Ferrlecit appro a fillip for Schein after INFeD woes

Schein Pharmaceuticals has been granted approval in the USA to marketFerrlecit (sodium ferric gluconate complex), an injectable iron replacement therapy for iron deficiency in patients undergoing hemodialysis and erythropoietin treatment. Schein already markets INFeD (iron dextran) as an injectable iron replacement product, but has been hit recently by difficulties in adhering to manufacturing regulations for the product.

Ferrlecit will reach the market in the mid to late second quarter. It is manufactured by Rhone-Poulenc Rorer in the UK, and is marketed worldwide by R-PR GmbH of Germany. Schein has exclusive rights to the product in the USA and certain other countries (eg Canada, the UK, Japan), and has not ruled out a marketing partnership with minority stakeholder Bayer, which already earns a cut of INFeD sales. Sales of INFeD are currently running at around $100 million a year, despite the manufacturing problems, and represented around 85% of the injectable iron market in 1997.

Ferrlecit has advantages over INFeD in terms of lower dosing and the fact that it is not associated with anaphylaxis, which occurs rarely with the iron dextran product. However, Ferrlecit has been associated with side effects such as hypersensitivity, and the company has been instructed to conduct additional safety studies as a condition of approval. Schein maintains that it does not intend Ferrlecit to replace INFeD, as they will have different use-profiles. Ferrlecit will be sold at a premium to INFeD, noted the company.