Date: 2012-02-07
Type of information: Development agreement
Compound: companion diagnostic for Celsentri/Selzentry® (maraviroc)
Company: Siemens Healthcare Diagnostics (USA), subsidiary of Siemens AG (Germany) ViiV Healthcare (USA)
Therapeutic area: Infectious diseases
Type agreement: R&D, development, commercialisation
Action mechanism:
Disease: HIV-Aids
Details: Siemens Healthcare Diagnostics continues to strengthen its positions in the areas of personalized medicine and companion diagnostics. Complementing its move into next-generation sequencing, the company has just established two new partnerships with pharmaceutical companies to offer clinical trial expertise as well as diagnostic test development and commercialization. A new companion diagnostics partnership has been concluded with ViiV Healthcare. This partnership will focus on clinical trials related to Celsentri/Selzentry® (maraviroc) — ViiV Healthcare\'s novel CCR5 co-receptor antagonist for the treatment of CCR5-tropic HIV — followed by potential commercialization of a diagnostics test to assist in patient selection prior to physician treatment decisions, subject to FDA approval. ViiV Healthcare previously announced the start of the Phase III MODERN Study [Maraviroc Once daily with Darunavir Enhanced by Ritonavir in a Novel regimen], also known as A4001095, comparing its CCR5-inhibitor, Celsentri/Selzentry® (maraviroc), to emtricitabine/tenofovir (Truvada®), both in combination with darunavir/ritonavir. The 96-week trial will evaluate a two-drug versus three-drug once-daily regimen for the treatment of antiretroviral-naive patients infected with CCR5-tropic HIV-1. In addition, MODERN is the first large Phase III trial that will compare the performance of a genotypic test with a phenotypic test in identifying patients appropriate for use of Celsentri/Selzentry®. Patients will be randomised to undergo screening with either the genotypic or phenotypic test. Genotypic tropism testing in the MODERN study is provided by Siemens Healthcare Diagnostics as part of this partnership and phenotypic testing (Trofile®) by Monogram Biosciences. Subject to FDA approval, Siemens Healthcare Diagnostics may commercialize their genotypic tropism diagnostic test. The other partnership has been conclued with Tocagen.
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