Navigation Links
Tibotec Pharmaceuticals Announces Agreement to Develop and Commercialize a New Fixed-Dose Combination of TMC278 and Truvada(R) With Gilead Sciences
Date:7/16/2009

CORK, Ireland, July 16 /PRNewswire/ --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-naive 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-naive 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.

About TMC278

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 Pharmaceuticals

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 Statement

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'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 31, 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.

    CONTACTS:
    Tibotec
    Louise Mehrotra, Investor Relations
    (732) 524-6491

    Karen Manson, Media
    +44 1737 644 690 office
    +32 479 89 47 99 mobile


'/>"/>
SOURCE Tibotec Pharmaceuticals
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. AHF Criticizes Tibotec Over Steep Price for Newest AIDS Drug, Etravirine
2. Tibotec Conducts Two Pivotal Phase III Clinical Trials Studying TMC278 in Treatment-Naive Adults with HIV
3. Ninety-Six Week Data on Tibotec Investigational NNRTI, TMC278, Presented at AIDS 2008
4. Tibotec Presents Interim Findings for TMC435, an Investigational Genotype 1 Hepatitis C Treatment, at the AASLD Liver Meeting 2008
5. Tibotec Data Presented at ICAAC and HIV9 Follow Key Regulatory Approvals for Anti-HIV Compounds
6. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
7. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
8. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
9. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
10. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
11. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... May 25, 2016 Digital Health Dialog, ... it by the US Patent and Trademark Office ... includes proprietary processes for electronic opt-­in and processing ... wellness programs, HIPAA compliance and otherwise. ... "Our technology allows for individuals ...
(Date:5/24/2016)... Cirujanos holandeses han puesto en ... médicos a compartir sus mejores prácticas por el mundo ... médicos de Europa, África, Asia ... aplicación, que combina la transmisión en vivo con mensajería ... Educación   "Imagine un médico de Medicines ...
(Date:5/24/2016)... 24, 2016  NxStage Medical, Inc. (Nasdaq: ... advancing renal care, today announced that Jeffrey H. ... the following schedule of investor conferences. Where applicable, a ... http://ir.nxstage.com/ .   ... NY, NY           Friday, June 10, 2016 1:30 p.m. ...
Breaking Medicine Technology:
(Date:5/30/2016)... ... ... Another ER facility operated by First Choice Emergency Room opened yesterday ... is open 24 hours daily. , First Choice Emergency Room hosted a ribbon cutting ... High School band entertained attendees and accepted First Choice Emergency Room’s donation on behalf ...
(Date:5/28/2016)... ... May 28, 2016 , ... "Color Grading media can be time ... preset onto their media," said Christina Austin - CEO of Pixel Film Studios. ... and easily add stylish color grades to their footage. A LUT is a Lookup ...
(Date:5/27/2016)... ... May 27, 2016 , ... Southland Log Homes , designer and ... frame barn kits, which can be found on its website at SouthlandLogHomes.com. , The ... plans, and they highlight the craftsmanship of timber post and beam construction. The ...
(Date:5/27/2016)... (PRWEB) , ... May 27, 2016 , ... This campaign ... a stroke, which we as a society can control and change. , As nearly ... nearly every 40 seconds within the United States. Plus, with an estimated 129,000 of ...
(Date:5/27/2016)... New York, NY (PRWEB) , ... May 27, 2016 , ... ... bolstered by inspiring human interest stories, which come courtesy of leaders in the nursing ... within the industry, from leading advocates and associations—namely Abilene Christian University. , As ...
Breaking Medicine News(10 mins):