Advanced Magnetics gains FDA clearance for MRI contract agent targeted at liver

Approval of Feridex IV follows 11-year research effort

Advanced Magnetics' 11-year effort to develop the first liver-specificMRI contrast agent culminated last week with Food and Drug Administrationapproval of Feridex IV.

The intravenous imaging agent was approved for use in adultsto detect and evaluate liver lesions, according to Mark Roessel,vice president of regulatory affairs at the Cambridge, MA, company.Clinical trials demonstrated that Feridex improves the delineationof liver lesion margins and uncovers lesions obscured in unenhancedstudies, he said.

It is difficult to predict the market potential for Feridex, saidCEO Jerome Goldstein in a July interview with SCAN.

"It may have value in situations where the physician isinterested in liver segment involvement in terms of metastaticdisease or detecting smaller or additional lesions," Goldsteinsaid. "About 1.5 million of those scans are performed annually."

FDA approval triggered a $5 million milestone payment fromBerlex, the company's marketing partner for Feridex in the U.S.and Canada. Sales will begin in the next few months, Goldsteinsaid.

The FDA's action improves Feridex's prospects for regulatoryclearance in Japan, where Koshaysho, the Japanese Health Ministry,will soon rule on the agent, Roessel said. Goldstein learned aboutFeridex's U.S. clearance while he was in Japan for the ribbon-cuttingof a $35 million factory to manufacture Feridex sold in Japan.The facility was built by Eiken Chemical Company of Tokyo, whichholds Japanese manufacturing and distribution rights for the agent.

Guerbet of Aulnay, France, has sold Feridex in Europe under theEndorem trade name for several years. Advanced Magnetics latelast month announced a deal with TaeJoon Pharmaceutical of SouthKorea for Feridex sales in that country.

Feridex follows Magnevist, Omniscan, ProHance, and Imagent GIas the fifth MRI contrast agent to enter the $120 million U.S.MRI contrast market. It is the first MRI agent since August 1993to gain FDA approval.

The agent made several breakthroughs to gain that distinction.Unlike the current crop of nonspecific, gadolinium-based agents,like Magnevist, Feridex IV is the first superparamagnetic ferriteparticle to earn FDA approbation.

The agent's status as the first in its class contributed to numerousregulatory delays, Roessel said. The FDA issued an approvableletter for Feridex in February, some 24 months after AdvancedMagnetics filed a new drug application for the agent. Subsequentdelays arose from disagreements between the company and federalofficials over the package insert language, Roessel said.

"In discussing labeling, we were concerned that iron oxidesas a class received appropriate labeling," he said.

Gastromark, a MRI bowel marker developed by Advanced Magnetics,has also faced a time-consuming regulatory review, Goldstein said.An NDA for that product was filed in November 1993, and an approvableletter was issued in May 1996. Final clearance is pending.

Goldstein reported in July that the extended regulatory reviewof the two agents was costing Advanced Magnetics $50,000 a day.The company was not in any financial jeopardy, however, he said.In its most recent quarterly report, Advanced Magnetics reportedcurrent assets of $37.3 million, with cash and cash equivalentsconstituting $12.3 million of that total.