Tibotec Data Presented at ICAAC and HIV9 Follow key Regulatory Approvals for Anti-HIV Compounds
New Findings From ARTEMIS and TITAN Studies Demonstrate Growth of the Tibotec Virology Franchise
Glasgow, Scotland (November 12, 2008) - New data on PREZISTA(R) (darunavir), a protease inhibitor from Tibotec, will be presented at the Ninth International Congress on Drug Therapy in HIV Infection (HIV9) in Glasgow, U.K., from 09-13 November 2008. The company also presented new data on PREZISTA(R) at the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, D.C., from 25-28 October 2008. These presentations follow key regulatory approvals and decisions for PREZISTA(R) and INTELENCE(TM) (etravirine), a next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI). The company continues to research various compounds in hepatitis C, tuberculosis and HIV.
"The Tibotec data being presented at HIV9 culminate an exciting three months for the company and for the entire HIV community," said Roger Pomerantz, President, Tibotec Research & Development. "The data we've amassed and the regulatory milestones we've achieved this year are signs of our dedication to finding innovative ways to meet the needs of people with HIV."
Recent Regulatory Milestones for Tibotec in HIV
-- 28 August 2008 - The European Commission approved etravirine, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients.
-- 21 October 2008 - The U.S. FDA granted traditional approval to darunavir, coadministered with low dose ritonavir, for twice-daily use in treatment-experienced adult patients, as well as an expanded indication for once-daily dosing as part of HIV combination therapy in treatment-naïve adults (those who have never taken HIV medication before).
-- 23 October 2008 - Darunavir received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) to extend the drug's indication to treat human immunodeficiency virus (HIV-1) infection to include treatment-experienced adult patients. Darunavir, coadministered with low dose ritonavir, is currently indicated for the treatment of HIV-1 in combination with other antiretroviral medicines in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor.
Tibotec Data at ICAAC and HIV9 Data from multiple studies examining the use of darunavir in patients with varying levels of treatment experience were presented at ICAAC and will be presented at HIV9. Highlights include:
-- A new analysis of ARTEMIS (AntiRetroviral Therapy with TMC114 ExaMined In Naive Subjects), a randomised, controlled, open-label Phase III trial that compares the 96-week efficacy and safety of darunavir/ritonavir with lopinavir/ritonavir in treatment-naive adults. ARTEMIS is the first study to examine darunavir/ritonavir in a once-daily dose in treatment-naive patients with HIV. These data were presented at ICAAC on 26 October.
-- A new analysis of TITAN (TMC114/r In Treatment-experienced pAtients Naive to lopinavir), a randomised, controlled, open-label Phase III study that compares the 96-week efficacy and safety of darunavir/ritonavir with lopinavir/ritonavir in treatment-experienced, lopinavir-naive patients. These data will be presented at HIV9 on 13 November.
The ARTEMIS and TITAN studies are ongoing. Darunavir and etravirine were developed by Tibotec Pharmaceuticals, Cork, Ireland. Tibotec, a division of Janssen-Cilag, is responsible for marketing the brand in Europe.
Please see full Prescribing Information for more details.
About Tibotec PharmaceuticalsTibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and development company, with offices in Yardley, PA and main research and development operations/labs in Belgium. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
About Tibotec
Tibotec, a division of Janssen-Cilag, will bring innovative products for HIV/AIDS to patients in Europe, the Middle East and Africa This new division was created within the Janssen-Cilag companies in October 2005 to focus on patients' and healthcare providers' specific needs in this disease domain. The company will also commercialise medicine to combat other viral diseases in the future.
Janssen-Cilag
Janssen-Cilag is a leader in traditional and biological medicines for disorders such as gastroenterology, women's health, mental health and neurology as well as for pain, oncology, haematology and nephrology.
Posted: November 2008
