Healthcare Industry News:  OMNARIS 

Biopharmaceuticals FDA

 News Release - December 17, 2009

Sepracor Granted Patent Term Extension for LUNESTA(R) and Provides Update on LUNESTA Pediatric Studies

LUNESTA patent term extended by 760 days to February 14, 2014

FDA lifts clinical hold on LUNESTA pediatric studies


MARLBOROUGH, Mass.--(HSMN NewsFeed)--Sepracor Inc. today announced that the United States Patent and Trademark Office has determined that U.S. Patent No. 6,444,673, which is a composition of matter patent that covers the human drug product LUNESTA(R) (eszopiclone), received a patent term extension under 35 U.S.C. 156. The period of extension was determined to be 760 days, and the new expiration date of the patent is February 14, 2014. LUNESTA is marketed by Sepracor for the treatment of insomnia. In addition, the exclusivity period could potentially be extended for an additional six months if Sepracor successfully obtains a pediatric exclusivity extension by submitting data developed in accordance with the pediatric Written Request.

In 2008 and early 2009, Sepracor completed two pediatric studies of LUNESTA in response to a Written Request from the U.S. Food and Drug Administration (FDA) in connection with its efforts to obtain pediatric exclusivity for LUNESTA. In April 2009, Sepracor initiated two additional pediatric studies in accordance with the FDAs Written Request. In July, the FDA notified Sepracor that it placed these two studies on clinical hold due to its concerns regarding non-clinical data that the FDA thought could be relevant to the administration of eszopiclone in children. The FDA recently informed Sepracor that the clinical hold placed on these LUNESTA pediatric studies has now been lifted. The company is in the process of determining the next steps for the trials.

About LUNESTA

LUNESTA(R) brand eszopiclone is a non-narcotic non-benzodiazepine indicated for the treatment of insomnia. Introduced in April 2005, LUNESTA allows patients to fall asleep quickly as well as sleep through the night and may be used by people experiencing transient insomnia as well as long-term by people with chronic insomnia.

For additional information about LUNESTA, please visit the LUNESTA product website at www.lunesta.com.

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, corporate development, and licensing efforts have 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(R) brand ciclesonide Nasal Spray and ALVESCO(R) brand ciclesonide HFA Inhalation Aerosol. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.

LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks of Sepracor Inc. OMNARIS and ALVESCO are registered trademarks of Nycomed GmbH.


Source: Sepracor

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