Forest Laboratories and Nycomed have suffered a setback with the news that advisors to the US Food and Drug Administration voted against recommending approval of Daxas as a treatment for chronic obstructive pulmonary disease.

The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 10-5 against approval of Daxas (roflumilast), an oral once-daily phosphodiesterase 4 enzyme inhibitor. Forest licensed the drug from Nycomed in August last year in a deal that could be worth around $600 million to the privately-owned Swiss firm.

The final vote came as a bit of a surprise given that earlier the panel voted 9 to 6 that Daxas is effective as a maintenance treatment for COPD, despite FDA staff documents having described the drug's benefit as modest. The committee also voted 9-6 that the drug appears to be safe.

Nevertheless, the panellists claimed that Daxas data shows that the drug produced only a modest improvement in lung function in trials and expressed concerns about side effects.Specifically they were concerned about the three suicides and two suicide attempts in roflumilast patients, compared with none of either in patients on placebo. Also 218 cancer/tumour events were reported in 208 patients, 60% of whom were in the Daxas group.

Forest pointed out that there was no evidence Daxas caused the suicides or raised the risk of cancer and noted that other side effects such as diarrhoea were manageable. The company’s president Lawrence Olanoff told reporters that “having the final vote go opposite from the first two votes was a bit of a disappointment…but at the end of the day, we didn't hear anything that couldn't be negotiated”.

The FDA is due to make its decision by the middle of May and analysts believe Forest is still in with a shout, seeing as how the company recently modified the drug's proposed use from broad treatment of COPD to reducing exacerbations. The panel voted on the former.

Forest is hoping that Daxas will be a big-seller, especially as its blockbuster antidepressant Lexapro (escitalopram) will go off-patent in 2012.

As for Nycomed, it started the week well when the FDA approved TachoSil (ibrinogen/thrombin), a surgical patch partnered with Baxter International, as an adjunct to haemostasis in cardiovascular surgery.