BAD HOMBURG, Germany--(BUSINESS WIRE)--Fresenius Medical Care AG & Co. KGaA, the world’s largest provider of dialysis products and services, today announced that it signed exclusive license agreements for the intravenous (IV) Iron products Venofer® (iron sucrose) and Ferinject® (ferric carboxymaltose) to treat iron deficiency anemia experienced by dialysis patients. Venofer® is the leading IV Iron product worldwide.
Galenica Ltd., its subsidiary Vifor Pharma and Fresenius Medical Care are entering into a strategic joint venture for dialysis to market and distribute the two iron products Venofer® and Ferinject® in Europe, Middle East, Africa and Latin America. The agreement concerns all commercialization activities for these IV Iron products in the field of dialysis and is expected to become effective not later than January 1st, 2009.
Commercialization of these respective IV Iron products outside the field of dialysis will remain fully the responsibility of Vifor Pharma and its existing key partners.
The total market for IV Iron in Europe, Middle East, Africa and Latin America was greater than $120 million in 2007. After the first year of the agreement, Fresenius Medical Care expects yearly sales from both IV Iron products to be in excess of $50 million.
In North America, a second Agreement provides for an exclusive U.S. manufacturing and distribution sublicense for Venofer® with Luitpold Pharmaceuticals Inc (Luitpold). In addition, it includes a similar sublicense for the next generation of iron products for the U.S. and Canada known as Injectafer® (ferric carboxymaltose) injection, which is expected to enhance the treatment of anemia in the dialysis patient population through the application of innovative drug administration techniques. The transaction is subject to customary closing conditions including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Act. The closing of the transaction is anticipated in 2008.
Luitpold will continue to sell Venofer® for use in treating chronic kidney disease patients not yet on dialysis and in treating patients with acute renal failure in hospitals. Venofer® is currently the market leader in sales in the injectable iron market in the U.S. Currently, the total purchases of IV Iron in the U.S. are approximately US$ 500 million. Venofer® has a U.S. market share of approximately 55%. Galenica Ltd., through its Vifor Pharma subsidiary, exclusively licenses the Venofer® and Injectafer® products to Luitpold and American Regent for the U.S. and Canada.
As part of the 10-year Agreement for North America, Luitpold will continue to contract manufacture the products for Fresenius Medical Care. Luitpold will continue to pay royalties to Vifor Pharma, based in St. Gallen, Switzerland, which supplies the active pharmaceutical ingredient to Luitpold.
Ben Lipps, Chief Executive Officer of Fresenius Medical Care, commented: “We are very pleased to have Galenica 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. It is an excellent opportunity for us to access a proven and effective IV Iron product portfolio. With these agreements we will also deploy our “Pharmatech” strategy, aimed to introduce new drug delivery systems to improve quality and safety of dialysis treatments.”
Fresenius Medical Care is the world’s largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 1,600,000 individuals worldwide. Through its network of 2,297 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 177,059 patients around the globe. Fresenius Medical Care is also the world’s leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME, FME3) and the New York Stock Exchange (FMS, FMS/P). For more information about Fresenius Medical Care visit the Company’s website at www.fmc-ag.com.
Galenica is a diversified group active throughout the healthcare market which, among other things, develops, manufactures and commercialises pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. The Galenica Group enjoys a leading position in all its business sectors – Pharma, Logistics, HealthCare Information and Retail. A large part of the Group’s income is generated by international operations. Additional information on the Galenica Group can be found at www.galenica.com.
Luitpold Pharmaceuticals, Inc., headquartered in Shirley, NY, manufactures and distributes over 65 pharmaceutical products including Venofer® (iron sucrose injection, USP), the leading IV iron therapy in the U.S., through its human health subsidiary, American Regent, Inc. Luitpold Pharmaceuticals, Inc., a Daiichi-Sankyo Group company, also markets dental bone regeneration products and veterinary pharmaceuticals through its Osteohealth and Animal Health divisions. Daiichi Sankyo Company, Ltd., established in 2005 after the merger of two leading century-old Japanese pharmaceutical companies, is a global pharmaceutical innovator, continuously generating innovative drugs that enrich the quality of life for patients around the world. For more information about Luitpold see www.luitpold.com.
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA’s reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.
Contact:
Fresenius Medical Care AG & Co. KGaA Investor Relations: Oliver Maier, + 49 6172 609 2601 Fax: + 49 6172 609 2301 ir@fmc-ag.com or North America: Terry L. Morris, + 1-800-948-2538 Fax: + 1-615-345-5605 ir@fmc-ag.com www.fmc-ag.com
Source: Fresenius Medical Care
