Nycomed and Orion : to collaborate on Easyhaler® for asthma and COPD

4 August 2011 - Orion Corporation (Nasdaq OMX Helsinki: ORNAV and ORNBV) announced that it has entered into a collaboration agreement with Nycomed for the co-marketing of Easyhaler® combination products for the treatment of asthma and COPD in the major European countries and an exclusive license and distribution arrangement for the Middle East and North Africa region (MENA). Both companies will commercialise Easyhaler combination products under their own brands accompanied by the Easyhaler umbrella brand.

The agreement covers Orion’s new Easyhaler combination products for treatment of asthma and COPD (chronic obstructive pulmonary disease). Orion is developing a budesonide-formoterol formulation that combines budesonide as an anti-inflammatory agent and formoterol as a long-acting bronchodilator. In addition, Orion has another Easyhaler® research programme in progress to develop a fluticasone-salmeterol formulation. In this formulation fluticasone acts as an anti-inflammatory agent and salmeterol acts as a long-acting bronchodilator. Both these combination products are included in the co-marketing agreement.

Respiratory is a key strategic area for Nycomed, including the COPD treatment Daxas® (roflumilast), Alvesco® (ciclesonide) for asthma, and Omnaris® for allergic rhinitis. The collaboration with Nycomed reinforces Orion’s presence throughout Europe and is in line with Orion's strategy to strengthen its marketing position in Europe and the sales coverage through partnerships. The co-marketing area - in which both companies present their own product brands under the Easyhaler umbrella brand - covers the major European countries including Austria, the Benelux countries, France, Germany, Greece, Italy, Poland, Portugal, Spain and Switzerland. Orion will retain exclusive marketing rights for the Nordic countries, U.K. and Eastern Europe where the company is currently promoting single molecule Easyhaler products. Orion will exclusively manufacture the Easyhaler combination products covered by the agreement... Orion's Press Release - Nycomed's Press Release -

Nycomed’s novel anti-inflammatory therapy Daxas® (roflumilast) : marketing authorisation in the European Union for patients with COPD

06.07.2010 :

• Anti-inflammatory treatment aimed at patients with severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis
• First new class of treatment for COPD in more than a decade
• Improves lung function and reduces exacerbations, when added to bronchodilator treatment

Nycomed announced that the European Commission has granted marketing authorisation for Daxas® (roflumilast) in the European Union. Daxas® is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that has been developed by Nycomed for the treatment of COPD, a progressive, life-threatening lung disease.

Daxas® is indicated for maintenance treatment of severe COPD (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as an add-on to bronchodilator treatment. Daxas, an oral tablet taken once a day, is the first drug in a new class and is expected to be launched soon in the first European countries, starting with Germany and the UK... Nycomed's Press Release -

Micromet and Nycomed : Formal Preclinical Safety Studies for Antibody MT203 for Inflammatory and Autoimmune Diseases

June 24, 2008 - Micromet, Inc. (Nasdaq: MITI) and Nycomed announced the initiation of formal preclinical safety studies for the anti-GM-CSF human antibody MT203. Micromet received $775,000 (n 500,000) from Nycomed for the achievement of this milestone.
Under a 2007 agreement between the two companies, Micromet and Nycomed develop MT203, a fully human anti-GM-CSF antibody that may be useful for the treatment of various inflammatory and autoimmune diseases.

Preclinical studies support MT203's development for the treatment of rheumatoid arthritis and several other indications, including multiple sclerosis, psoriasis, asthma and chronic obstructive pulmonary disease... Micromet's Press Release -

Sepracor and Nycomed : exclusive development, marketing and commercialization agreement for ciclesonide in the U.S.

Jan. 28, 2008--Sepracor Inc. (Nasdaq: SEPR) and Nycomed announced an exclusive development, marketing and commercialization agreement for ciclesonide in the United States. Ciclesonide, Nycomed's proprietary corticosteroid, has a unique activation mechanism and is the active ingredient in ALVESCO HFA (hydrofluoroalkane) Inhalation Aerosol MDI (metered-dose inhaler) for the treatment of asthma and in OMNARIS AQ Nasal Spray for the treatment of allergic rhinitis. The broad ciclesonide franchise complements Sepracor's respiratory portfolio and further leverages the company's commercial infrastructure with both OMNARIS AQ and ALVESCO HFA projected to be launched in 2008... Sepracor's Press Release - Nycomed's Press Release-

Nycomed, ALVESCO , FDA approval for the U.S. market

15.01.2008 - Nycomed announced today that the Food and Drug Administration (FDA) approved ALVESCO (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 is an inhaled corticosteroid with novel release and distribution properties...
...ALVESCO 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 has wide inhibitory activities against multiple inflammatory cell types and chemicals involved in the asthmatic response... Nycomed's Press Release-