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Galenica and Fresenius Medical Care enter into a strategic joint-venture
Galenica Ltd., through its subsidiary Vifor Pharma and Fresenius Medical Care AG & Co. KGaA, the world's largest provider of dialysis products and services, have entered into an exclusive license agreements for Vifor Pharma's intravenous i.v. iron products Venofer® (iron sucrose) and Ferinject® (iron carboxymaltose) to treat iron deficiency anaemia experienced by dialysis patients. Venofer® is the leading i.v. iron product worldwide and accepted as gold standard in dialysis.
This agreement will allow Galenica to consolidate its leading position in the global dialysis market. The measure will also enable Galenica to devote all of its scientific, medical and commercial capacities, which have already been significantly strengthened through the acquisition of Aspreva, to indications outside the field of dialysis (gastroenterology, gynaecology, oncology, cardiology and non-dialyses chronic kidney disease). Sales outside the field of dialysis already represent almost 90% of the Swiss market for Ferinject® and Venofer®.
Joint marketing, distribution and development of i.v. iron products exclusively in the field of dialysis for Europe, Middle East, Africa and Latin America
The strategic joint-venture includes the distribution of the two i.v. iron products Venofer® and Ferinject® in Europe, Middle East,Africa and Latin America exclusively in the field of dialysis. The agreement concerns all commercialisation activities for these i.v. iron products in the field of dialysis and is planned to come into effect not later than January 1st, 2009. Through FMC's expertise and market position it is anticipated they will be able to strengthen and build upon the leading market share of Venofer® and Ferinject® in this key market segment. The agreement is an excellent opportunity for Fresenius Medical Care to access a proven and effective i.v. iron product portfolio. Commercialisation of the respective i.v. iron products outside the field of dialysis will remain fully the responsibility of Vifor Pharma and its affiliates as well as its existing key partners.
The total market for i.v. iron in Europe, Middle East, Africa and Latin America was in excess of USD 150 million in 2007.
Agreement between Luitpold Pharmaceuticals, Inc., the U.S licensing partner of Vifor Pharma, and Fresenius Medical Care for the markets in the United States and Canada Galenica Ltd. through its Vifor Pharma subsidiary exclusively licenses the Venofer® and Injectafer® products to Luitpold Pharmaceuticals, Inc. for the United States and Canada. For those markets, Fresenius Medical Care and Luitpold have entered into an agreement concerning an exclusive U.S. manufacturing and distribution sublicense for Venofer® in the field of dialysis. The transaction is subject to customary closing conditions including the 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 dialyses. Venofer® is currently the market leader in sales in the injectable iron market in the U.S. Currently, the i.v. iron market in North America for the dialysis applications exceeds USD 500 million.
As part of this 10 year agreement, Luitpold will continue to contract manufacture these products for Fresenius Medical Care. Luitpold will continue to pay royalties to Vifor Pharma in St. Gallen, Switzerland, which supplies the active pharmaceutical ingredient to Luitpold.
In addition the agreement between Luitpold and Fresenius Medical Care includes a similar sublicense for the next generation of i.v. iron products for the U.S. and Canada known as Injectafer® (US brand name for Ferinject®, ferric carboxymaltose), which is expected to enhance the treatment of anaemia in this same patient population, through the application of innovative drug administration techniques.
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. 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 Co., Ltd is a major Japanese Pharmaceutical company. Injectafer(TM) will be marketed under license from Vifor Pharma, a company of the Galenica Group.
For more information about Luitpold see www.luitpold.com.
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