Roche plant spared from sale runs into GMP issues
A South Carolina plant Roche ($RHHBY) had on the auction block last year has developed manufacturing issues that have interrupted production of its weight control drug Xenical.
Health officials in the U.S. and Europe have been notified, and the Swiss company is bringing in an expert to help it get a handle on "Good Manufacturing Practice (GMP) deficiencies discovered during an internal audit," the company said in a statement emailed to FiercePharmaManufacturing. No specifics were given.
The Florence, SC, plant manufactures intermediates and active pharmaceutical ingredients (API) used in Tamiflu, Xeloda, Xenical and Valcyte as well as the PEG reagent for Pegasys. The company said "based on the current benefit/risk assessment and high medical need for patients," it continues to release Xeloda, Pegasys, Valcyte, Tamiflu and previously released Xenical material. No recalls have been requested by authorities.
The plant, built in 1992, was one of 6 U.S. facilities targeted in late 2010 when the company announced it would close facilities and layoff 4,800 employees to save $2.4 billion by 2012. That is about half the $5.7 billion it bid last week for gene sequencer Illumina ($ILMN). In its earnings announcement Wednesday, the company reported net income last year rose to 9.5 billion Swiss francs ($10.3 billion) from 8.9 billion francs a year earlier. It said its cost-cutting had saved the company 1.8 billion francs last year and will lead to 2.4 billion francs in savings this year.
Cuts elsewhere apparently were enough to save the Florence plant, at least in the short term. Roche announced in July it would keep the plant open for now.