Markets
ENGLISH DEUTSCH
WILEX intends to first the market launch of RENCAREX® for the adjuvant therapy of RCC after surgery in patients with risk factors for early relapse. So far, no drug has been approved by the FDA or EMEA for the adjuvant therapy of non-metastatic clear cell renal carcinoma. Other companies are also carrying out Phase III trials in this indication but they were initiated at a much later date than WILEX’s and are not expected to be completed in the near future. As a result, RENCAREX® continues to address a high unmet medical need.
The Company presumes that the peak sales potential for the indication of clear cell renal cell carcinoma is about USD 500 million.
Commercialisation Outlook
In 1999, Centocor had assigned an exclusive license on the RENCAREX® antibody to WILEX and retained an option to the U.S. marketing rights. In 2004, WILEX acquired the option to the U.S. marketing rights from Centocor and thus holds the worldwide marketing rights on RENCAREX® except South Europe.
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 for RENCAREX® in the respective region.
WILEX has been 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. Assuming a positive outcome of the ongoing ARISER study (since 2004), it is expected to file for marketing approval in Europe and in the United States.
WILEX has 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. This agreement represents the first step of the commercialisation and partnering strategy of the Company with RENCAREX®. In April 2011 WILEX granted US commercialisation rights for RENCAREX® to Prometheus Laboratories Inc. (Prometheus), San Diego, CA, USA.
