Iron Replacement Roundup

In Corona, Calif., Watson Pharmaceuticals announced it would continue to sell its iron deficiency treatment, Ferrlecit, in the United States until the end of the year. A Swiss arbiter ruled in favor of Watson. In March 2008, Ferrlecit’s maker, Sanofi-Aventis, let Watson know that their joint agreement for supply and distribution of Ferrlecit would expire on Feb. 18, 2009, according to a filing with the U.S. Securities and Exchange Commission. Sanofi-Aventis noted it would expect damages if any sales occur after that date.

In a decision favoring Watson, the Swiss Chambers of Commerce Court of Arbitration ruled that the Ferrlecit supply and distribution agreement between Watson and Sanofi-Aventis would expire on Dec. 31. As a result, Watson officials announced the company would continue to market and sell Ferrlecit until year-end. Watson reports it is still in talks with Sanofi-Aventis in an effort to extend the agreement into 2010. If the two companies cannot agree by the Dec. 31 deadline, Watson must stop selling the drug.

According to a new report, “Global Intravenous (IV) Iron Drugs Market: Potential Opportunities,” Watson is second only to Galenica Limited in terms of IV iron drug market share. The report said that Venofer— from Galenica Limited—has emerged as the undisputed leader in the IV iron drugs market and has overtaken the market share of Watson’s Ferrlecit and InFed. The global market for IV iron drugs is growing, mainly in the hemodialysis setting, and IV iron could be used in many other therapeutic areas that are “highly under-penetrated,” according to the report. The chronic kidney disease (CKD) population is growing outside the United States, and pricing of such drugs is lower. The market in countries like China is still developing and “growing rapidly, with tremendous potential.”

Two new iron drugs are on the horizon. The U.S. Food and Drug Administration was expected to complete its review of AMAG Pharmaceuticals’ anemia drug Feraheme by June 29, the company announced. AMAG would like marketing approval for Feraheme (ferumoxytol injection), an iron replacement therapy to treat iron deficiency anemia in CKD patients.

In addition, the FDA accepted Lexington, Massachusetts–based AMAG’s resubmission of Feraheme’s New Drug Application. The FDA had requested more information last December.

Rockwell Medical Technologies (RMTI) is testing a water-soluble iron replacement therapy for dialysis patients called SFP (soluble ferric pyrophosphate). The firm recently completed enrollment for a Phase 2b study of SFP, which is a six-month, dose-ranging study. About 130 hemodialysis patients are participating as the company determines safety parameters and optimal SFP concentration to maintain normal levels of iron and hemoglobin. The Phase 2b trial should be available for release in late November or early December, after the clinical trial ends in September.