NEW YORK, Aug. 10 /PRNewswire-FirstCall/ --
- Forest Laboratories acquires exclusive commercialisation rights to Daxas((R)) in the United States in treatment of symptomatic COPD
- Nycomed to receive US$100 million upfront payment plus significant milestones and royalties
- Daxas filed for approval in US and Europe following encouraging results from four Phase III studies
- Access to Forest Laboratories' 2,700-strong US sales force completes global marketing strategy for Daxas
Nycomed and Forest Laboratories, Inc. (NYSE: FRX) today announced that they have entered into an exclusive development, manufacturing and commercialisation agreement in the United States for Daxas((R)) (roflumilast), a once-daily oral treatment for patients suffering from symptomatic Chronic Obstructive Pulmonary Disease (COPD). Nycomed will retain marketing rights to Daxas in Europe and the rest of the world.
Under the terms of the agreement, Forest Laboratories will make an upfront payment of US$100 million and additional milestone payments to Nycomed based on defined regulatory and commercialisation 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 in the United States 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 (NDA) was filed with the US Food and Drug Administration (FDA) in July and a Marketing Authorisation Application (MAA) was filed with the European Medicines Agency (EMEA) in May 2009.
Commenting on today's announcement, Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories, said, "We are pleased to have entered into this collaboration with Nycomed. Nycomed has demonstrated great dedication in bringing Daxas to its current NDA stage of development and we are looking forward to working with such a talented and committed group as we consider ways to further develop and expand the use of Daxas. Daxas represents the first in a new class of agents to treat COPD and would be the first oral agent to be approved for this debilitating disease.
