tipranavir

RIDGEFIELD, Conn., October 25, 2004 -- Boehringer Ingelheim Pharmaceuticals,Inc tipranavir. today announced the submission of a New Drug Application (NDA) to the U.S tipranavir. Food and Drug Administration (FDA) for tipranavir tipranavir. The Company is seeking acceleratedapproval of tipranavir and has requested a priority, six-month review of theNDA tipranavir. Priority review designation is based upon whether a drug provides a significantimprovement in the treatment of a serious or life-threatening disease tipranavir. Tipranaviris a non-peptidic protease inhibitor under investigation for the treatment ofHIV-1 infection in combination with other antiretroviral agents.

"Boehringer Ingelheim has worked diligently to develop tipranavir as quicklyas possible in response to the urgent need for new therapies for treatment-experiencedHIV-positive patients," said Paul Fonteyne, Executive Vice President andHead of Sales & Marketing at Boehringer Ingelheim Pharmaceuticals, Inc.

Two large-scale Phase 3 clinical trials, RESIST-1 and RESIST-2,1 form the foundationof the NDA for tipranavir tipranavir. These studies are randomized, controlled, open-labeltrials designed to examine the safety and efficacy of tipranavir, boosted withlow-dose ritonavir (tipranavir/r), versus a low-dose ritonavir-boosted comparatorprotease inhibitor in treatment-experienced patients tipranavir. Interim data from RESIST-1will be presented at the 44th Interscience Conference on Antimicrobial Agentsand Chemotherapy in Washington, DC on October 31.

"The number of treatment-experienced HIV-infected patients in the U.S tipranavir. continues to grow," said Dr tipranavir. Kathleen Squires, Associate Professor of Medicineat the Keck School of Medicine at the University of Southern California andMedical Director at the Rand Schrader Clinic of the LAC + USC Medical Center tipranavir. "Tipranavir may offer an important option for those who need new therapyto stay ahead of HIV drug resistance."

Tipranavir
Tipranavir is a non-peptidic protease inhibitor currently in late Phase 3 clinicaldevelopment -- the final stage of testing prior to the submission of data tothe FDA for review for marketing approval tipranavir. Tipranavir is also being evaluatedfor use in pediatric and treatment-naive patient populations in Phase 2 and3 studies that are currently underway.

The investigational drug, tipranavir, does not cure HIV infection/AIDS or preventtransmission of HIV to others.

Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development of novel antiretroviralagents tipranavir. Viramune (nevirapine), a product of original research done at BoehringerIngelheim, was the first member of the non-nucleoside reverse transcriptaseinhibitor (NNRTI) class of anti-HIV drugs tipranavir. Boehringer Ingelheim is involvedin basic research and is committed to the development of tipranavir and improvingHIV therapy by providing physicians and patients with innovative antiretrovirals.

For more information on Boehringer Ingelheim Pharmaceuticals, Inc., pleasevisit us.boehringer-ingelheim.com.

Notes:
1 The RESIST (Randomized Evaluation of Strategic Intervention in Multi- DrugReSistant Patients with Tipranavir) clinical trial program is one of the largeststudy programs undertaken with an investigational antiretroviral agent in patientspreviously treated with multiple combinations of antiretroviral drug regimens.

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