Nycomed and Forest Labs to commercialize Nycomed's of Daxas' Daxas for COPD in USA

Switzerland-based Nycomed and US drugmaker Forest Laboratories have entered into an exclusive development, manufacturing and commercialisation agreement in the USA for Daxas (roflumilast), a once-daily oral treatment for patients suffering from symptomatic Chronic Obstructive Pulmonary Disease (COPD). Nycomed will retain marketing rights to the drug in Europe and the rest of the world.

Under the terms of the accord, Forest will make an upfront payment of $100 million and additional milestone payments to Nycomed based on defined regulatory and commercialization achievements. Nycomed will also receive royalties on US net sales typical for a product, which is in registration. Forest will assume responsibility for the US regulatory approval and commercialisation of Daxas and the companies will collaborate on future development programs. Other details of the financial terms of the agreement were not disclosed.
Daxas is an orally-administered phosphodiesterase 4 (PDE4) enzyme inhibitor targeting cells and mediators in the body believed to be important in the COPD disease process. A New Drug Application was filed with the US Food and Drug Administration in July and a Marketing Authorization Application was submitted to the European Medicines Agency (EMEA) in May.

The view of analysts is that the drug could become a blockbuster if approved, when it will compete with Boehringer Ingelheim/Pfizer's Spiriva (tiotropium), GlaxoSmithKline's Advair/Seretide (salmeterol and fluticasone) and AstraZeneca's Symbicort (budesonide/formoterol).