepsy is one of the most common neurological diseases that, according to the
Epilepsy Foundation, afflicts more than 3 million people in the United States.
Treatment of partial-onset seizures, the most common type of epilepsy, presents
a constant challenge - up to 58% of patients with partial-onset seizures do not
achieve seizure control with current antiepileptic drugs.3 Patient compliance
with antiepileptic agents represents a significant area of unmet need, with
poorly compliant patients more likely to have breakthrough seizures4 and have
higher mortality risk5. Additionally, patients with epilepsy often suffer from
other concomitant diseases, further complicating the management of these
patients.6 Finally, adverse events, such as dizziness and somnolence, are highly
prevalent with existing antiepileptic agents and may affect as many as 97% of
patients.7

Epilepsy is characterized by abnormal firing of impulses from nerve cells in the
brain. In partial-onset epilepsy, these bursts of electrical activity are
initially focused in specific areas of the brain, but may become more
generalized, with symptoms varying according to the affected areas. Nerve
impulses are triggered via voltage-gated sodium channels in the nerve cell
membrane. 

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 ciclesonideHFA 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 STEDESA; the expected January
30, 2010 PDUFA date for STEDESA; STEDESA representing a significant and
near-term opportunity for Sepracor; and the NDA application being a step forward
in meeting one of Sepracor`s near- and mid-term corporate objectives of
expanding and advancing its pharmaceutical product pipeline. Among the factors
that could cause actual results to differ materially from those indicated by
such forward-looking statements are: Sepracor`s ability to fund, and the results
of, further clinical trials; the timing and success of acceptance, and approval
of the STEDESA NDA and other regulatory filings; the scope of Sepracor's
trademarks, patents and the patents of others (including BIAL`s) and the success
of challenges by others of Sepracor's and BIAL`s patents; the clinical benefits
and commercial success of Sepracor`s (and its partners`) products; Sepracor`s
ability to successfully implement its recently announced corporate restructuring
and workforce reduction plan and reduce expenses; the ability of Sepracor to
attract and retain qualified personnel; the ability of Sepracor to successfully
collaborate with BIAL and other third parties and enter into new collaboration
arrangements; the performance of Sepracor's licensees and other collaboration
partners, including BIAL; 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, 2008 filed with the 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. 

1 The Epilepsy Foundation of America® web site
http://www.epilepsyfoundation.org/about/statistics.cfm, accessed May 27, 2009 

2 Source: IMS Health, Verispan 

3 Brodie MJ. Management strategies for refractory localization-related seizures.
Epilepsia 2001;42(Suppl 3):27-30 

4 Cramer JA, Glassman M, Rienzi V. The relationship between poor medication
compliance and seizures. Epilepsy Behav. 2002;3:338-342 

5 Faught E, Duh, M, Weiner J, Guerin A, Cunnington M. Nonadherence to
antiepileptic drugs and increased mortality, Findings from the RANSOM Study.
Neurology 2008; 71: 1572-1578 

6 Gidal BE, French JA, Grossman P, Le Teuff G. Assessment of potential drug
interactions in patients with epilepsy: Impact of age and sex. Neurology 2009;
72: 419-431 

7 Mei PA, Montenegro MA, Guerreiro MM, Guerreiro CA. Pharmacovigilance in
epileptic patients using antiepileptic drugs. Arq Neuropsiquiatr 2006
Jun;64(2A): 198-201. Epub 2006 Jun 9 

LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks of Sepracor
Inc. STEDESA is a trademark of BIAL-Portela & Ca, S.A. OMNARIS and ALVESCO are
registered trademarks of Nycomed GmbH. The Epilepsy Foundation of America is a
registered trademark of Epilepsy Foundation of America Corporation. 

For a copy of this release or any recent release, visit Sepracor`s web site at
www.sepracor.com. 





Sepracor Inc.
Jonaé R. Barnes, 508-481-6700
Sr. Vice President, Investor Relations and
Corporate Communications 



Copyright Business Wire 2009

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.