ALVESCO(R) (ciclesonide) Inhalation Aerosol Approved by FDA for the
Maintenance and Prophylactic Treatment of Asthma in Patients 12 years of
Age and Older
ALVESCO(R) Will be Commercialised by U.S. Partner
ZURICH, Switzerland, Jan. 16 /CNW/ - Nycomed announced today that the
Food and Drug Administration (FDA) approved ALVESCO(R) (ciclesonide)
Inhalation Aerosol in the United States for the maintenance treatment of
asthma and as prophylactic therapy in adult and adolescent patients aged 12
years and older. ALVESCO(R) is an inhaled corticosteroid with novel release
and distribution properties. Commercialisation and marketing of ALVESCO(R)
will be achieved through a U.S. commercial partner.
The decision of the FDA allows the product to be sold in the largest
pharmaceutical market in the world, where it is patent protected until 2017.
Nycomed is in active negotiations with possible marketing partners for the
commercialisation of ALVESCO(R) in the United States. The outlicensing
strategy in the U.S. is consistent with Nycomed's direction to seek marketing
and commercialisation partnerships for the Nycomed's assets in the U.S.
"The approval of ALVESCO(R) provides a new and effective treatment option
to help patients control their asthma and improve their quality of life, and
will be an important treatment option for physicians," said Myron Zitt, MD,
chief of allergy and immunology at the Queens Long Island Medical Group in
Babylon, N.Y., and clinical associate professor of medicine at the State
University of New York, Stony Brook, School of Medicine.
"We are very much looking forward to serving patients in the United
States with this innovative drug and build upon the experience we already have
gained with ALVESCO(R). This approval certainly adds to the respiratory area,
which is a key segment for Nycomed to grow", comments Dick Soderberg,
Executive Vice President of International Marketing.
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
ALVESCO(R) is based on the active ingredient ciclesonide which is
Nycomed's patented corticosteroid with a novel principle of action.
Ciclesonide is a prodrug that is activated by intracellular esterases
following oral inhalation. ALVESCO(R) has wide inhibitory activities against
multiple inflammatory cell types and chemicals involved in the asthmatic
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.
Asthma is a chronic lung disease caused by airway inflammation and
results in airway constriction in response to certain stimuli. It is
characterized by a variety of symptoms including wheezing, coughing and a
tightening of the airways, which causes shortness of breath and can be
Approximately 22 million Americans have asthma. Annually, the disease is
responsible for nearly 2 million emergency room visits and accounts for an
estimated $11.5 billion in health care costs(ii). Every day in America 40,000
people miss school or work because of asthma; 30,000 people have an asthma
attack; 5,000 people visit the emergency room; 1,000 people are admitted to
the hospital; and 11 people die due to their asthma condition(iii).
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
(i) National Heart Lung Blood Institute (NHLBI)
(ii) American Academy of Allergy, Asthma and Immunology, Asthma
(iii) American Academy of Allergy, Asthma and Immunology, Asthma
For further information:
For further information: U.S. media: Renee Martin, Ashley Altieri,
Spectrum Science Communications, Phone: (202) 955-6222, Washington, DC; Media:
Tobias Cottmann, Director External Communications, Phone: +41-44-555-15-10;
Investors: Christian B. Seidelin, Vice President Controlling, Treasury and
Insurance, Phone: +41-44-555-11-04