Vancouver - Migenix Inc. says that its partner for the development and commercialization of MX-226 in North America and Europe, Cadence Pharmaceuticals, Inc., and the FDA have reached written agreement on a protocol for a Phase III clinical trial of MX-226, which, if successful, would support the approval of MX-226 for the prevention of catheter-related infections.
This agreement was reached under the PDA's special protocol assessment (SPA) process. In July 2004, Cadence licensed certain rights to MX-226 (known as CPI-226 at Cadence) from Migenix for the North American and European markets in a deal totalling US$32 million before a double-digit royalty on net sales. Cadence is preparing to initiate the second pivotal Phase III study of MX-226 in the third quarter of 2005 pursuant to the SPA.
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