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World's first approval of new HIV drug TMC114 provides potent new treatment option with FUZEON

Basel (CH), 23 June 2006. The US approval of TMC114 (darunavir), a new boosted protease inhibitor (PI), provides the opportunity to build a potent new treatment combination with the fusion inhibitor FUZEON (enfuvirtide) that can successfully combat the HIV virus in treatment resistant patients.

Data have shown that up to two-thirds of patients with extensive prior exposure to anti-HIV drugs achieved undetectable levels of virus (less than 50 copies of viral RNA per ml of blood) when darunavir was used with FUZEON - a result that has never been seen before in this patient population.

"The benefits of adding one new drug, such as darunavir/r, to a failing regimen could be short-lived and result in what is called 'virtual monotherapy.' It is vitally important that patients who have developed resistance to a significant number of the available antiretroviral medications start at least two fully active drugs to maximize their chances for treatment response and survival," said Nelson Vergel, an HIV treatment advocate who founded SalvageTherapies.org and has been living with the disease for more than 20 years. "This principle has been further substantiated by the excellent clinical results with the combination of FUZEON and darunavir/r."

The goal of reaching an undetectable viral load has been clearly considered possible for previously untreated or minimally pre-treated HIV patients. For the first time in late 2005, the U.S. Department of Health and Human Services (DHHS) guidelines established that maximal suppression of HIV was the goal for treatment-experienced patients and recommended using FUZEON with an active boosted PI, such as darunavir, as a strategy to achieve this goal.1,2 Until then, achieving an undetectable viral load in these patients had not been considered a realistic target.

"I have treated people living with HIV for many years who, for the first time, achieved undetectable viral levels with the combination of TMC114 and F
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Contact: Alexander Watson
alexander.watson@ketchum.com
44-207-611-3663
Ketchum
23-Jun-2006


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