Date: 2012-08-09
Type of information: R&D agreement
Compound: Unyvero™ pneumonia molecular diagnostic system
Company: Curetis (Germany) Cempra Pharmaceuticals (USA)
Therapeutic area: Infectious diseases
Type agreement: R&D
Action mechanism: The CE-marked Unyvero™ System is a versatile hardware platform for the detection of a broad panel of bacteria and antibiotic resistances from a single sample in one run. It processes a disposable cartridge providing the necessary reagents to complete the analysis from sample to result. The platform enables the DNA-based testing of all clinically relevant samples in a fully automated, unsupervised analysis process requiring only few, quick manual preparation steps. The analysis can be performed with minimal operator time and without the need of skilled staff or special infrastructure. As a result, clinically relevant information is available within about four hours to support an informed therapy decision as early as possible. The first CE-marked Unyvero™ Cartridge, Unyvero™ P50, focuses on pneumonia testing and simultaneously analyze 39 DNA targets. Cartridges for further applications, for surgical site infections, blood stream infections and tuberculosis, are in preparation.
Disease: community-acquired bacterial pneumonia
Details: * On August 9, 2012, Curetis and Cempra have announced a research and development collaboration to incorporate Curetis\' Unyvero pneumonia molecular diagnostic system into Cempra\'s upcoming global Phase 3 trial of the oral formulation of solithromycin, in patients with community-acquired bacterial pneumonia (CABP).
Under the terms of the agreement, each party may use the generated data for its own product development and for its regulatory filings.
Cempra\'s randomized, double-blind Phase 3 trial comparing solithromycin against a compar-ator drug, is expected enroll about 800 patients in more than 100 clinical sites worldwide. Sputum samples from patients will be sent to Curetis for analysis with its Unyvero™ Solution and the CE-marked Unyvero™ P50 Pneumonia Application Cartridge. Molecular diagnostic data generated from the Unyvero Solution will be paired with clinical and traditional microbi-ology data to enhance the pathogen diagnosis rate in the trial. The trial is expected to start during the fourth quarter of 2012 and enrollment is expected to be completed in 2014.
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