Nycomed and Merck reach deal for Daxas

Nycomed has announced it has reached an agreement with Merck regarding the 'co-promotion' of investigational lung disease drug, Daxas (roflumilast), in Canada and certain European countries.

The two companies have also signed an exclusive distribution agreement for the commercialisation of Daxas in the UK.

The deal will see Nycomed receive an undisclosed upfront fee from Merck, with milestone payments based on regulatory and commercial achievements also available.

Daxas is a once-daily drug for patients with chronic obstructive pulmonary disease (COPD) – a collective term for a group of lung diseases that make breathing difficult. It is currently awaiting approval from certain national regulatory bodies, though Nycomed recently announced that the treatment had received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the approval of Daxas in the EU.

If approved, Daxas would be the first oral anti-inflammatory treatment available for COPD, offering an alternative to inhaled bronchodilators and inhaled corticosteroids.

Under the terms of the agreement, Merck and Nycomed will co-promote the drug in France, Germany, Italy, Portugal, Spain and Canada once regulatory approval has been granted. Nycomed will manufacture and distribute the product in these countries.

In the UK, Merck will have exclusive commercial rights for the drug, with Nycomed supplying the finished product and retaining a co-promotion option.

"This agreement with Nycomed for a late-stage PDE4 inhibitor [a treatment to target cells and mediators in the body believed to be important in the COPD disease process] candidate represents a strong strategic fit for Merck," said Kevin Ali, senior vice president and general manager Bone, Respiratory, Immunology and Dermatology franchise at Merck.

"This builds upon Merck's leadership in the asthma and allergy marketplace and positions the company to leverage our well-trained sales force to target the rapidly growing unmet medical need of COPD."