Roche Holding Ltd. : Roche Pharmaceutical Plant In US Hit By Production Problems
01/26/2012 | 02:15am
(This article was originally published Wednesday.)
Swiss pharmaceuticals giant Roche Holding AG (ROG.VX) has been hit by production problems at one of its U.S. factories.
The company is no longer releasing its anaemia drug Mircera and Xenical obesity drug to the market after the problems were discovered at the factory in Florence, South Carolina.
The factory produces ingredients for the two drugs as well as for other pharmaceuticals, including flu treatment Tamiflu, cancer treatment Xeloda, HIV treatment Valcyte and Pegasys, which is used to treat hepatitis C.
Roche discovered the deficiencies in its "Good Manufacturing Practice" at the site during an internal audit in December.
The company informed health authorities about the situation and agreed with them to continue to release all the products except Mircera and Xenical to the market.
"As a result, some markets may experience shortages or stock-out of Mircera and Xenical, and Roche is informing stakeholders accordingly," Roche spokesman Daniel Grotzky told Dow Jones Newswires.
"As of today health authorities have not requested withdrawal or recall of products that are on the market," he added.
Xenical had sales of 337 million Swiss francs in 2010, while Mircera had sales of CHF237 million in the third quarter of 2011.
Xeloda is still being released from the site, while Tamiflu and Valcyte are being produced at other sites, Grotzky said.
The company has asked an outside consultancy to investigate the problems.
The plant is operating at reduced capacity while the investigation, which is being carried out by Lachman Consultants, is underway.
Roche, which reports its 2011 results on Feb. 1, doesn't expect a material financial impact in 2012 from the situation, Grotzky said.
Earlier this month, competitor Novartis AG (NVS) temporarily suspended production at a facility in Nebraska after clients complained of broken pills and mixed tablets in a bottle.
The company took a one-time charge of $120 million related to a recall and improvement efforts.
-By John Revill, Dow Jones Newswires; +41 43 443 8042 ; john.revill@dowjones.com
