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Sepracor Inc. today announced it has signed a technology license and development agreement with Arrow International Limited (Arrow), a European company, for know-how and intellectual property rights related to stable sterile steroid suspension formulations as well as other applicable nebule technology for the use in developing ciclesonide, a corticosteroid, in an inhalation solution.
MARLBOROUGH, MA, USA | May 1, 2008 | Sepracor Inc. (Nasdaq: SEPR) today announced it has signed a technology license and development agreement with Arrow International Limited (Arrow), a European company, for know-how and intellectual property rights related to stable sterile steroid suspension formulations as well as other applicable nebule technology for the use in developing ciclesonide, a corticosteroid, in an inhalation solution. The agreement facilitates enhanced development of Sepracor's ciclesonide stand-alone product for the treatment of asthma as well as a planned ciclesonide/ BROVANA(R) brand arformoterol tartrate Inhalation Solution combination product for the treatment of COPD, and includes Arrow's "U-Bend" packaging technology, which allows increased accuracy in dosing through a novel U-Bend ampule design.
* Agreement provides Sepracor with a global license covering development of stable suspension formulations and nebule technology in ciclesonide inhalation solution for asthma and chronic obstructive pulmonary disease (COPD)
* Agreement also supports a franchise management strategy for a BROVANA(R) brand arformoterol tartrate Inhalation Solution combination with ciclesonide
* Both ciclesonide-based projects are intended to expand Sepracor's inhalation solution product offerings
"The identification of technology to enable the successful development of a stable sterile ciclesonide suspension for nebulization has been a priority for Sepracor for our newly attained ciclesonide franchise since only a limited number of approaches can be used," said Mark H.N. Corrigan, M.D., Executive Vice President, Research and Development at Sepracor. "Arrow and its affiliates have significant experience and success in the development of inhalation solution products, particularly with corticosteroids, and we are excited to have in-licensed this technology that should assist us in moving forward two important clinical development programs in our respiratory portfolio, which could provide a significant number of patients with COPD with greater convenience in treating their disease."
Arrow is entitled to receive $250,000 upon execution of the agreement and future payments of up to $22.5 million in support of the ciclesonide stand-alone product. In addition, Arrow is also entitled to receive $250,000 upon execution of the agreement and future milestones of up to $25.0 million in support of Sepracor's planned ciclesonide/BROVANA combination product. Arrow will also receive a low single-digit royalty on Sepracor's sales of these products.
Under this agreement, 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 will oversee the development program and is responsible for all commercial activities associated with the product in the U.S. Arrow will be responsible for formulation development.
Ciclesonide is a corticosteroid with a novel activation mechanism. It is a prodrug that is site-activated by intracellular esterases following oral or nasal inhalation.
Sepracor recently launched OMNARIS(TM) brand ciclesonide Nasal Spray, which is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older, and with perennial allergic rhinitis in adults and adolescents 12 years of age and older. Sepracor anticipates launching ALVESCO brand ciclesonide Inhalation Aerosol in a metered-dose inhaler for the treatment of asthma during the second half of 2008.
BROVANA is a long-term, twice-daily (morning and evening), maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema. BROVANA is for use by nebulization only.
About asthma and COPD
Asthma is a chronic lung disorder characterized by reversible airway obstruction and a pathologic finding of airway inflammation. According to the 2002 National Health Interview Survey conducted by the Centers for Disease Control and Prevention, nearly 31 million Americans have been diagnosed with asthma in their lifetime. It is the most common childhood illness and affects nearly 9 million children in the U.S. under the age of 18.
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.
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(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 and OMNARIS(TM) brand ciclesonide Nasal Spray. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
SOURCE: Sepracor Inc. |
