Lev Pharmaceuticals Inc. (OTCBB: LEVP) develops and commercializes therapeutic products for inflammatory diseases. Its lead product candidate, Cinryze (C1 inhibitor), is for the treatment of angioedema (HAE).
The company today announced a letter of agreement with the Sanquin Blood Supply Foundation, which gives Lev the OK to file for European marketing authorization of C1 to treat the life-threatening attacks associated with HAE, such as inflammation of the larynx, abdomen, face, extremities and urogenital tract. Lev also received authorization from the European Medicines Agency (EMEA) to submit an application for C1 for Community Marketing Authorization through the centralized European registration procedure.
An estimated 10,000 people in the United States suffer from HAE. Per the agreement with Sanquin, Lev holds exclusive rights to market and distribute C1 for the treatment of HAE in North America, and is in discussions with Sanquin to expand distribution to certain European countries.
Lev intends to submit its application to the EMEA in the fourth quarter of 2008, though there is no guarantee Lev will win European rights, or that EMEA will approve any application for Community Marketing Authorization filed by Lev.
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