Deal follows CHMP’s recommendation to approve Daxas.
Merck & Co. and Nycomed inked a co-promotion agreement for the latter’s Daxas®, an oral therapy for chronic obstructive pulmonary disease (COPD), in France, Germany, Italy, Spain, Portugal, and Canada. The firms also signed an exclusive distribution agreement for commercialization of the drug in the U.K.
The announcement comes less than a week after the EMEA’s Committee for Medicinal Products for Human Use (CHMP) recommended approving Daxas in the EU. The once-daily selective phosphodiesterase 4 (PDE4) enzyme inhibitor is also under review in Canada and the U.S. In August 2009, Forest Laboratories acquired exclusive commercialization rights to Daxas in the U.S. The deal included a $100 million up-front payment and calls for further regulatory and commercialization milestones and sales royalties.
Nycomed claims that if approval in the EU is finalized, Daxas will be the first oral anti-inflammatory therapy for patients with the condition. Regulatory filing for Daxas in the EU was based on data from four Phase III trials. In two pivotal trials involving a total of over 3,000 patients, Daxas resulted in statistically significant improvements in both moderate-to-severe exacerbations and prebronchodilator FEV1. The benefits of Daxas were observed independently to concomitant use of long-acting beta2-agonist (LABA). Two supporting studies showed that in comparison with placebo, treatment with Daxas resulted in statistically significant improvements in lung function when added to treatment with the long-acting bronchodilators, tiotropium, or salmeterol.