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Agreements

Date: 2011-05-05

Type of information: Commercialisation agreement

Compound: roflumilast

Company: Almirall (Spain) Nycomed (Switzerland)

Therapeutic area: Respiratory diseases

Type agreement:

commercialisation

Action mechanism:

Roflumilast is a once-daily tablet for patients with chronic obstructive pulmonary disease (COPD). It is an orally administered phosphodiesterase 4 (PDE4) enzyme inhibitor, and the first oral anti-inflammatory treatment for COPD.

Disease: chronic obstructive pulmonary disease (COPD)

Details:

Almirall and Nycomed have entered into a co-branding agreement for the commercialization of roflumilast in Spain.Under the terms of the agreement, Nycomed will receive an undisclosed upfront fee from Almirall, who will be exclusively promoting a second brand of roflumilast in Spain. Four large randomized placebo controlled trials have shown that roflumilast significantly reduces exacerbations and improves lung function when added to first-line maintenance therapy.  Roflumilast is generally well tolerated. In clinical COPD trials involving 12,000 patients, the most commonly reported adverse reactions were diarrhoea (5.9%), weight decreased (3.4%), nausea (2.9%), abdominal pain (1.9%) and headache (1.7%). The majority of these adverse reactions were mild or moderate. These adverse reactions mainly occurred within the first weeks of therapy and mostly resolved on continued treatment. Other pharmacological treatment for COPD patients includes the use of inhaled bronchodilators and inhaled corticosteroids.
Roflumilast has received marketing authorization in the EU, the United States, and a number of other countries. In Europe, Nycomed is commercializing roflumilast under the brand name Daxas®. In Spain, Daxas® was launched in February 2011.

Financial terms:

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