Navigation Links
FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125

- The Prescription Drug User Fee Act (PDUFA) user fee goal date will be

January 18, 2008 -

YARDLEY, Pa., Sept. 20 /PRNewswire/ -- Tibotec Pharmaceuticals Ltd. today announced that the New Drug Application (NDA) for TMC125 (etravirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), has been accepted for priority review by the United States Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) user fee goal date for the NDA for TMC125, the date by which the FDA must announce its decision regarding the application, will be January 18, 2008.

The NDA for TMC125, the first NNRTI to show antiviral activity in patients with documented NNRTI resistance, is based on the 24-week efficacy and safety results of two ongoing Phase III randomized, double-blinded, placebo- controlled studies, known as DUET-1 and DUET-2. The DUET studies examined the use of TMC125 in combination with other antiretroviral agents in adult treatment-experienced HIV-1 patients. The safety and efficacy of TMC125 in combination with other antiretroviral agents has not been established.

TMC125 is currently available through an expanded access program (EAP) in the United States, as well as a number of European countries and Canada. The EAP provides access to TMC125 to HIV-1 infected adults, at least 18 years old, who have limited treatment options either due to virological failure or intolerance to multiple ARV regimens. Patients must be three-class experienced, having received treatment from each of the three major oral classes of anti-HIV drugs (NRTIs, NNRTIs and PIs), unable to use currently approved NNRTIs due to resistance and/or intolerance and have received at least two PI-based regimens.

Pending U.S. regulatory approval, Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., will commercialize the product in the U.S. The trade name for the marketed product has not yet been determined.

About Tibotec Therapeutics

Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.

About Tibotec Pharmaceuticals Ltd.

Tibotec Pharmaceuticals Ltd., 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.

Ortho Biotech Products, L.P. and Tibotec Pharmaceuticals Ltd. 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 the Company'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, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at, or on request from the Company. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.

Media Contact: Pamela Van Houten

Office: 908-541-4137

Mobile: 908-295-7367

Investor Contacts: Louise Mehrotra (732) 524-6491

Stan Panasewicz (732) 524-2524

Lesley Fishman (732) 524-3922

SOURCE Tibotec Pharmaceuticals Ltd.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Mexico Supreme Court Accepts Petition To Review Mexico City Law Legalizing Abortion During First Three Months Gestation
2. Novartis files application with FDA for Zometa
3. Morepan to file new drug applications with the USFDA
4. Mini motor for micromedical applications
5. Perfusion bioreactor could enhance stem cell research and application in the future
6. Prostate Cancer Can Be Treated By Application Of LASER Technology
7. Varied Applications of Adult Stem Cells to Treat Host of Disorders in Human
8. Venus Remedies Files 5th International Patent Application
9. NICE supports application of advanced biological therapies as treatment option for acute psoriasis
10. Roche puts in an Application to Use Herceptin for Treatment in Her-2 positive breast cancer
11. New Drug Application Submitted for Investigational Antibiotic Doripenem
Post Your Comments:
(Date:11/30/2015)... ... ... While powdered supplements and drinks can reduce food preparation time, locating the ... has found an easy to keep track of the scoop. , He developed a ... a canister or other container handy and readily accessible. As such, it prevents the ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... announced at the Radiology Society of North America (RSNA) annual meeting, being held ... 60% growth from 2014. Throughout 2015, the company has completed installations for ...
(Date:11/30/2015)... ... November 30, 2015 , ... Volpara Solutions ... density assessment and enterprise analytics solutions, here at the 101st Annual Radiological ... booth #2377). Volpara’s quantitative breast imaging tools enable personalized measurements of volumetric ...
(Date:11/30/2015)... ... ... It’s inevitable that everyone will experience death in his or her lifetime. Whether ... among us. It is your perspective, however, that determines how you view death in ... Sky understands that she may see death more frequently than most. As she was ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... the speakers for “Value-Based Payer-Provider Partnerships: Three Case Studies,” an upcoming Dec. ... care arrangements: Essentia Health and UCare, MissionPoint Health Partners, and Intel Corp. ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... Nov. 30, 2015  Novartis will demonstrate the strength ... th American Society of Hematology (ASH) Annual Meeting. ... as well as supportive care, including key findings in ... cell therapies. The ASH Annual Meeting will be held ... Novartis Oncology . "We will be presenting ...
(Date:11/30/2015)... BOSTON , November 30, 2015 ... medicines directed at up to 10 G protein-coupled receptor ... PFE ) to research and develop potential new medicines ... targets across multiple therapeutic areas. --> Heptares ... development company and wholly-owned subsidiary of Sosei Group Corporation ...
(Date:11/30/2015)... TEL AVIV, Israel , November 30, 2015 /PRNewswire/ ... EMITF ) ("Elbit" or the "Company") announced today that it ... Ministry of Food and Drug Safety (MFDS) has approved ... behavioral disorders. --> --> ... presenting a non-invasive treatment alternative that combines two technologies: ...
Breaking Medicine Technology: