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Elaprase

Shire Pharmaceuticals Group PLC

Drug Names(s): I2S, iduronate-2-sulfatase, idursulfase

Description: Idursulfase is an enzyme replacement therapy that is under development for patients with Hunter Syndrome (MPS II). Hunter Syndrome is a genetic disease in which the affected individual has inadequate levels of the enzyme iduronate-2-sulfatase. This enzyme deficiency results in the accumulation of glycosaminoglycans (GAGs), specifically dermatan sulfate and heparin sulfate. Over time this buildup of GAGs can cause a thickening of the heart valves along the walls of the heart, which leads to a decline in cardiac function. The liver and spleen can also become enlarged in patients with this disease. Severe cases of Hunter Syndrome affect the central nervous system causing mental retardation.

Deal Structure: TKT and Genzyme
In September 2003, TKT and Genzyme announced that they had reached an agreement in which Genzyme would develop and commercialize I2S in Japan and other Asian/Pacific countries. TKT retains 100% of the marketing rights in all other areas of the world, including the U.S. and EU.Genzyme bears the responsibility for conducting a small clinical trial in Japan. This will be bridging study and is a requirement for approval in that market. Genzyme will make an upfront payment of $3 million to TKT and TKT has the potential to receive an additional $8 million in milestone payments. TKT will manufacture I2S and will receive approximately one third of the net sales in these territories.

Shire and Samaritan
In March 2007, Samaritan Pharmaceuticals executed a two-year exclusive licensing deal with Shire for the marketing of Elaprase in Greece and Cyprus. Elaprase will be sold and distributed by Samaritan.

Shire and Paladin
In August 2007,...See full deal structure in Biomedtracker

Partners: Sanofi


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