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ALVESCO(R) Gains FDA Approval for the U.S. Market
Date:1/16/2008

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, January 16 /PRNewswire/ -- 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. market.

"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 Int
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SOURCE Nycomed International Management GmbH
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