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European approval of HIV drug darunavir will provide a potent new option with Fuzeon

Basel (CH), 16 February 2007. Today's conditional marketing authorisation in the European Union of the new protease inhibitor (PI) darunavir (boosted with ritonivir) provides physicians with the opportunity to build a potent new treatment combination with the fusion inhibitor, FUZEON. The combination of FUZEON and boosted darunavir has been shown to give treatment-experienced patients a better chance of achieving an undetectable viral load than boosted darunavir without FUZEON. This crucial goal of therapy is associated with a better outlook1 but has for a long time been considered an unrealistic goal for patients with resistance to many HIV medications.

"It is clear that in 2007 we are entering a new era where an undetectable viral load is the primary objective for all treatment-experienced patients," said Dr Anton Pozniak, consultant physician from the Chelsea and Westminster Hospital, London. "The availability of new active therapies such a darunavir/r, in combination with FUZEON, gives patients a better chance of achieving this goal."

The growing body of evidence from studies such as TORO 1 and 2, RESIST 1 and 2, POWER 1 and 22 has prompted influential international guidelines to recommend combining drugs with a new mechanism of action such as FUZEON, with an active boosted PI, such as darunavir/r, as one of the best approaches to achieving an undetectable viral load in treatment-experienced patients. 3, 4, 5, 6 The consequences of maintaining a patient on a failing regime includes the emergence of drug resistance and the swift loss of much needed active treatments.

Dr Malte Schutz, International Medical Leader at Roche, further commented: "We welcome the European approval of Tibotec's drug, darunavir/r, and understand that this is an important development for patients faced with multiple drug resistance who are most in need of new treatment options."


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Contact: Peter Impey
peter.impey@ketchum.com
44-207-611-3589
Ketchum
16-Feb-2007


Page: 1

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