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Nycomed's Ciclesonide to be Commercialised in the United States by Sepracor
Date:1/28/2008

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 inh
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SOURCE Nycomed International Management AG
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