Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
PRNewswire - November 30, 2004
RIDGEFIELD, Conn., Nov. 30 /PRNewswire-FirstCall/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced the opening of the tipranavir Expanded Access Program (EAP) in the U.S., following the recent review of the protocol (1) by the U.S. Food and Drug Administration. The program will provide access to tipranavir for eligible HIV-infected patients who are not enrolled in the ongoing tipranavir clinical studies, who have demonstrated protease inhibitor (PI) resistance, and who need tipranavir to construct a viable treatment regimen. Tipranavir is a novel non-peptidic protease inhibitor currently in Phase 3 development.
For more information about the program, healthcare professionals treating HIV-infected patients may obtain information by calling 1-888-524-8675 or visiting http://www.tpv-eap.com or http://www.clinicaltrials.gov.
"Boehringer Ingelheim recognizes the urgent unmet need for drugs to combat strains of HIV that are resistant to currently available protease inhibitors," said Douglas Mayers, M.D., International Head, Therapeutic Area Virology, Boehringer Ingelheim. "We have worked diligently to provide early access to tipranavir to patients in the United States who need this drug to complete a viable treatment regimen."
The tipranavir EAP in the U.S. is available to HIV-infected patients at least 18 years old, who are triple-antiretroviral class-experienced with at least two previous PI-based regimens, and have documented PI-resistance. Eligibility is not dependent upon viral load or CD4+ cell count.
The U.S. EAP is part of a larger, international early access initiative, which will provide tipranavir to several thousand treatment-experienced patients worldwide. The tipranavir EAP is the result of a collaborative effort between Boehringer Ingelheim, local regulatory authorities and the HIV treatment advocacy community to make tipranavir available to HIV-infected patients in need of drugs to treat PI-resistant virus. Resistance to currently available anti-HIV drugs is an increasingly prevalent concern for HIV-infected patients worldwide. A recent large-scale study demonstrated that 41 percent of adults receiving care for HIV infection in the U.S. with a detectable viral load had PI-resistant virus. (2)
Tipranavir
Tipranavir is a non-peptidic protease inhibitor currently in Phase 3 of clinical development -- the final stage of testing prior to the submission of data to regulatory authorities for review and consideration for marketing approval. The 24-week data from two Phase 3 studies (RESIST-1 and RESIST-2) (3) formed the foundation of the New Drug Application for tipranavir, which was submitted to the Food and Drug Administration on October 22, 2004. Tipranavir does not cure HIV infection/AIDS or prevent transmission of HIV to others.
Boehringer Ingelheim
Boehringer Ingelheim is involved in basic research and is committed to the development of tipranavir and improving HIV therapy by providing physicians and patients with innovative antiretrovirals. For more information on Boehringer Ingelheim Pharmaceuticals, Inc., please visit http://us.boehringer-ingelheim.com.
Contact:
Ann Davin, Public Relations Manager
Boehringer Ingelheim Pharmaceuticals, Inc.
900 Ridgebury Road
Ridgefield, CT 06877
Phone: (203) 791-6318 - Fax: (203) 791-6442
E-mail: adavin@rdg.boehringer-ingelheim.com
Lauren Hess, GCI Group
825 Third Avenue
New York, NY 10022
Phone: (212) 537-8242 - Fax: (212) 537-8250
lhess@gcigroup.com
Notes: (1) Boehringer Ingelheim provides tipranavir in the EAP under a treatment IND. Treatment INDs enable patients to access investigational drugs intended to treat serious and life-threatening diseases, in the absence of other therapeutic options.
(2) D. Richman, et al. The prevalence of antiretroviral drug resistance in the United States. AIDS. 18(10):1393-1401, July 2, 2004.
(3) Randomized Evaluation of Strategic Intervention in Multi-Drug ReSistant Patients with Tipranavir (RESIST)
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
Web Site: http://www.tpv-eap.com http://www.clinicaltrials.gov
http://us.boehringer-ingelheim.com
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