, July 26
/PRNewswire/ -- Tibotec Pharmaceuticals today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TMC278 (rilpivirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults. If approved, TMC278 will be the third anti-HIV compound to be introduced by Tibotec Pharmaceuticals.
The regulatory application is based on the 48-week results of two pivotal Phase 3 double-blind, randomized studies, known as ECHO (TMC278-TiDP6-C209) and THRIVE (TMC278-TiDP6-C215), which evaluated the efficacy, safety and tolerability of once-daily TMC278 in treatment-naïve HIV-1-infected adults.
ECHO (Efficacy Comparison in treatment-naive HIV-infected subjects Of TMC278 and EFV) evaluated TMC278 (25 mg) once daily oral tablet versus efavirenz (EFV) (600 mg) once daily, combined with a fixed background regimen consisting of emtricitabine + tenofovir disoproxil fumarate. THRIVE (TMC278 against HIV, in a once daily RegImen Versus Efavirenz) evaluated TMC278 (25 mg) once daily versus EFV (600 mg) once daily, combined with an investigator-selected background regimen consisting of two N[t]RTIs (abacavir + lamivudine or emtricitabine + tenofovir disoproxil fumarate or zidovudine + lamivudine). The studies were conducted at more than 100 sites in more than 20 countries, and enrolled 1,368 patients.
"The U.S. regulatory submission for TMC278 is an important step forward as Tibotec broadens its HIV treatment portfolio," said Eric Lefebvre, the Director of Global Medical Affairs at Tibotec. "It is our goal to help as many patients as possible receive the treatment and care that they need. Upon approval, TMC278 may provide a new option for many patients starting treatment for the first time."
Pending FDA approval, Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., will commercialize TMC278 in the United States. Regulatory submissions for TMC278 in other countries are expected in coming months. Tibotec has also entered into a license and collaboration agreement with Gilead Sciences, Inc. (Nasdaq: GILD) for the development and commercialization of a once-daily fixed-dose combination of TMC278 and Gilead's Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
About Tibotec Pharmaceuticals
Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Beerse, Belgium, with offices in Titusville, NJ, USA. 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 Therapeutics
Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., headquartered in Titusville, NJ, is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.
Tibotec Pharmaceuticals and Centocor Ortho Biotech Products, L.P. are subsidiaries of Johnson & Johnson.
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Tibotec BVBA and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Tibotec BVBA nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.
Truvada is a registered trademark of Gilead Sciences, Inc.
Pamela Van Houten
SOURCE Tibotec Pharmaceuticals