DOW JONES NEWSWIRES
Forest Laboratories Inc. (FRX) and Laboratorios Almirall SA
(ALM.MC) announced the U.S. Food and Drug Administration will
require additional studies of the Spanish company's chronic
obstructive pulmonary disease treatment.
As a result the companies don't know when they will file a
new-drug application for the product. One had been anticipated late
this year or early 2010.
COPD is a progressive, smoking-related lung disorder that is
often fatal. Forest Labs and Almirall in 2006 reached a deal to
jointly develop, market and distribute Almirall's treatment in the
U.S.
Forest Labs disclosed study results in 2007 that showed single
doses of inhaled aclidinium bromide produced a significant
bronchodilatory response in 17 patients with COPD.
The companies said Friday the additional studies will include
higher and/or more frequent dosing than previously tested.
Almirall shares were recently down 5.3% to EUR6.03 in Madrid.
Forest Labs closed Thursday at $19.25 and was inactive
premarket.
-By Kevin Kingsbury, Dow Jones Newswires; 201-938-2136;
kevin.kingsbury@dowjones.com