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Spanish drug maker Laboratorios Almirall SA (ALM.MC) has started additional studies on a drug for chronic obstructive pulmonary disease, or COPD, following a request for more information from U.S. and European Union health authorities.
In a regulatory filing, Almirall said the company expects to file a new-drug application for the product in late 2011 or early 2012 in the U.S. and in Europe.
Initially, Almirall and its U.S. partner Forest Laboratories Inc. (FRX) had planned to apply late this year or early 2010 for approval for their COPD product, aclidium bromide.
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.
Almirall said it would give further details on the program later this year.
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 Christopher Bjork, Dow Jones Newswires, +34 91 395 81 23, email@example.com