Healthcare Industry News:  arformoterol 

Biopharmaceuticals Regulatory

 News Release - July 27, 2007

Sepracor Submits LUNIVIA(R) (LUNESTA(R) in U.S.) Marketing Authorization Application (MAA) for Europe

Submission to European Medicines Agency (EMEA) Earlier Than Expected

MAA Includes Eszopiclone Co-Morbidity Data Comprised of Studies in Patients with Insomnia and Co-Morbid Depression, Generalized Anxiety Disorder, Rheumatoid Arthritis, and in Women in Menopausal Transition

MAA Includes Two Six-Month, Placebo-Controlled Eszopiclone Studies

European Union (EU) Approval Targeted for Second Half of 2008

European Insomnia Market Estimated at Approximately $500 Million in 2006


MARLBOROUGH, Mass.--(HSMN NewsFeed)--Sepracor Inc. (Nasdaq: SEPR ) today announced that it has submitted an MAA for LUNIVIA® brand eszopiclone to the EMEA for review under the centralized procedure. This procedure provides for a single, coordinated technical review that is conducted by the EMEA on behalf of all EU member states, using experts from national authorities as lead reviewers. Eszopiclone, which is known in the U.S. as LUNESTA®, is indicated in the U.S. for the treatment of insomnia. Approval of the MAA, which is the EU equivalent of a New Drug Application (NDA) that is reviewed by the U.S. Food and Drug Administration to determine if a pharmaceutical product should be approved for marketing in the U.S., would allow authorization to market LUNIVIA in as many as 27 EU member countries.

"We are extremely pleased to have submitted our MAA for eszopiclone in the EU, a market with significant opportunity for a potentially differentiated insomnia treatment. This is the second major milestone in our geographic expansion strategy outside of the U.S. for the LUNESTA franchise," said Adrian Adams, President and Chief Executive Officer of Sepracor. "This initiative represents another integral part of the next phase of growth for Sepracor, a phase that not only involves fully leveraging our product franchises, but also growing our research and development pipeline and aggressively pursuing synergistic corporate development and licensing opportunities."

"The EMEA's acceptance of our full clinical trial data set, which is nearly double the size of the data set previously submitted as part of the U.S. NDA, allows us to expedite our regulatory strategy in Europe," said Mark H.N. Corrigan, M.D., Executive Vice President of Research and Development at Sepracor. "We are especially pleased by the EMEA's interest in evaluating data from our studies of LUNESTA with long-term use and in patients with insomnia and co-morbid conditions. These studies are included in the MAA as support for use of LUNIVIA as a treatment for insomnia in specific patient populations."

Included in the MAA were results from 122 preclinical and 35 clinical studies. These studies included more than 5,500 adult and older adult (>65 years of age) subjects, including patients with transient or chronic insomnia. In addition to the studies of LUNESTA in patients with insomnia and co-existing conditions, two six-month, placebo-controlled studies in primary insomnia, as well as two driving studies that Sepracor believes will support a European labeling claim that LUNIVIA shows no effect on next-day driving (as measured by brake reaction time) in healthy subjects or subjects with insomnia, were included as part of the submission.

Sepracor has also commenced enrollment of its Pan-European six-month study of eszopiclone co-administered with EFFEXOR XR® (venlafaxine HCl) in subjects with insomnia and co-existing Major Depressive Disorder. This 640-patient trial seeks to assess the potential benefit of eszopiclone in reduction of symptoms of depression and in relapse prevention.

LUNESTA has been commercially available in the U.S. since 2005 for the treatment of insomnia and had product revenues of approximately $566.8 million in 2006. In 2006, the sedative hypnotic market in Europe was estimated to be approximately $500 million.

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 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 and BROVANA(TM) brand arformoterol tartrate Inhalation Solution. 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 to the safety, efficacy and potential benefits of LUNESTA brand eszopiclone; timing and success of regulatory approvals; possible approval for use of LUNIVIA to treat insomnia in specific patient populations; and the ability of Sepracor to leverage its product franchises. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the timing and success of submission, acceptance, and approval of regulatory filings; Sepracor's ability to fund, and the results of, further clinical trials; changes in the use and/or label of LUNESTA brand eszopiclone in the United States; the clinical benefits and safety of eszopiclone; the scope of Sepracor's patents and the patents of others; the commercial success of LUNESTA; the ability of the company to attract and retain qualified personnel; and certain other factors that are detailed in the company's quarterly report on Form 10-Q for the quarter ended March 31, 2007 filed with the Securities and Exchange Commission.

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.

Brovana is a trademark and Lunesta, Lunivia, Xopenex and Xopenex HFA are registered trademarks of Sepracor Inc. Effexor XR is a registered trademark of Wyeth Pharmaceuticals Inc. For a copy of this release or any recent release, visit Sepracor's

web site at www.sepracor.com.


Source: Sepracor

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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