Commercialisation Outlook

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In 1999, Centocor had assigned an exclusive licence on the RENCAREX® antibody to WILEX and retained an option to the U.S. marketing rights.

RENCAREX® received Orphan Drug Designation from the FDA in 2001 and from the EMEA in 2002. This Orphan Drug Designation prevents similar antibodies targeting MN/CA IX for use in RCC from entering the market 7 years in the United States and 10 years in the European Union after the marketing approval in the respective region.

WILEX was granted Fast Track Status in October 2011 from the U.S. regulatory authority FDA for the Phase III ARISER study with adjuvant RENCAREX® in RCC. In 2004 WILEX partnered RENCAREX® for co-development and commercialisation in certain countries of South Europe (Spain, Italy, Portugal, Greece, and Andorra) with the Spanish pharmaceutical company Laboratorios del Dr. Esteve.

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