Roflumilast review process in Europe and U.S. is in progress.

Nycomed and Forest Laboratories report on four published Phase III trials showing that the once-daily oral COPD therapy called roflumilast provided significant improvements in lung function. It also reduced lung attacks in patients already taking bronchodilator therapies.

Nycomed submitted roflumilast for review to European regulatory authorities in May and to FDA in July. On August 10 Forest Labs negotiated a $100 million agreement for exclusive U.S. commercialization rights to the drug. The deal was sealed just 10 days before Forest announced that oglemilast, Glenmark Pharmaceuticals’ oral oral phosodiesterase 4 (PDE4) inhibitor to which it also has U.S. rights, had failed in Phase II COPD trials.

Nycomed’s 12-month studies found that treatment with roflumilast, also an oral PDE4 inhibitor, reduced the incidence of moderate-to-severe exacerbations by 17% per patient per year, irrespective of concomitant treatment with long-acting beta-2 agonists. All four trials showed roflumilast therapy led to notable benefits across a range of prespecified endpoints including significant improvements in pre- and postbronchodilator FEV1.  The two six-month and two 12-month trials will be published in the August 29 issue of The Lancet.

Peter Calverley, M.D., professor of respiratory of medicine at the University of Liverpool and lead author of the 12-month studies, points out roflumilast doesn’t work in the same way as bronchodilators and acts on the underlying disease rather than just on the symptoms of COPD.

“Roflumilast has a novel mode of action and has the potential to become the first of a new class of drugs and potentially the only completely new treatment option for COPD in the next several years,” adds Leonardo Fabbri, M.D., professor of respiratory medicine at the University of Modena and Reggio Emilia (Italy) and lead author of the six-month studies. “The lung function improvements on top of current broncholdilation clearly indicate that roflumilast improves lung function over and above what can be achieved with other COPD treatments alone.”

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