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 FUZEON. This is likely to be driven by the unique mechanism of action of FUZEON and the activity of TMC114 against PI-resistant virus", commented Dr Anton Pozniak, the Chelsea and Westminster Hospital, London.

"We welcome Tibotec's launch of TMC114 and realize just how important an opportunity this is for patients facing HIV resistance who are in need of new options. With the compelling data and approval of TMC114 physicians can now aggressively pursue undetectable viral load and give their patients the best possible care," commented Jenny Edge-Dallas, Roche's newly appointed head of HIV.

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References:
1. Up until recently, failure to achieve an undetectable viral load in treatment-experienced patients has been reluctantly considered acceptable if immune function can be preserved. However, there are real risks associated with such a treatment strategy where patients' viral load remains detectable in their blood. Such patients face an increased likelihood of accumulating drug resistant mutations leading to a loss of future antiretroviral treatment options and a potential for a decrease in their quality of life associated with decreased CD4 cell counts and disease progression.
2. As recently as 2003, DHHS guidelines addressed the treatment of patients with extensive prior exposure to antiretrovirals by commenting that "viral suppression is often difficult or impossible to achieve," and emphasizing the preservation of immune function and prevention of disease progression as the primary goals of therapy in these patients.

Notes to Editors:

For further information on FUZEON and Roche in HIV, please visit http://www.roche-hiv.com/Newsandfeatures/fuzeon.cfm

Approved by the FDA in March 2003, FUZEON is the first and only fusion inhibitor for the treatment of HIV and works in a way that is different from other types of anti-HIV drugs. A product of Tibotec Pharmaceuticals Ltd., darunavir, also known as TMC-114 and the trade name PrezistaTM, is a member of the PI class and is reported to be active against virus that has developed resistance to other PIs.

The boosting of PIs is a therapeutic strategy wherein a small dose of ritonavir is given concurrently with another PI to pharmacologically enhance exposure to the latter PI through the inhibition of the enzyme cytochrome p450. Ritonavir boosting results in increased drug levels that can increase efficacy, decrease pill burden, add flexibility to the dosing schedule, and remove fasting restrictions. To indicate a PI has been boosted with ritonavir, the sign "/r is included after the PI's name.

All trademarks used or mentioned in this release are legally protected.

For more information, please contact:

Alexander Watson
Ketchum
Office: +44 207 611 3663
E-Mail: alexander.watson@ketchum.com

Janet Sanburg
F. Hoffmann-La Roche Ltd
Mobile: +41 792 559 414
Email: janet.sanburg@roche.com


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