Sepracor Announces New Drug Submission (NDS) to Health Canada for STEDESA(TM) as Adjunctive Treatment for Epilepsy
Submission includes data from three Phase III studies in over 1,000 patients from 23 countries
Represents Sepracor's first NDS in Canada since strategic acquisition of Oryx Pharmaceuticals in June 2008
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Aug. 10, 2009-- 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 STEDESATM.
"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.
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 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.
Sepracor is seeking approval of STEDESA in the U.S. and Canada for adjunctive therapy with once-daily maintenance 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
According to the World Health Organization, an estimated 50 million people worldwide have epilepsy. 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.1 Patient compliance with antiepileptic agents represents a significant area of unmet need, with poorly compliant patients more likely to have breakthrough seizures2 and have higher mortality risk3. Additionally, patients with epilepsy often suffer from other concomitant diseases, further complicating the management of these patients.4 Finally, adverse events, such as dizziness and somnolence, are highly prevalent with existing antiepileptic agents and may affect as many as 97% of patients.5
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; the symptoms vary according to the affected areas. Nerve impulses are triggered via voltage-gated sodium channels in the nerve cell membrane.
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.
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy, potential benefits, possible uses and commercial success of STEDESA; STEDESA being the potential trade name for eslicarbazepine acetate in both the U.S. and Canada; STEDESA having the near-term potential to be an important new treatment option for patients suffering with epilepsy; and the potential for several NDS submissions to Health Canada in the coming years. 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 approval of the STEDESA NDA; the timing and success of acceptance and approval of the STEDESA NDS; the scope of Sepracor's trademarks, patents and the patents of others (including BIAL) and the success of challenges by others of Sepracor's and BIAL's patents; the clinical benefits and commercial success of Sepracor's products, including STEDESA; Sepracor's ability to continue to successfully implement its corporate restructuring and workforce reduction plan and further 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 June 30, 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.
1 Brodie MJ. Management strategies for refractory localization-related seizures. Epilepsia 2001;42(Suppl 3):27-30
2 Cramer JA, Glassman M, Rienzi V. The relationship between poor medication compliance and seizures. Epilepsy Behav. 2002;3:338-342
3 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
4 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
5 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.
For a copy of this release or any recent release, visit Sepracor's web site at www.sepracor.com.
Source: Sepracor Inc.
Jonaé R. Barnes, 508-481-6700
Sr. Vice President, Investor Relations and
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding Sepracor Inc.'s business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.