Closure of the tipranavir POTENT trial

Ingelheim/Germany, 09 June 2008 - After careful consideration of the feasibility of meeting the enrolment targets for the POTENT (Prospective Evaluation Of Tipranavir versus darunavir in treatment-Experienced patieNTs) trial, Boehringer Ingelheim has terminated the study. The trial has not been halted due to any safety or efficacy reasons. POTENT was designed to compare the efficacy and safety of Aptivus® (tipranavir) versus darunavir, both with ritonavir as part of combination antiretroviral therapy.

The success of modern HIV treatments including nevirapine has reduced the number of patients experiencing virologic failure on their earlier regimens and the duration of treatment in any line has increased. This is excellent news for those with HIV, but it also means that the original recruitment goals for the trial, to recruit 800 patients who had previous treatment with at least three classes of HIV therapies and demonstrated resistance to more than one protease inhibitor drug, was simply unfeasible. It is estimated that the trial would need to be open for 10 years to accrue the patient numbers required in order to have a meaningful result.

Boehringer Ingelheim remains committed to improving HIV therapy by providing physicians and patients with innovative antiretroviral treatment options. Aptivus®, a non-peptidic protease inhibitor which works by inhibiting the viral protease, an enzyme needed to complete the HIV replication process, remains a valuable option for treatment-experienced patients, helping them achieve and sustain viral undetectability in patients resistant to multiple protease inhibitors. Viramune® (nevirapine) is a product of original research done at Boehringer Ingelheim and was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs on the market.