AEGiS-Reuters: Roche blood screening system wins FDA approval

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Roche blood screening system wins FDA approval

Reuters NewMedia - Thursday December 05, 2002


ZURICH, Dec 5 (Reuters) - The U.S. Food and Drug administration has approved Roche Holding AG's ROCZg.VX COBAS AmpliScreen blood screening system, the Swiss healthcare group said on Thursday.

Roche, which has the world's leading diagnostics business, said this was an important milestone for its blood screening products that use polymerase chain reaction technology, which quickly amplifies genetic material to detect disease.

The AmpliScreen system is designed to be used with tests for hepatitis C and human immunovirus (HIV) that are still awaiting final U.S. regulatory approval but have been in use since 1999 under investigational new drug applications.

The tests are already available in several European countries.

The approval came two days after the FDA approved Roche's Pegasys drug in combination with standard anti-viral therapy to treat hepatitis C, an infection that attacks the liver.

Roche bills Pegasys as a potential blockbuster with peak annual sales of $1 billion.

Geneva-based private bank Pictet said Roche's chief financial officer Erich Hunziker had given an upbeat presentation to an investors gathering Pictet hosted on Wednesday, citing Pegasys's strong market penetration in Germany and Britain.

He also said HIV drug Fuzeon, being developed with Trimeris Inc TRMS.O , was likely to win regulatory approval early next year and confirmed it would have enough production capacity for 20,000 to 25,000 patients by 2003, Pictet said.

"Momentum for Roche is improving on the pharmaceuticals front, and diagnostics is already in a strong growth phase," Pictet added, suggesting growth in Roche's core earnings would significantly outpace the sector in the years ahead.

Roche certificates, which have outperformed the European healthcare sector by more than a fifth this year, were down 1.9 percent to 104 Swiss francs by 1525 GMT.


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