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Europe approves new Roche arthritis drug
ZURICH/LONDON - Roche Holding AG has won final approval to sell its new rheumatoid arthritis drug, RoActemra, in Europe, the Swiss drugmaker said on Wednesday.
The green light from the European Commission had been expected following a positive opinion from the London-based European Medicines Agency in November, but still boosted Roche's stock.
RoActemra, which is known as Actemra in other markets, is viewed by Roche as a potential blockbuster. The company's stock rose 1.1 percent to 172.10 Swiss francs by 0946 GMT, versus a 1.1 percent drop in the European healthcare sector.
"After investors tried to play the fallen angels at the start of the New Year, defensive sectors such as Pharma are now en vogue again," analysts at Julius Baer said in a note about Roche.
The drug is already available in Japan, where it is sold by Roche's partner Chugai Pharmaceutical Co Ltd, but it has yet to be approved in the United States.
The U.S. Food and Drug Administration last month requested additional animal model data -- but not further clinical studies -- before approving the medicine. Roche expects to supply the requested information to the FDA in the third quarter of 2009.
Vontobel analyst Andrew Weiss, who estimates peak Actemra sales at 1.2 billion francs ($1.1 billion), said the approval was a good sign for Roche's filing with the U.S. Food and Drug Administration.
"The EMEA green light is a clear sign that the FDA is overly cautious. Roche however will need to conduct the trial and then file the data. We expect U.S. approval in 2010," Weiss said.
Known chemically as tocilizumab, Actemra is an anti-interleukin-6 receptor antibody and works in a different way than the existing multibillion-dollar-selling class of biotech drugs for arthritis that block an inflammatory protein called tumor necrosis factor (TNF).
Roche believes Actemra will become an important alternative treatment to anti-TNF drugs, helping diversify its business and reduce reliance on cancer medicines.
It will compete against Roche's own established medicine, Rituxan, which is already given to anti-TNF drug non-responders.
Rheumatoid arthritis -- characterised by inflammation of the membrane lining joints throughout the body, which can cause pain and stiffness and disability -- is estimated to affect more than 20 million people worldwide.
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