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Cinryze (IV)

Shire Pharmaceuticals Group PLC

Drug Names(s): C1-INH-nanofiltered, C1-esterase inhibitor, C1-esteraseremmer-N, nanofiltered Cetor, SHP616

Description: Cinryze (C1-esterase inhibitor, or C1-INH) is a human plasma protein that mediates inflammation and coagulation. In Europe, C1-INH, produced by several manufacturers, has been used to treat HAE safely and effectively for more than 30 years, and is widely accepted as the treatment of choice for HAE.

Normal C1-INH helps to regulate the complex biochemical interactions of blood-based systems involved in inflammation and coagulation, and C1-INH is known to be either a major or minor inhibitor of at least seven proteins involved in these systems. More specifically, C1-INH is known to inhibit three key biochemical pathways underlying inflammation and/or coagulation – the complement system, the contact pathway of intrinsic coagulation and the fibrinolytic system.

HAE is caused by a defective gene for C1-INH, and this defect is passed on in families - a child has a 50% chance of inheriting this disease if one parent is affected. The absence of family history, however, does not rule out HAE diagnosis, and as many as 20% of HAE cases involve patients who appear to have had a spontaneous mutation of the C1-INH gene at conception. The genetic defect results in production of either inadequate or nonfunctioning C1-INH protein.

Deal Structure: LevPharma and Sanquin
LevPharma have certain rights to C1-INH technology through agreements with Sanquin Blood Supply Foundation (Sanquin), an Amsterdam-based not-for-profit organization that provides blood and plasma products and related services, carries out research and provides education, primarily in the Netherlands.

Sanquin has been producing and selling successive generations of C1-INH, prepared from human plasma, in the Netherlands for over 30 years for the treatment of HAE. Continuous product development efforts at Sanquin have resulted in the current, highly purified product which has been marketed since 1997. Despite its long record of use in Europe, however, C1-INH, has never been introduced in the United States. Through a supply and distribution agreement with Sanquin, LevPharma have the exclusive right to market and sell C1-INH prepared by Sanquin for the treatment of HAE in North America and certain other geographic regions.

ViroPharma and...See full deal structure in Biomedtracker

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