- Ciclesonide is the active ingredient in ALVESCO HFA Inhalation
Aerosol for asthma and OMNARIS AQ Nasal Spray for allergic
- ALVESCO HFA and OMNARIS AQ are FDA-approved and scheduled for
launch in 2008
- Agreement expands Sepracor's pipeline by inclusion of OMNARIS
HFA, ALVESCO inhalation solution and ALVESCO in combination
with a long-acting beta-agonist
- The U.S. market for inhaled corticosteroids is estimated at
approximately $1.2 billion(1)
- The U.S. market for nasal corticosteroids is estimated at
approximately $2.4 billion(2)
MARLBOROUGH, Mass. & ZURICH, Switzerland--(BUSINESS WIRE)--Jan.
28, 2008--Sepracor Inc. (Nasdaq: SEPR) and Nycomed today announced an
exclusive development, marketing and commercialization agreement for
ciclesonide in the United States. Ciclesonide, Nycomed's proprietary
corticosteroid, has a unique activation mechanism and is the active
ingredient in ALVESCO HFA (hydrofluoroalkane) Inhalation Aerosol MDI
(metered-dose inhaler) for the treatment of asthma and in OMNARIS AQ
Nasal Spray for the treatment of allergic rhinitis. The broad
ciclesonide franchise complements Sepracor's respiratory portfolio and
further leverages the company's commercial infrastructure with both
OMNARIS AQ and ALVESCO HFA projected to be launched in 2008.
Sepracor expects to launch OMNARIS AQ during the 2008 spring
allergy season and ALVESCO HFA in the second half of 2008. Sepracor
has obtained development rights to several line extensions, which have
the potential to broaden the ciclesonide and current Sepracor
respiratory franchises. These programs include OMNARIS HFA MDI, a
Phase II candidate; ALVESCO inhalation solution, a preclinical
candidate; and ALVESCO in combination with a long-acting beta-agonist,
an early clinical candidate. Nycomed will receive an upfront payment
of $150 million and may become entitled to receive subsequent payments
of up to $280 million over the life of the agreement upon
accomplishment of various development and sales milestones. Nycomed
will also receive compensation for providing finished product, and
royalties on sales of ciclesonide products.
"We are delighted with this agreement, as OMNARIS AQ and ALVESCO
HFA represent two new and exciting products for our 1,600-person sales
force to launch in 2008. We are also pleased with the additional
development assets that form part of this ciclesonide franchise," said
Adrian Adams, President and Chief Executive Officer of Sepracor. "The
ciclesonide franchise adds further strength to our growing pipeline
and is commercially synergistic with our XOPENEX(R) and BROVANA(R)
franchises. I am particularly pleased that our core strategy of fully
leveraging our existing products, growing our research and development
pipeline and successfully delivering value-enhancing business
development successes is being implemented as planned."
Nycomed retains all rights to ciclesonide outside the United
States and has partnered the product with Teijin Pharmaceuticals in
Japan where ALVESCO HFA was launched in June 2007. Nycomed has
retained rights outside the U.S. to certain line extensions and
additional products developed by Sepracor under this agreement.
"We were looking for a strategic partner both able to
commercialise the products and further develop them. With Sepracor we
have found that ideal partner," said Hakan Bjorklund, Nycomed's CEO.
"This agreement clearly leverages the potential of ciclesonide that we
believe to be one of the most innovative corticosteroids available to
patients," he added.
ALVESCO HFA and OMNARIS AQ both contain the active ingredient
ciclesonide, a unique corticosteroid that is activated into
des-ciclesonide after administration, which has potent
anti-inflammatory activity and a high affinity for glucocorticoid
receptors. Ciclesonide and des-ciclesonide have negligible
bioavailability due to low gastrointestinal absorption and first pass
metabolism. In large, well-controlled clinical trials, once-daily
dosing with OMNARIS AQ demonstrated significant improvements in the
Total Nasal Symptom Scores compared to placebo, with this effect
maintained for up to one year in a long-term, daily administration
study with no evidence of tolerance (loss of effect over time).
ALVESCO HFA, in large, well-controlled clinical trials demonstrated
significant improvements in asthma control measured as morning
pre-dose FEV1, which is a test of lung function, morning peak
expiratory flow and reduced need for rescue albuterol compared to
placebo. Additionally, patients with more severe asthma previously
maintained on oral corticosteroids were able to significantly reduce
their oral prednisone use.
About Ciclesonide, ALVESCO HFA and OMNARIS AQ
Ciclesonide is Nycomed's proprietary corticosteroid with a unique
activation mechanism. It is a prodrug that is activated by
intracellular esterases following oral or nasal inhalation.
ALVESCO (ciclesonide) HFA Inhalation Aerosol is a next generation
inhaled corticosteroid that reduces inflammatory processes and is
indicated for use in patients with asthma. ALVESCO HFA has been
approved in 45 countries including the U.S. and introduced in 30, with
more launches expected in 2008. ALVESCO HFA is based on the active
ingredient, ciclesonide. ALVESCO HFA has wide inhibitory activities
against multiple inflammatory cell types and chemicals involved in the
Inhaled corticosteroids are well accepted as first-line asthma and
allergic rhinitis therapy. They inhibit the activity of
pro-inflammatory cells and promote the endogenous production of
anti-inflammatory substances. With regular use of these
corticosteroids, the inflammation in the lungs and airways that
underlies asthma is attenuated.
