| |
Tibotec Submits Marketing Authorisation Application for Investigational HIV Treatment TMC125 in Europe
|
| |
| |
Phase III Data on TMC125, Next-Generation NNRTI, Recently Presented at IAS 2007
Mechelen, BELGIUM, July26 - Tibotec Pharmaceuticals Ltd. announced today that it has submitted an application for marketing authorisation for TMC125 to the European Agency for the Evaluation of Medicinal Products (EMEA). TMC125 is an investigational next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for use with other antiretroviral agents for the treatment of HIV-1 infected patients, including those with NNRTI resistance. This submission was completed one week after the submission of a New Drug Application for TMC125 to the United States Food and Drug Administration, which the company announced on 25 July 2007.
Both submissions are based on the efficacy and safety results of two pivotal Phase III randomised, placebo-controlled studies, known as DUET-1 and DUET-2 (TMC125-C206 and TMC125-C216), which examined the use of TMC125 in combination with an optimised background regimen in treatment-experienced HIV-1 patients with documented resistance to NNRTIs. Data from these studies were published in the 7 July 2007 issue of The Lancet and presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2007), in Sydney, Australia, on 25 July 2007.
Pending regulatory approval, Tibotec, a division of Janssen-Cilag, will commercialize the product in Europe and other countries, and Tibotec Therapeutics will commercialize the product in the U.S. The trade name for the marketed product has not yet been determined.
TMC125 Expanded Access Program
The expanded access program (EAP) for TMC125 is now open in a number of European countries, Canada and the United States. TMC125 is available 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.
For more about the program, healthcare professionals and people living with HIV/AIDS may obtain information by visiting www.clinicaltrials.gov.
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.
Tibotec Pharmaceuticals is developing a Global Access Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries.
About Tibotec
Tibotec, a division of Janssen-Cilag, brings 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 health care providers' specific needs in this disease domain. The company will also commercialise medicine against other viral diseases in the future.
|
|
| |
| |
|
|
|
