Healthcare Industry News:  hemodialysis 

Devices Regulatory

 News Release - July 20, 2006

Fresenius Medical Care Receives Regulatory Approval for New Phosphate Binding Agent in Germany

BAD HOMBURG, Germany--(HSMN NewsFeed)--July 20, 2006--Fresenius Medical Care ("the Company"), the world's largest provider of Dialysis Products and Services, has received regulatory approval from Germany's Federal Institute for Drugs and Medical Devices (Bundesinstitut fur Arzneimittel und Medizinprodukte) for a new phosphate binding agent. The drug "OsvaRen" is expected to be introduced to the German market in the second half of 2006. The Company aims at quickly receiving accelerated approval for the new phosphate binding agent in other countries within the European Union using the mutual recognition process. The new phosphate binding agent should be introduced in all European Countries in 2007.

The newly approved product is a phosphate binding agent that is made from a combination of calcium acetate and magnesium carbonate. Excess phosphate consumed with food is normally removed by the kidneys in a process that can only partially be replaced by dialysis in patients with chronic kidney failure. Too much phosphate in the blood can result in mid-term damages to bones and blood vessels. The risk of such damages can be lowered by regularly taking in phosphate binders. The new compound from Fresenius Medical Care combines two substances known to support bone health while optimizing the levels of calcium.

With the approval of the new drug Fresenius Medical Care has made a further step to develop new business opportunities with new renal therapy options combining dialysis expertise in products and services with certain drugs commonly used in dialysis.

"The expansion of our business into the renal drug arena for the treatment of patients with chronic kidney failure is part of our horizontal diversification. By further strengthening our broad portfolio of dialysis-related products and therapies, we create the basics for sustainable and profitable growth of our Company. This is a very interesting step where we are now able to partially address such opportunities in the market place" said Dr. Emanuele Gatti, Fresenius Medical Care Management Board Member responsible for Europe, Latin America, the Middle East and Africa.

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 1,400,000 individuals worldwide. Through its network of approximately 2,045 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to approximately 158,700 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.

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.


Source: Fresenius

Issuer of this News Release is solely responsible for its content.
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