Shire, Sanofi-Aventis and Firazyr CRA consultants advised counsel to Shire Orphan Therapies, LLC (Shire) and Sanofi-Aventis Deutschland GMBH (Sanofi-Aventis) in their challenge of an ANDA filed by Fresenius Kabi USA, LLC (Fresenius). Fresenius sought to manufacture and sell a generic version of Firazyr, ® an antiinflammatory drug to treat hereditary angioedema (HAE). Dr. Bell testified for the plaintiffs as to the commercial success of Firazyr. The US District Court for the District of Delaware decision noted Firazyr outperformed other HAE treatments as it is the only acute treatment that can be administered subcutaneously. The Court also found the defendants had failed to establish that Firazyr’s commercial success is due to factors other than those enabled by the patents-in-suit. Dr. Bell was supported by a team that included Dr. Andrew Tepperman and Archan Ruparel.
MFN is rewriting the launch planning playbook: Commercial and market access strategies must integrate to succeed
MFN-related uncertainty is reshaping pharmaceutical launch planning by making pricing, sequencing, and forecasting decisions more interconnected and...