Tibotec Pharmaceuticals Announces Agreement to Develop and Commercialize a New Fixed-Dose Combination of TMC278 And Truvada® With Gilead Sciences
Product Could Represent a New, Once-Daily Antiretroviral Treatment Option
Cork, Ireland, July 16, 2009 - Tibotec Pharmaceuticals today announced that it has entered into a license and collaboration agreement with Gilead Sciences, Inc. for the development and commercialization of a new once-daily fixed-dose antiretroviral product containing Tibotec's investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride 25 mg) and Gilead's Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) for treatment-naïve adult patients with HIV-1. Fixed-dose combinations contain multiple medicines formulated into one tablet and help to simplify HIV therapy.
"A simplified regimen may help improve patient adherence and decrease overall pill burden," said Roger Pomerantz, MD, President Tibotec R&D. "We are very pleased to collaborate with Gilead, one of the leading companies in the fight against HIV/AIDS, and look forward to advancing this new fixed-dose product in addition to TMC278 as a single agent."
This agreement represents the first fixed dose combination product collaboration for Tibotec and, when approved, it would become the first complete once-daily antiretroviral treatment regimen for HIV to include an antiretroviral from Tibotec. Tibotec is currently studying the combination of Truvada and TMC278 in its Phase III program; the two ongoing pivotal clinical trials, TMC278-C209 and TMC278-C215 are fully recruited having enrolled over 1,300 treatment-naïve adult patients with HIV-1. Current HIV treatment guidelines issued by the U.S. Department of Health and Human Services list emtricitabine and tenofovir (the components of Truvada) in combination with a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor as a preferred regimen for patients initiating therapy.
Tibotec will remain uniquely responsible for the commercialization of TMC278 as a single product and additionally will have the right to promote the fixed-dose combination product to healthcare professionals in all countries except Japan and the access countries. Gilead will assume the lead role in manufacturing, registration and, subject to regulatory approval, commercialization of the fixed-dose combination of TMC278 and Truvada throughout the territory.
Tibotec and Gilead are committed to working together to make the fixed-dose combination of TMC278 and Truvada available in the developing world and will work towards a separate agreement for these countries.
TMC278 is an investigational non-nucleoside reverse transcriptase inhibitor, and the safety and efficacy of it, in combination with other antiretroviral agents, has not been established. Two major phase III trials for TMC278 are currently being conducted in the United States, Canada, Africa, Asia, Europe and South America.
About Tibotec Pharmacetucials
Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Tibotec Pharmaceuticals is a subsidiary of Johnson & Johnson.
Forward looking statements:
(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 Inc.'s, Janssens Pharmaceutica N.V.'s 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 December 28, 2008. 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. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.)