WASHINGTON—Dialysis provider Fresenius Medical Care and Luitpold have closed a deal under which Fresenius will obtain exclusive rights to manufacture, supply and distribute the IV iron drug Venofer to the U.S. end-stage renal disease population.
In July, 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. Fresenius also signed a sublicense for a new iron drug called Injectafer.
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.
Under the deal, which was approved by the U.S. Federal Trade Commission under the Hart-Scott-Rodino Act, Luitpold will continue selling Venofer for use in kidney disease patients not on dialysis and acute renal failure patients in hospitals, according to Fresenius. In addition, Luitpold will continue paying royalties to Swiss-based Vifor Pharma, which supplies the active pharmaceutical ingredient for the drugs.
“We are extremely pleased with the FTC’s decision and with the successful launch of our new licensing relationship with Fresenius Medical Care,” Mary Jane Helenek, president and CEO of Luitpold, said in a statement. “The new license agreement reflects our long-term strategy for IV iron, including Venofer. It allows American Regent to focus on developing Venofer and future IV iron products in new applications, including non-dialysis CKD.”
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.
“We are pleased to be able to complete this agreement which strengthens our ability to improve the treatment of iron deficiency anemia experienced by dialysis patients,” Ben Lipps, CEO Fresenius Medical Care, said in a statement. “We are delighted to have Galencia Ltd., Vifor Pharma, Luitpold Pharmaceuticals Inc. and American Regent Inc., as partners. The license to make and distribute these products is an important milestone in the execution of Fresenius Medical Care’s renal pharma strategy.”
