European Medicines Agency (EMEA) Issues Positive Opinion For LUNIVIA(R) (Eszopiclone) Marketing Authorization Application (MAA) In Europe
Sepracor Inc. (Nasdaq: SEPR) today announced that the EMEA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending to grant a marketing authorization for LUNIVIA(R) brand eszopiclone in the European Union (EU) for the treatment of insomnia. The EU labeling provides for patients who require longer-term therapy to be treated for up to six months, with the usual course of therapy for typical patients being short-term. LUNIVIA is marketed in the U.S. under the brand name LUNESTA(R).
“We are pleased with the CHMP’s decision to support approval of LUNIVIA in the EU, a decision that we feel reflects the regulatory agency’s satisfaction with the quality, safety and efficacy of the product in both the short and long-term treatment of insomnia,” said Adrian Adams, President and Chief Executive Officer at Sepracor. “However, we are considering requesting a re-examination of the opinion relating to the exclusion of a new active substance designation that we feel would enable more favorable commercialization of the product.”
Sepracor entered into an agreement in September 2007 with GlaxoSmithKline (GSK) for worldwide (excluding North America and Japan) commercialization of eszopiclone for the treatment of insomnia.
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(R) brand eszopiclone, XOPENEX(R) brand levalbuterol HCl Inhalation Solution, XOPENEX HFA(R) brand levalbuterol tartrate Inhalation Aerosol, BROVANA(R) brand arformoterol tartrate Inhalation Solution, OMNARIS(TM) brand ciclesonide Nasal Spray and ALVESCO(R) brand ciclesonide HFA Inhalation Aerosol. Sepracor’s corporate headquarters are located in Marlborough, Massachusetts.
Lunivia, Lunesta, Xopenex, Xopenex HFA and Brovana are registered trademarks of Sepracor Inc. Omnaris is a trademark and Alvesco is a registered trademark of Nycomed GmbH. For a copy of this release or any recent release, visit Sepracor’s web site at www.sepracor.com.