U.S. Seizes Batches of Two Glaxo Drugs

[carolina]

U.S. Seizes Batches of Two Glaxo Drugs
Fri Mar 4, 4:09 PM ET
By Tim Dobbyn

WASHINGTON (Reuters) - U.S. officials on Friday seized batches of GlaxoSmithKline Plc's diabetes drug Avandamet and controlled-release antidepressant Paxil CR because of concerns over manufacturing quality.

The U.S. Food and Drug Administration (news - web sites) saw no immediate risk to consumers from the two drugs made by Europe's biggest drugmaker but said the manufacturing failed to meet standards for safety, strength, quality and purity.

Patients were advised to continue taking their medication but talk to their doctor about possibly using alternative drugs until the manufacturing problems are corrected.

"FDA (news - web sites) and the Department of Justice (news - web sites) will not allow drug manufacturers to ignore our high public health standards for drug manufacturing," said John Taylor, FDA Associate Commissioner for Regulatory Affairs.

The European Medicines Agency said no recall of products was envisaged in Europe at present. Glaxo had informed the agency that none of the batches seized had been supplied to the European market.

The FDA found that Paxil CR tablets could split, possibly giving patients a portion lacking any active ingredient or active ingredient without controlled release.

In addition, some Avandamet tablets did not have an accurate dose of rosiglitazone, an active ingredient.

A spokesman for Glaxo in London said it was too early to assess the financial impact of the seizures.

Glaxo shares closed down 2.2 percent at 12.89 pounds in London, reversing earlier gains that had taken the stock to a 15-month high on hopes for its new drug pipeline, particularly cervical cancer vaccine Cervarix.

Glaxo stock fell further on the New York Stock Exchange (news - web sites), down 4 percent in afternoon trading.

Shares of SkyePharma Plc, a drug delivery specialist that developed the controlled-release technology in Paxil CR, ended off 13.7 percent at 52 pence in London. SkyePharma receives a low single-digit percentage royalty on sales of Paxil CR.

Glaxo said it was working to resolve manufacturing problems as quickly as possible but said both drugs would be in short supply in the United States in the short term.

The seizures were executed by the U.S. Marshals Service at GlaxoSmithKline's Cidra, Puerto Rico manufacturing facility, and a distribution facility in Knoxville, Tennessee and one in Puerto Rico, the FDA said.

There have been FDA inspections for some time at the Cidra plant, as Glaxo highlighted when it announced full-year results last month. The factory is the only source of supply of both drugs for the U.S. market.

The facility also makes a number of other medicines, including heart failure treatment Coreg, but the spokesman said they were not affected by the move and the FDA was not investigating other product lines.

The European Medicines Agency said European officials would soon inspect Glaxo's Puerto Rico factory.

Mike Ward, an industry analyst with Code Securities in London, said investors were clearly jolted by the news but he took comfort from the fact that no harm appeared to have been done to consumers.

"Market-makers in the stock are obviously worried but, as far as we can tell, there is no problem with any patients having suffered," he said. (Additional reporting by Ben Hirschler in London, editing by Chizu Nomiyama, Reuters Messaging: timothy.dobbyn.reuters.com@reuters.net; email: timothy.dobbyn@reuters.com +1 202 898 8362))