Fresenius Medical Care and Toray reach European license agreement on antipruritic TRK-820

April 04, 2012


Fresenius Medical Care AG & Co. KGaA (“the company”; Frankfurt Stock Exchange: FME / New York Stock Exchange: FMS), the world’s largest provider of dialysis products and services, today announced the signing of an agreement with Toray Industries, Inc regarding exclusive development and marketing in Europe of an injectable form of TRK-820 (Toray development code; generic name: nalfurafine hydrochloride), an innovative antipruritic agent originated and developed by Toray. Under this agreement, Fresenius Medical Care will exclusively market the product in Europe once Toray receives approval for TRK-820 in the region.

TRK-820 is a highly selective κ (kappa) opioid receptor agonist. It was launched in Japan in March 2009 as a treatment for hemodialysis-related uremic pruritus under the brand name REMITCH® CAPSULES 2.5μg (manufactured by and marketing approval held by Toray; distributed by Torii Pharmaceutical Co., Ltd.; in alliance with Japan Tobacco Inc.). In Europe, Toray has been developing the drug as an injection instead of the oral form, so that it can be administered at a dialysis center after receiving dialysis.

Pruritus experienced by hemodialysis patients is non-inflammatory but generalized and severe although it is not so frequent. Some patients suffer from lack of sleep due to severe itching, which worsens their quality of life (QOL). In addition, scratching due to severe itching results in skin inflammation and infections which aggravate systemic symptoms. It is well known that conventional antipruritic agents including antihistamines cannot fully suppress this itching. Against this background, the injectable form of TRK-820 has been designated as an orphan drug by the European Medicines Agency (EMA) for treating pruritus experienced by hemodialysis patients.

The agreement announced is a result of Toray’s search for a strong sales network in the European dialysis-related pharmaceutical field. It also falls in line with Fresenius Medical Care’s strategic objective to enhance its pharmaceutical product lineup for dialysis patients. The two companies will work together on preparing the Marketing Authorization Application for submission to the EMA this year, in order to obtain marketing approval and introduce the product to the market as soon as possible.

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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 2.1 million individuals worldwide. Through its network of 2,898 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 233,156 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.

Toray Group is an integrated chemical group developing its business in 23 countries and regions worldwide. Toray Group fuses nanotechnology into its operations, using organic synthetic chemistry, polymer chemistry and biotechnology as its core technologies. In addition to the Foundation Businesses of fibers & textiles and plastics & chemicals, Toray likewise promotes the global development of IT-related products, carbon fiber composite materials, pharmaceuticals and medical products, environment & engineering including water treatment and progress in other pivotal business fields.

For more information about Toray, visit the Company’s website at www.toray.com.

Disclaimer
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.
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