Alvesco product rights in the US return to Nycomed

03.05.2007Nycomed will take back the Alvesco® product rights from sanofi-aventis, the co-development and marketing partner for the US market. The collaboration with sanofi-aventis for the development and commercialization of the combination product of ciclesonide with formoterol in the US continues.
Nycomed is committed to pursue the development of Alvesco® for the US. Following its out-licensing strategy for the US, Nycomed will search for a suitable partner for commercialization of Alvesco® in the US.

We are convinced to have prepared a comprehensive and robust data package together with sanofi-aventis to receive a marketing license for Alvesco® in the US.”, said Anders Ullman, Executive Vice President and Head of Research & Development. In response to the approvable letter from the U.S. Food and Drug Administration for Alvesco® (ciclesonide) for the treatment of persistent asthma the submission of additional data will take place later this year.

Alvesco® is already approved in 44 countries and is available in more than 20 countries.Teijin Pharma Limited, one of the co-development and marketing partners, obtained manufacturing and marketing approval for Alvesco®, the first once-daily inhaled corticosteroid (ICS) agent for adult asthma in Japan, on April 18, 2007. Teijin Pharma will start promotional activities for Alvesco® shortly and will launch it soon after NHI price listing.

“With the approval in the US, Japan and in the European countries Alvesco® will become a true global product and one of the key assets in our product portfolio”, said Dick Söderberg, Executive Vice President and Head of Marketing.

About Alvesco

Alvesco® (ciclesonide) is an inhaled corticosteroid being studied for its novel release and distribution properties resulting in lung-targeted anti-inflammatory effects. Inhaled corticosteroids (ICS), considered to be one cornerstone in the asthma therapy, work by reducing inflammation – the underlying disease process – in the lungs and airways.

About Asthma

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 life-threatening.  According to the Global Initiative for Asthma (GINA), more than 300 million people worldwide suffer from asthma; the prevalence varies from 0 to 30 percent in different populations.  The prevalence of asthma is increasing by approximately 50 percent every decade and worldwide deaths from asthma total more than 180,000 annually.

About Nycomed

Nycomed provides products 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 non-audited estimated annual sales of approximately € 3.4 billion and an EBITDA of € 933.4 million (2006 results). In connection with the acquisition of ALTANA Pharma AG, effective 1 January 2007, Nycomed is relocating its group headquarters from Roskilde (Denmark) to Zurich (Switzerland).

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