Advanced Magnetics files NDA for Feridex

MRI contrast agent developerAdvanced Magnetics submitted a new drug application (NDA) lastmonth with the Food and Drug Administration for Feridex, an agentfor the detection of primary and metastatic liver tumors. Theaction follows the filing in November of an NDA for another AdvancedMagnetics agent, Gastromark (SCAN 12/29/93).

Advanced Magnetics, of Cambridge, MA, last year ironed outits marketing strategy for Feridex. Kodak subsidiary SterlingWinthrop has marketing rights for Feridex in North America andAustralia (SCAN 10/6/93). In Europe Feridex has been licensedto Guerbet of France, which filed for marketing approvals forthe agent last June under the trade name Endorem. Eiken Chemical,the product's Japanese licensee, is preparing to file an applicationthis spring in that country.

The U.S. contrast company estimates the global market for liveragents at about $300 million. Feridex can detect tumors as smallas 3 mm, compared to 1 cm for CT, according to the company.

Advanced Magnetics also reported last week that it has receiveda $2 million license fee from Squibb Diagnostics as a milestonepayment in its licensing agreement related to the MRI contrastagent BMS 180549. This agent is in phase II clinical trials atthe FDA for imaging of the lymph nodes. Assessment of lymph nodestatus could aid in staging primary cancers, such as breast orcolon cancer, which metastasize through the lymphatic system,Advanced Magnetics said.