Nycomed, Forest Lung Drug Daxas Gets EU Backing

European regulators Friday gave privately held Swiss pharmaceutical company Nycomed SCA and U.S.-based Forest Laboratories Inc. (FRX) welcome news by backing their key lung drug Daxas after it was rebuffed earlier this month in the U.S.

The European Medicines Agency said it was recommending approval for Daxas as maintenance treatment for severe chronic obstructive pulmonary disease, or COPD, associated with chronic bronchitis in adult patients as an add-on to bronchodilator treatment.

On April 7, a Food and Drug Administration panel voted not to approve Daxas to treat certain patients with COPD, triggering a sell-off in Forest Laboratories's shares. The decision came after two previous positive votes on Daxas, also known by its generic name, roflumilast, on safety and effectiveness. The FDA usually follows the advice of its panels but isn't required to do so.

Zurich-based Nycomed, which plans an IPO in the near future, welcomed the European decision.

Anders Ullman, executive vice president for research and development at Nycomed, said in a statement: "Nycomed is excited about the positive opinion ... Daxas is the first in a new class of oral agents to treat this life-threatening condition, offering clinicians and patients a much-needed new treatment option alongside existing inhaled therapies."

-By Sten Stovall, Dow Jones Newswires; +44 207 842 9292; sten.stovall@dowjones.com

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