Fresenius Medical Care and Toray reach European license agreement on antipruritic TRK-820
April 04, 2012
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.
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.
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.