ZURICH, Jan. 28 /CNW/ - Nycomed has granted Sepracor, Inc. (NASDAQ: SEPR)
the exclusive development, marketing and commercialisation rights for
Ciclesonide in the United States. Ciclesonide is Nycomed's patented
corticosteroid with a novel principle of action. It is the active ingredient
in the ALVESCO(R) Inhalation Aerosol for the treatment of asthma and in the
Omnaris(TM) Nasal Spray for the treatment of allergic rhinitis. The agreement
complements Sepracor's respiratory portfolio and is a boost to Nycomed's
partnering approach for the United States.
- Sepracor acquires exclusive development, marketing and
commercialisation rights to the Ciclesonide franchise in the United
- Ciclesonide is the active ingredient in the ALVESCO(R) Inhalation
Aerosol for asthma and the Omnaris(TM) Nasal Spray for allergic
- ALVESCO(R) and Omnaris(TM) are FDA-approved and are on track to be
launched in 2008
- Agreement is in alignment with Nycomed's strategy to cooperate with
the best partners for its key brands in the United States
- Partnership between Nycomed and Sepracor provides a good strategic
fit for both companies
Sepracor will gain exclusive rights for Ciclesonide in the United States.
Sepracor expects to launch Omnaris(TM) in the 2008 spring allergy season and
ALVESCO(R) in the second half of 2008. Sepracor will not only commercialise
the approved products ALVESCO(R) and Omnaris(TM), but plans to develop line
extensions and additional products broadening the Ciclesonide and current
Sepracor respiratory franchise. Nycomed will receive an upfront payment of
$150 million and subsequent payments upon accomplishment of various
development and sales milestones, which could include up to an additional
$280 million over the life of the agreement if all milestones are met. Nycomed
will also receive compensation for providing finished product and royalties on
sales of Ciclesonide products.
Nycomed retains all rights to Ciclesonide outside the United States and
has partnered the product with Teijin Pharmaceuticals in Japan where
ALVESCO(R) was launched in June 2007. Nycomed also has rights for the
territories outside the United States to certain line extensions and
additional products developed by Sepracor under the agreement.
Sepracor develops and markets a range of products in the respiratory
field. ALVESCO(R) and Omnaris(TM) complement Sepracor's respiratory portfolio
and expand its product pipeline with Ciclesonide line extension programs.
These programs include Omnaris(TM) HFA, a hydrofluoroalkane (HFA) metered-dose
inhaler Phase II candidate; ALVESCO(R) inhalation solution, a preclinical
candidate; and ALVESCO(R) in combination with a long-acting beta-agonist, an
early clinical candidate.
"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.
"We are delighted with this agreement, as OMNARIS AQ and ALVESCO HFA
represent two new and exciting products for our 1600 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."
About Ciclesonide, ALVESCO(R) and Omnaris(TM)
Ciclesonide is Nycomed's patented corticosteroid with a novel principle
of action. It is a prodrug that is activated by intracellular esterases
following oral or nasal inhalation.
ALVESCO(R) (Ciclesonide) Inhalation Aerosol is a new generation of
inhaled corticosteroid that reduces inflammatory processes and is indicated
for the use in patients with asthma. ALVESCO(R) has been approved in 45
countries including the U.S. and introduced in 30, with more launches expected
in 2008. ALVESCO(R) is based on the active ingredient Ciclesonide. ALVESCO(R)
has wide inhibitory activities against multiple inflammatory cell types and
chemicals involved in the asthmatic response.
Inhaled corticosteroids (ICS) are regarded today as the gold standard in
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 the asthma is attenuated.
In clinical trials, ALVESCO(R) was generally well tolerated. The most
common adverse reactions (greater than 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 corticosteroids.
ALVESCO(R) (Ciclesonide) Inhalation Aerosol is an orally inhaled
corticosteroid indicated for the maintenance treatment of asthma as
prophylactic therapy in adult patients 12 years of age and older. ALVESCO(R)
is NOT indicated for the relief of acute bronchospasm.
Omnaris(TM) (Ciclesonide) 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 considered to be the gold standard 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.
The U.S. market for inhaled corticosteroids is estimated at approximately
$1.2 billion (IMS Health, moving average total for inhaled corticosteroids as
of November 2007).
The U.S. market for nasal corticosteroids is estimated at approximately
$2.4 billion (IMS Health, moving average total for nasal corticosteroids as of
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 brand levalbuterol HCl
Inhalation Solution, XOPENEX HFA brand levalbuterol tartrate Inhalation
Aerosol and BROVANA brand arformoterol tartrate Inhalation Solution.
Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
For more information visit http://www.sepracor.com
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 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 results).
For more information visit http://www.nycomed.com
For further information:
For further information: Media: Tobias Cottmann, Director External
Communications, Phone +41-44-55-515-10; Investors: Christian B. Seidelin, Vice
President Controlling, Treasury and Insurance, Phone +41-44-55-51-104