Roche
This article was originally published in The Gray Sheet
Executive Summary
Firm plans to submit separate biologics license applications (BLAs) to FDA in 2001 for its Cobas Ampliscreen HCV and HIV nucleic acid amplification (NAT) tests for screening of blood intended for transfusion. Roche is negotiating with Chiron to expand a related temporary patent license that expires at the end of 2001 under an October agreement (1"The Gray Sheet" Oct. 16, 2000, p. 7). Failure to secure a longer term agreement would leave Chiron as the sole supplier of such tests once it receives approval; clinical trials are ongoing. Diagnostic and monitoring tests, such as Roche's Amplicor Version 2.0 and Cobas Amplicor automated Version 2.0 HCV tests, which are pending FDA approval, are not related to the temporary license
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