MRI agents jockey for market position (pending)

With Food and Drug Administration approval pending for two newMRI contrast agents, manufacturers are jockeying for legal footholdsin this potentially explosive market.

Bristol-Myers Squibb (BMS) has already swapped marketing rightswith Schering AG to clear the way for Prohance, an experimentalnonionic gadolinium-based agent. Schering holds patents on gadolinium-basedimage enhancement technology.

Under the terms of the Squibb-Schering deal, Schering receivesU.S. marketing rights to Squibb's antiarrhythmic agent Betapace,said Janet Skidmore, BMS director of international public affairs.BMS receives worldwide rights under Schering's existing patentsand patent applications relating to gadolinium-based Prohance.

The drug received a favorable review by FDA commissioners lastNovember and BMS predicts FDA approval by the end of the year.

"We're very optimistic that we'll see approval of Prohancein 1992. But the FDA operates in its own time frame, so we don'tknow exactly when the word will come down," Skidmore said.

Also racing to the FDA finish line is Omniscan, another nonionicgadolinium agent, manufactured by Nycomed and licensed by SterlingWinthrop.

A Schering AG representative has discounted rumors that theGerman pharmaceutical company filed a patent infringement suitagainst Nycomed and Sterling Winthrop over Omniscan (SCAN 5/20/92).Schering holds patents on gadolinium-based image enhancement technology.

"Schering has not filed any such suit for patent infringementagainst Nycomed," said Wendy Neininger, Schering's pressliaison in New York. "The rumor is unfounded."