Sepracor to Present New STEDESA™ Clinical Data at American Epilepsy Society Annual Meeting

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sepracor Inc. today announced that clinical study data for STEDESA^™ (eslicarbazepine acetate) will be presented at the 2009 annual meeting of the American Epilepsy Society (AES) in Boston. Seven posters describing new safety analyses will be presented at the Hynes Convention Center during the formal poster session on Saturday, December 5, 2009 between 1:00 pm and 8:00 pm EST. A separate Scientific Exhibit of STEDESA data will be held on Monday, December 7, 2009 from 8:00 am to 5:00 pm EST at the Sheraton Boston Hotel in Ballroom C and will include the posters presented during the poster session as well as additional posters of pharmacokinetic, safety and efficacy data and design posters for two ongoing trials.

Saturday, December 5, 2009 Poster Session:

• An Investigation of the Effects of Eslicarbazepine Acetate on Hyponatremia: A Pooled Analysis of Three Double-Blind Phase III Clinical Studies
• An Investigation of the Effect of Eslicarbazepine Acetate on Cardiac Repolarization: A Pooled Analysis of Over-Read Electrocardiograms From Three Double-Blind Phase III Clinical Studies
• An Evaluation of the Effect of Eslicarbazepine Acetate on Metabolic Parameters: A Pooled Analysis of Three Double-Blind Phase III Clinical Studies
• An Evaluation of Depressive Symptoms Following Treatment With Eslicarbazepine Acetate: A Pooled Analysis in the Open-Label Extensions of Three Phase III Studies in Subjects With Partial-Onset Seizures
• Incidence of Rash in the Pooled Population of Three Placebo-Controlled Phase III Clinical Trials With Eslicarbazepine Acetate
• An Investigation of the Therapeutic Effect of Eslicarbazepine Acetate Combined With Carbamazepine: Pooled Analysis of Three Placebo-Controlled Phase III Clinical Studies
• An Investigation of the Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Carbamazepine: A Pooled Analysis of the Three Placebo-Controlled Phase III Clinical Studies

Monday, December 7, 2009 Scientific Exhibit:

• Investigation of the Influence of Eslicarbazepine Acetate on the Plasma Concentrations of Concomitant Antiepileptic Drugs in Patients With Partial-Onset Epilepsy
• Pharmacokinetics of Eslicarbazepine Acetate in Subjects With Renal Impairment
• Effect of Eslicarbazepine Acetate on the Steady-State Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Subjects
• A Double-Blind, Add-On, Placebo-Controlled, Exploratory Trial of Eslicarbazepine Acetate in Patients With Partial-Onset Seizures
• An Evaluation of the Efficacy and Safety of Eslicarbazepine Acetate (ESL) as Add-On Treatment in Adults With Refractory Partial-Onset Seizures: Study BIA-2093-301
• Long-Term Treatment of Partial-Onset Seizures With Eslicarbazepine Acetate (ESL): Results of a One-Year Open-Label Extension to Study BIA-2093-301
• Assessment of Quality-of-Life and Depressive Symptoms During Long-Term Treatment With Eslicarbazepine Acetate: Study BIA-2093-301
• Evaluation of Efficacy and Safety of Eslicarbazepine Acetate (ESL) as Add-On Treatment in Adults With Refractory Partial-Onset Seizures: Study BIA-2093-302
• Long-Term Treatment of Partial-Onset Epilepsy With Eslicarbazepine Acetate (ESL): Results of a One-Year Open-Label Extension of Study BIA-2093-302
• Assessment of Quality-of-Life and Depressive Symptoms During Long-Term Treatment With Eslicarbazepine Acetate: Study BIA-2093-302
• Evaluation of the Efficacy and Safety of Eslicarbazepine Acetate as Add-On Treatment in Patients With Partial-Onset Seizures: Pooled Analysis of Three Double-Blind Phase III Clinical Studies
• Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures in a Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial
• Sepracor Study 093-045 Design Overview: Double-Blind, Randomized, Historical Control Study of Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current AEDs

The studies on which these analyses and posters are based were conducted by BIAL with editorial support for the posters provided by Sepracor.

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.¹ 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.² Patient compliance with antiepileptic agents represents a significant area of unmet need, with poorly compliant patients more likely to have breakthrough seizures³ and have higher mortality risk⁴. Additionally, patients with epilepsy often suffer from other concomitant diseases, further complicating the management of these patients.⁵ Finally, certain adverse events are highly prevalent with antiepileptic agents and may affect as many as 97% of patients.⁶

Epilepsy is characterized by abnormal firing of impulses from nerve cells in the brain. In partial-onset seizures, 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 STEDESA

STEDESA is under U.S. Food and Drug Administration (FDA) review as an adjunctive treatment of partial-onset seizures in adult patients with epilepsy. The Prescription Drug User Fee Act (PDUFA) date for STEDESA is January 30, 2010. A PDUFA date is the date by which the FDA is expected to review and act on a New Drug Application (NDA) submission.

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 & C^a, 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 Sepracor

Sepracor Inc., an indirect, wholly owned subsidiary of Dainippon Sumitomo Pharma Co., Ltd., 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.

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

² Brodie MJ. Management strategies for refractory localization-related seizures. Epilepsia 2001;42(Suppl 3):27-30

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

⁴ 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

⁵ 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

⁶ 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 & C^a, S.A. OMNARIS and ALVESCO are registered trademarks of Nycomed GmbH.

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