In a positive development yesterday, Forest Laboratories (FRX) and Nycomed announced that encouraging data from a phase III clinical trial of their lung drug was published in a prestigious medical journal. We are pleased to hear that the drug, Daxas (a phosphodiesterase, PDE 4 inhibitor), improved lung function and reduced exacerbations in chronic obstructive pulmonary disease (COPD).
The placebo-controlled trials were carried out in 4,500 patients spanning 10 countries. It evaluated the treatment in two studies, each of which covered a time span of 12 months and 6 months. Results showed that Daxas reduced COPD attacks by 17% per patient every year compared with a placebo and improved the volume of air that patients breathe out each second, a measure known as FEV1 by 48 millilitres.
Studies also showed additional benefits when Daxas was used with other treatments such as Pfizer’s (PFE) Spiriva and GlaxoSmithKline‘s (GSK) Advair. However, common side effects for PDE4 inhibitors (like diarrhea, nausea, weight loss and headaches) were noticed more in patients taking Daxas (67%) compared to placebo (62%).
Although Daxas is being developed by Nycomed, Forest Laboratories has its distribution rights in the US as per an agreement signed earlier this month. Forest paid $100 million upfront for the drug and will make another payment of $500 million after successful regulatory approvals and achievement of certain sales milestones.
The COPD market has huge potential as it is an under-diagnosed progressive lung disease which could be fatal in many cases. The World Health Organization (WHO) estimates about 80 million people suffering from moderate to severe COPD, which will emerge as the third leading cause of death by 2030. The positive outcome of the trial could fetch the drug approval from US and European Union regulatory authorities. Daxas could record robust sales on approval and would compete with GlaxoSmithKline’s Advair (with sales of £4.1 billion in 2008) in the chronic COPD market.
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