Healthcare Industry News: OMNARIS
News Release - May 1, 2008
Sepracor and Arrow Sign Global License and Development Agreement for XOPENEX(R)/Ipratropium Inhalation Solution CombinationXOPENEX(R)/ipratropium inhalation solution product is Phase III-ready with potential launch in 2011 for the treatment of chronic obstructive pulmonary disease (COPD)
XOPENEX/ipratropium inhalation solution product, together with potential follow on combination products, will broaden the XOPENEX franchise
MARLBOROUGH, Mass.--(HSMN NewsFeed)--Sepracor Inc. (Nasdaq: SEPR ) today announced that it has signed a global license and development agreement with Arrow International Limited (Arrow), a European company, for a XOPENEX brand levalbuterol/ipratropium inhalation solution product, which formulation is currently ready to enter Phase III clinical development. The agreement includes rights to intellectual property covering the development and commercialization of the product.
“This XOPENEX/ipratropium formulation should provide us with an exciting franchise management opportunity that has the potential to broaden our established XOPENEX patient base by providing increased convenience to levalbuterol patients who require the addition of an anticholinergic agent,” said Adrian Adams, President and Chief Executive Officer of Sepracor. “This license and development agreement further expands our respiratory research and development portfolio with a compound that is in late-stage clinical development and ready to move into Phase III studies. The XOPENEX/ipratropium combination, together with the recently acquired ciclesonide products, positions Sepracor as a company with one of the broadest respiratory portfolios in the U.S. market and is reflective of our overall global corporate strategy to successfully pursue aligned and value-enhancing corporate development and licensing initiatives."
Under the terms of the agreement, Arrow is entitled to receive $500,000 upon execution of the agreement and future payments of up to $70.0 million. Arrow will also receive single-digit royalties that escalate based on product sales. In addition, Sepracor will fully fund all product development activities and manage the development program, including all interactions with the U.S. Food and Drug Administration (FDA) and other regulatory bodies. Sepracor is responsible for all commercial activities associated with the product worldwide. Arrow will be responsible for the formulation development, as well as the manufacture and supply of finished dosage forms.
XOPENEX brand levalbuterol HCl Inhalation Solution is a fast-acting medicine that is used to treat the narrowing of airways (bronchospasm) caused by asthma and COPD. Levalbuterol is a short-acting beta agonist that relaxes the tightened muscles around the airway passages and relieves symptoms like coughing, sneezing, chest tightening, and shortness of breath. Ipratropium is an anticholinergic drug administered by inhalation for the treatment of obstructive lung diseases. It acts by blocking muscarinic receptors in the lung, inhibiting bronchoconstriction and mucus secretion.
The XOPENEX/Ipratropium inhalation solution product is a potential combination medicine targeted to treat patients who may benefit from short-acting beta agonists taken together with an anticholinergic agent. This formulation may have the additional benefits of reducing treatment time due to decreased volumes required compared with existing therapies.
According to the National Center for Health Statistics, COPD is the fourth leading cause of death in the U.S. and it is estimated to be the third leading cause by the year 2020. Approximately 12 million adults in the U.S. are reported to have COPD, although approximately 24 million adults have evidence of impaired lung function, which may indicate that COPD is under-diagnosed, according to the National Heart, Lung, and Blood Institute (NHLBI). COPD is a slowly progressive disease of the airways that is characterized by a gradual loss of lung function and includes chronic bronchitis, chronic obstructive bronchitis and emphysema, or combinations of these conditions.
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, BROVANA® brand arformoterol tartrate Inhalation Solution and OMNARIS™ brand ciclesonide Nasal Spray. 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 joint development of a XOPENEX/ipratropium inhalation solution product and the safety, efficacy and potential benefits of any such product; the timing and success of regulatory filings relating to XOPENEX/ipratropium inhalation solution; the potential commercialization of a XOPENEX/ipratropium inhalation solution product in 2011; future payments from Sepracor to Arrow; the potential for follow-on products, including a triple combination product; the potential broadening of the XOPENEX patient base; the estimated increase in the prevalence of COPD in future years; and the potential additional benefits of a XOPENEX/ipratropium inhalation solution product in reducing treatment time due to decreased volumes required compared with existing therapies. 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, clinical trials with respect to XOPENEX/ipratropium inhalation solution; the timing and success of submission, acceptance and approval of regulatory filings; the clinical benefits and commercial success of Sepracor’s products, including any XOPENEX/ipratropium inhalation solution product it may develop; the scope and validity of the intellectual property Arrow International Limited is licensing to Sepracor; the ability of the company to attract and retain qualified personnel; 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, 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.
Lunesta, Xopenex, Xopenex HFA and Brovana are registered trademarks of Sepracor Inc. OMNARIS is a trademark of Nycomed GmbH.
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