Roche Pharmaceuticals

Tipranavir's EU Approval Provides a New Active Drug to be Combined with FUZEON(R) for HIV Patients Facing Resistance

Basel, Switzerland (ots/PRNewswire) - Following today's European approval of Boehringer Ingelheim's boosted protease inhibitor tipranavir (APTIVUS(R)), European patients now have the chance to benefit from the potent combination of the fusion inhibitor FUZEON (enfuvirtide) and boosted tipranavir in addition to their current treatment regimen. The clinical trials RESIST I and II showed that almost double the proportion of patients who received FUZEON plus tipranavir/r showed a 90 percent drop in viral load compared with patients not receiving FUZEON. This FUZEON effect was shown in other clinical trials combining FUZEON with other boosted protease inhibitors, including lopinavir/r and TMC 114/r. The use of FUZEON with tipranavir for the management of treatment-experienced patients was supported by recently updated treatment guidelines by the Department of Health and Human Services in the US, where tipranavir has been available to patients since June 2005. For the first time, the guidelines also recommended the treatment goal of achieving suppression of the virus to levels that make it undetectable in the blood for these patients. Notes to Editors: Growing Body of Evidence, RESIST 1&2 / POWER 1&2 / TORO 1&2 - Collectively the data from all six studies, in over 2,500 patients, establish a new paradigm in the management of triple class-experienced patients. RESIST Phase III tipranavir trials - Over 24 weeks, almost double the proportion of patients who received FUZEON plus boosted tipranavir showed a 90% drop in viral load compared with patients not receiving FUZEON POWER Phase II TMC114 dosing trials - Over 24 weeks in the combined TMC114 trials, almost double the proportion of patients who received FUZEON plus boosted TMC114 achieved a viral load below 50 copies/ml compared with patients not receiving FUZEON - A remarkable 67% of the patients receiving FUZEON plus boosted TMC114 reached an undetectable viral load TORO Phase III FUZEON trials - Over 24 weeks, double the proportion of patients who received FUZEON plus boosted lopinavir achieved an undetectable viral load (<50 copies/ml) compared with patients not receiving FUZEON Recommendations - The updated DHHS guidelines (October 6, 2005) are available online: http://aidsinfo.nih.gov/guidelines/. The Panel on Clinical Practices for Treatment of HIV Infection of the US Department of Health and Human Services (DHHS) focuses on the overall management of treatment-experienced patients. It also provides guidance on changing an antiretroviral therapy regimen for virologic failure, for which the latest recommendations include: - Using the treatment history and past and current resistance test results to identify active agents (preferably at least two fully active agents) to design the new regimen. A fully active agent is one likely to demonstrate antiretroviral activity on the basis of both the treatment history and susceptibility on drug-resistance testing. - Adding a drug with activity against drug-resistant virus (e.g. a potent ritonavir-boosted PI) and a drug with new mechanism of action (e.g. HIV entry inhibitor) to an optimised background antiretroviral regimen can provide significant antiretroviral activity. 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. ots Originaltext: Roche Pharmaceuticals Im Internet recherchierbar: http://www.presseportal.ch Contact: For more information, please contact: Laura Bertossi, Ketchum, Office: +44-207-611-3597 E-Mail: laura.bertossi@ketchum.com Janet Sanburg, F. Hoffmann-La Roche Ltd, Mobile: +41-79-255-9414 Email: janet.sanburg@roche.com

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