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

February 16, 2007

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."

1. Lohse N, Kronborg G, Gerstoft J, et al. Virological control during the first 6-18 months after initiating highly active antiretroviral therapy as a predictor for outcome in HIV-infected patients: a Danish, population-based, 6-year follow-up study. CID 2006; 42:136-144.

2. Youle M, Staszewski S, Clotet B et al. Concomitant use of an active boosted protease inhibitor with enfuvirtide in treatment-experienced, HIV-infected individuals: recent data and consensus recommendations. HIV Clinical Trials 2006: 7: 86-96.

3. The Panel on Clinical Practices for Treatment of HIV Infection convened by the Department of Health and Human Services (DHHS). Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. May 4, 2006 (accessed August 10 2006).

4. Recommandations du groupe d'experts sous la direction du Professeur Patrick Yeni réalisé avec le soutien du Ministère de la Santé et des Solidarités. Prise en charge médicale des personnes infectées par le VIH. 2006: 46.

5. Hammer SM, Saag MS, Schechter M et al. Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society - USA panel. JAMA, 2006;296:827-843.

6. British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy. British HIV Association HIV Medicine (2006) 7, 494.

Notes to Editors:

For further information on FUZEON and Roche in HIV, please visit:

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. Darunavir, also known as TMC 114 and the trade name Prezista™, is a product of Tibotec Pharmaceuticals Ltd., a division of Janssen-Cilag. Darunavir 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:

Janet Kettels
Hoffmann-La Roche Inc
Office: +1 973 235 4093
Mobile: +1 862 596 9084

Ketchum UK

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