Fresenius signs deal to market IV iron drugs

BAD HOMBURG, Germany—Fresenius Medical Care said today that it has signed an exclusive licensing agreement for the intravenous iron products Venofer and Injectafer to treat iron deficiency anemia in dialysis patients.

The deal adds to Fresenius’ exclusive use of certain drugs used in dialysis patients. In 2006, the company signed a five-year agreement with Amgen to use the anemia drugs Epogen and Aranesp. In that same year, Fresenius bought the phosphate binder PhosLo from Nabi Pharmaceuticals for $150 million.

In addition, Fresenius Medical Care’s parent company Fresenius SE announced July 7 that it is buying APP Pharmaceuticals for $3.7 billion. APP has more than 100 products, including the blood-thinning drug heparin, which is used frequently in dialysis treatments.       

The iron deal Fresenius announced today includes two agreements: one for North America and another for Europe, the Middle East, African and Latin America, according to Fresenius.

In North America, Fresenius signed an exclusive 10-year U.S. manufacturing and distribution sublicense for Venofer with Luitpold Pharmaceuticals, which makes and sells the iron drug through its subsidiary American Regent.

The IV drug market is lucrative in the United States with sales reaching approximately $500 million, according to Fresenius. Venofer’s U.S. market share is approximately 55 percent.

In addition, Fresenius has a sublicense for a new iron drug called Injectafer, which Fresenius said will “enhance the treatment of anemia in the dialysis patient population through the application of innovative drug administration techniques.”

The North American deals are expected to close in 2008.

Luitpold will continue selling Venofer for use in kidney disease patients not on dialysis and acute renal failure patients in hospitals, according to Fresenius. Under the deal, Luitpold will also continue to manufacture the products for Fresenius. In addition, Luitpold will continue paying royalties to Swiss-based Vifor Pharma, which supplies the active pharmaceutical ingredient for the drugs.

Outside of the United States, Fresenius signed a deal with Vifor and its parent company Galencia to market and distribute Venofer and Ferinject (the name of Injectafer outside the United States) in Europe, the Middle East, Africa and Latin America for use in dialysis. The deal is expected to be start no later than Jan. 1, 2009. Under the deal, Vifor will keep the job of commercializing the iron products for use outside of dialysis.

Fresenius said the market for IV drugs in these markets was more than $120 million in 2007, and it expected annual sales from both drugs to exceed $50 million.

“We are very pleased to have Galencia Ltd., Vifor Pharma, Luitpold Pharmaceuticals Inc, and American Regent Inc. as our partners dedicated to improving the treatment of iron deficiency anemia experienced by dialysis patients,” Ben Lipps, CEO of Fresenius Medical Care, said in a statement. “It is an excellent opportunity for us to access a proven and effective IV iron product portfolio.”