The pharmaceuticals giant said that the launch of its promising impotence drug on the U.S. market will be delayed into 2003 following a request by the FDA for additional studies.
The FDA decision will push the launch date of the product into 2003.
Pharmaceuticals giant Bayer AG said Wednesday that the U.S. launch of its most promising new product will be delayed pending more clinical data.
The U.S. Food and Drug Administration stamped Bayer's erectile dysfunction drug Vardenafil as "approvable" but asked for additional clinical pharmacology studies before it grants the final go-ahead.
The decision will push the launch date of the product into 2003 instead of the final quarter of this year, as Bayer had originally targeted.
Bayer’s marketing partner for the drug, Britain’s Glaxo Smithkline Plc, said it expected the launch date to be postponed “by several months”.
Analysts said that further studies of Vardenafil will also add to the cost of the project and likely force a revision of sales and earnings estimates.
Bayer is under pressure to fill its pipeline after the highly publicized withdrawal of its anti-cholesterol drug Baycol last year, and the threat of generic competition. It had hoped to get Vardenafil on the erectile dysfunction market ahead of another new product to be launched by Eli Lilly & Co. and Icos Corp.
The FDA has also requested more data from Eli Lilly and Icos on their drug Cialis, which had been targeted for launch in the second half of 2002 but which has also been delayed due to some outstanding labeling, manufacturing and pharmacological issues.
“The prospect of approval is a partial victory [for Bayer],” said M.M. Warburg analyst Ulrich Huwald. But he added that as a result of the delay, the race between Eli Lilly and Bayer for market entry was again wide open. Both companies are challenging U.S. giant Pfizer, which launched its erectile dysfunction drug, Viagra, in 1998.