MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sepracor Inc. (Nasdaq: SEPR - News) today announced that it has entered into a Settlement and License Agreement with Teva Pharmaceuticals USA, Inc. (Teva) and Barr Laboratories, Inc. (Barr), a wholly owned subsidiary of Teva, to resolve the patent litigation against Barr involving Sepracor’s XOPENEX® brand levalbuterol HCl Inhalation Solution products (1.25 mg/3 mL, 0.63 mg/3 mL and 0.31 mg/3 mL) and to grant a license to Barr and Teva. The agreement permits Barr and Teva to launch generic versions of these XOPENEX Inhalation Solution dosages under terms of a non-exclusive license commencing on February 17, 2013. The agreement also contains provisions whereby the effective date of Barr’s and Teva’s license can be earlier under certain circumstances. Upon launch, Teva and Barr will pay Sepracor a royalty on their respective profit margins generated from the sales of generic versions of these XOPENEX Inhalation Solution dosages. The parties agreed to promptly file a consent final judgment and dismissal in the United States District Court for the District of Delaware that will conclude this litigation.
“We are very pleased with the resolution of our patent infringement dispute with Barr and patent issues with Teva as it allows all parties to avoid the uncertainties and expenses related to patent litigation,” said Adrian Adams, President and Chief Executive Officer of Sepracor. “With the lawsuit and these patent issues behind us, Sepracor can continue to focus on fully leveraging each of our product franchises and advancing our research and development candidates.”
The settlement agreement is a final settlement of the Barr litigation. The settlement with Barr does not end all disputes related to generic XOPENEX Inhalation Solution products, as litigation against Dey, L.P. remains pending. In compliance with U.S. law, the Settlement and License Agreement will be submitted to the U.S. Federal Trade Commission and Department of Justice and are subject to review.
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 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.
Forward-Looking Statement
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the timing of introduction of generic versions of XOPENEX Inhalation Solution and Sepracor leveraging opportunities with respect to each of its product franchises and advancing its research and development candidates. 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 with respect to products under development; the timing and success of submission, acceptance, and approval of regulatory filings; the scope of Sepracor’s trademarks, patents and the patents of others and the success of challenges by others of Sepracor’s patents; the clinical benefits and commercial success of Sepracor’s products; Sepracor’s ability to successfully implement its recently announced corporate restructuring and workforce reduction plan and reduce expenses; the ability of Sepracor to attract and retain qualified personnel; the ability of Sepracor to successfully collaborate with third parties; the performance of Sepracor’s licensees and other collaboration partners; and certain other factors that may affect future operating results that are detailed in Sepracor’s annual report on Form 10-K for the year ended December 31, 2008 filed with the 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.
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.
Contact:
Sepracor Inc. Jonaé R. Barnes, 508-481-6700 Sr. Vice President, Investor Relations and Corporate Communications
