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Boehringer Ingelheim Announces U.S. Expanded Access Program for Anti-HIV Drug Tipranavir
  -- Program Will Provide Drug to HIV-Infected Patients with Limited Treatment Options --
Ridgefield, CT, November 30, 2004 -- 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 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 www.tpv-eap.com or 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.
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) formed the foundation of the New Drug Application for tipranavir, which was submitted to the Food and Drug Administration on October 22, 2004.
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
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