HIV :: Tibotec submits marketing authorisation application for investigational HIV treatment TMC125 in Europe

Tibotec Pharmaceuticals Ltd. announced 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 18 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.

TMC125 is the first NNRTI to show significant antiviral activity in patients with documented NNRTI resistance. The TMC125 dose studied in DUET-1 and DUET-2 was 200mg twice daily.

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.

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