NEW YORK Nycomed and Forest Labs announced that they have entered into an exclusive development, manufacturing and commercialization agreement in the United States for Daxas(roflumilast), a once-daily oral treatment for patients suffering from symptomatic chronic obstructive pulmonary disease.
Nycomed will retain marketing rights to Daxas in Europe and the rest of the world.
Under the terms of the agreement, Forest Labs 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 U.S. net sales typical for a product, which is in registration. Forest will assume responsibility for the U.S. regulatory approval and commercialization 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 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 Food and Drug Administration in July.