In clinical trials, ALVESCO HFA was generally well tolerated. The
most common adverse reactions (>3%) were headache, nasopharyngitis,
sinusitis, pharyngolarynegeal pain, upper respiratory infection,
arthralgia, nasal congestion, pain in the extremities and back pain.
Treatment with orally inhaled corticosteroids may lead to signs or
symptoms of hypercorticism, suppression of
hypothalamic-pituitary-adrenal (HPA) function and/or suppression of
growth in children. Glaucoma, increased intraocular pressure and
cataracts have been reported following the administration of inhaled
ALVESCO (ciclesonide) HFA Inhalation Aerosol is an orally inhaled
corticosteroid indicated for the maintenance treatment of asthma as
prophylactic therapy in patients 12 years of age and older. ALVESCO is
not indicated for the relief of acute bronchospasm.
OMNARIS (ciclesonide) AQ Nasal Spray is the intranasal formulation
of ciclesonide 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. Intranasal corticosteroids are well
accepted as first-line therapy for the treatment of allergic rhinitis,
and they work by reducing inflammation - the major underlying cause of
the clinical symptoms. Ciclesonide nasal spray was shown to have a
favorable safety profile. The most frequently reported adverse events
seen with ciclesonide nasal spray were headache, epistaxis,
nasopharyngitis, ear pain, and pharyngolaryngeal pain. The replacement
of a systemic corticosteroid with a topical corticosteroid can be
accompanied by signs of adrenal insufficiency. Intranasal
corticosteroids may cause a reduction in growth velocity when
administered to pediatric patients.
Allergic rhinitis is a chronic inflammatory disease of the nasal
mucosa causing sneezing, itching, nasal congestion and discharge.
Seasonal allergic rhinitis is caused by substances that trigger
allergies and is sometimes referred to as "hay fever." Perennial
allergic rhinitis is a chronic condition caused by triggers such as
pet dander and dust. The result of poorly controlled allergies can
result in impairments in day-to-day activities as well as a reduction
in a patient's quality of life. According to the American Academy of
Allergy, Asthma, and Immunology, more than 40 million Americans are
currently estimated to suffer with allergic diseases, and allergies
are the sixth leading cause of chronic disease in the United States.
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 and
BROVANA(R) brand arformoterol tartrate Inhalation Solution. Sepracor's
corporate headquarters are located in Marlborough, Massachusetts.
Nycomed is a pharmaceutical company that provides medicines for
hospitals, specialists and general practitioners, as well as
over-the-counter medicines in selected markets.
The company is active within a range of therapeutic areas,
including cardiology, gastroenterology, osteoporosis, respiratory,
pain and tissue management. New products are sourced both from the
company's own research and from external partners. Operating
throughout Europe and in fast-growing markets such as Latin America,
Russia/CIS and the Asia-Pacific region, Nycomed has a presence in
about 50 markets worldwide.
Privately owned, the combined group had annual sales of
approximately EUR 3.4 billion and an EBITDA of EUR 933.4 million (2006
For more information visit www.nycomed.com.
Sepracor Forward-Looking Statement
This news release contains forward-looking statements that involve
risks and uncertainties, including statements with respect to the
development, commercialization and distribution of products containing
ciclesonide; the expected launch of OMNARIS AQ during the 2008 spring
allergy season and plans to launch ALVESCO HFA in the second half of
2008; the supply of finished product by Nycomed; Sepracor's future
pipeline; and future payments by Sepracor to Nycomed. Among the
factors that could cause actual results to differ materially from
those indicated by such forward-looking statements are: the clinical
benefits, efficacy and safety of products containing ciclesonide; the
timing and success of the development of products containing
ciclesonide; unexpected delays in commercial introduction and the
commercial success of products containing ciclesonide; Nycomed's
ability to supply or obtain from third parties Sepracor's requirements
for products or components covered by the agreement with Nycomed; the
success of Sepracor's alliance with Nycomed; the scope of Nycomed's
and/or Sepracor's patents and the patents of others; the ability of
Sepracor and Nycomed to attract and retain qualified personnel; and
certain other factors that may affect future operating results that
are detailed in Sepracor's quarterly report on Form 10-Q for the
quarter ended September 30, 2007 filed with the Securities and
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.
1. IMS Health, moving average total for inhaled corticosteroids as
of November 2007.
2. IMS Health, moving average total for nasal corticosteroids as
of November 2007.
Omnaris is a trademark and Alvesco is a registered trademark of
Nycomed GmbH. Lunesta, Xopenex, Xopenex HFA and Brovana are registered
trademarks of Sepracor Inc.
For a copy of this release or any recent release, visit Sepracor's
web site at www.sepracor.com.
CONTACT: Sepracor Inc.
David P. Southwell, 508-481-6700
Chief Financial Officer
Jonae R. Barnes, 508-481-6700
Sr. Vice President
SOURCE: Sepracor Inc.