01.05.2008 11:00:00
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Sepracor and Arrow Sign Global License and Development Agreement Covering Technology to Enhance Ciclesonide and BROVANA(R) Franchises
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®
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.
"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™
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®
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.
Forward-Looking Statement
This news release contains forward-looking statements that involve risks
and uncertainties, including statements with respect to development of a
nebulized ciclesonide stand-alone product for the treatment of asthma
and a nebulized ciclesonide/BROVANA combination product for the
treatment of COPD; the safety, efficacy and potential benefits of any
ciclesonide products developed by Sepracor; the expectation that the
technology Sepracor is licensing from Arrow will assist the company in
moving forward two important clinical development programs; future
payments from Sepracor to Arrow; and the estimated increase in the
prevalence of COPD in future years. 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 ciclesonide products; the
timing and success of submission, acceptance and approval of regulatory
filings; the clinical benefits and commercial success of Sepracor’s
products, including any ciclesonide products it may develop; the scope
and validity of the intellectual property Arrow 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 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.
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