Gadoxate disodium: gadolinium EOB DTPA, gadoxetic acid, Gd-EOB-DTPA

Abstract

Gadoxate disodium [gadolinium EOB DTPA, Gd-EOB-DTPA, gadoxetic acid, Eovist injection, Primovist] is a hydrophilic paramagnetic contrast agent being developed by Schering AG for hepatobiliary magnetic resonance imaging. In April 2004, gadoxate disodium (Primovist) was approved in Sweden, the reference member state for the EU registration. Following the Swedish approval, Schering will initiate a mutual recognition procedure for the EU with approvals expected in most countries during 2004. Gadoxate disodium is in phase III clinical trials in the US and has completed phase III studies in Japan. Submissions for approval in Japan and other Asian countries are planned for 2004. Schering AG plans to launch Eovist in Japan in 2005. Schering AG acquired a worldwide, royalty-bearing licence to EPIX Medical's patents covering liver-enhancing agents such as Eovist injection. These included a European patent (222886) and the US patents (4,899,755 and 4,888,008) that EPIX Medical exclusively licensed from the Massachusetts General Hospital (MGH). The MGH patents, a part of EPIX's extensive intellectual property, also covered albumin-targeted agents such as MS 325 (AngioMARK). Schering AG formally withdrew from the opposition proceedings against EPIX's EU patent 222886 following its acquisition of EPIX's intellectual property. These EU and US patents were also non-exclusively licensed by EPIX Medical to Bracco in September 2001. Apart from covering Eovist (Schering AG), the EU patent also covered gadobenate dimeglumine (MultiHance Bracco). Following the licensing agreement, Bracco withdrew its opposition to the patents in Europe and Japan, and both EPIX Medical and Bracco settled their European patent dispute. In its 2002 Annual Report, Schering predicted that Eovist has the potential to reach peak sales of euro50 million, three years after launch--at the time, launch in Europe was anticipated in 2004, followed by launch in Japan in 2005. This is down from earlier predictions, made at an analyst presentation in Berlin in March 2002, when the company forecast the product to reach peak sales of euro100 million.