Almirall, Forest See New Drug Application For COPD By 2012
30 April 2009 - 6:01PM
Dow Jones News
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,
christopher.bjork@dowjones.com