Nycomed mum on plans to sell generic x-ray contrast agents

Company signs deal with Fujisawa for U.S. rights

Norwegian contrast agent developer Nycomed has acquired U.S. rights to market a generic version of the x-ray contrast agent iopamidol, but the Oslo company isn't saying much about its intentions in the generic field. If Nycomed does follow through, it could shake up the contrast industry by selling a generic version of a product that is marketed in branded form by itself and its competitors.

Nycomed last month reported that it signed a deal with Fujisawa USA of Deerfield, IL, for rights to market iopamidol in the U.S. Iopamidol is the generic name for Bracco's Isovue nonionic, low-osmolar contrast medium (LOCM), which went off patent last year. Bracco has been trying to extend the patent, although its chances of success are slim (SCAN 3/5/97).

Fujisawa's version of iopamidol was declared bioequivalent to the branded version by the Food and Drug Administration, and the company received clearance in April to market iopamidol in 51%, 61%, and 76% concentrations.

Most contrast industry analysts have portrayed the expiration of iopamidol's patent as a threat to established contrast firms like Nycomed, Bracco, and Schering, as it enables new competitors into the market with generic products that will likely lead to price erosion for branded agents. Indeed, a number of pharmaceutical companies are preparing generic versions of iopamidol, including Abbott Laboratories of Abbott Park, IL, Hovione of Portugal, Faulding Pharmaceutical of Elizabeth, NJ, and ESI-Lederle, a division of American Home Products.

Few observers have expected one of the established contrast firms to introduce generic iopamidol, however. In Nycomed's case, the generic LOCM product it has accessed from Fujisawa may wind up competing with its own Omnipaque (iohexol) nonionic x-ray contrast agent. Omnipaque held 46% of the U.S. nonionic market in 1995 (SCAN Special Report 5/96).

Nycomed declined to comment extensively on its plans to sell generic iopamidol, other than to say that its agreement with Fujisawa is consistent with the company's commitment to meeting the needs of its customers. A spokesperson did say, however, that the company expects minimal cannibalization because Omnipaque has a broader range of indications and packaging options.

In other Nycomed news, the company has received European marketing approval to sell its Teslascan liver-specific MRI contrast agent. The approval is valid for all countries in the European Union, Nycomed said. Teslascan has received an approvable letter from the FDA (SCAN 5/28/97).

Nycomed also signed a deal with Debiotech of Switzerland for North American sales of an advanced contrast media delivery system for CT and other intravenous procedures. Nycomed bought worldwide rights to the system, except in Japan, and expects to begin deliveries of the product in the first half of 1998.