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Roflumilast Phase III Data Encouraging
FRANKFURT (Reuters) 2003 Sept 10 - A phase III trial of roflumilast, an
investigational drug for COPD and asthma, has yielded positive results,
German drugmaker Altana AG said on Wednesday.
"An analysis of the data shows positive results, which also confirm
data from earlier trials," the company said in a statement.
The announcement comes just days after a U.S. Food and Drug
Administration (FDA) panel recommended that the regulator reject approval
for a similar GlaxoSmithKline drug, Ariflo.
Altana said it will present detailed results of the late-stage trial,
carried out in 1400 patients with COPD, at a conference of the European
Respiratory Society later this month in Vienna.
The firm said it plans to file an application for approval for the drug
in Europe towards the end of the year. It has said in the past that it aims
to file for U.S. approval in 2004 or 2005.
The drug is being developed worldwide, with the exception of Japan, in
partnership with Pfizer Inc. In Japan, Altana's partner is Tanabe Seiyaku
Co. Ltd.
Altana said the drug would be marketed worldwide under the brand name
Daxas.
Roflumilast belongs to a class of drugs called phosphodiestrase-4 (PDE-4)
inhibitors, which are thought to combat lung inflammation. No PDE-4
inhibitors, however, have yet been approved by the FDA and many analysts are
sceptical about the value of these drugs.
In April, Merck & Co, Inc. announced it was dropping development of a
PDE-4 inhibitor because of safety concerns.
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