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news.Lev Pharmaceuticals has entered into a letter agreement with the Sanquin Blood Supply Foundation, authorizing Lev to file for European marketing authorization of its lead product candidate, Cinryze, for the treatment of hereditary angioedema, also known as C1 inhibitor deficiency.
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In addition, Lev has received notification from the European Medicines Agency (EMEA) that it is eligible to submit an application for Cinrzye for Community marketing authorization through the centralized European registration procedure.
Cinryze is manufactured in Europe by Sanquin using a nano-filtration purification process under a distribution and manufacturing services agreement with Lev. Under its agreement with Sanquin, Lev currently holds the exclusive rights to market and distribute Cinryze for the treatment of hereditary angioedema in North America.
Lev is presently in discussions with Sanquin to expand its authorized territory to include certain European countries. Lev intends to submit its application to the EMEA in the fourth quarter of 2008.