Wilex and Esteve sign co-development and marketing agreement for Wilex's chimeric antibody Rencarex® in Southern Europe
Munich (Germany) and Barcelona (Spain). Wilex AG, a Munich based biopharmaceutical company dedicated to the development of novel cancer therapies, and Laboratorios del Dr. Esteve, S.A. (Esteve), Barcelona, a leading Spanish pharmaceutical-chemical group, today announced that they have signed a co-development and marketing agreement for Wilex's chimeric antibody Rencarex® in Southern Europe. Rencarex® is in clinical development for the treatment of renal cell carcinoma (RCC) and patient enrollment for a pivotal Phase III trial is expected to begin in the second quarter of 2004.
Under the terms of the agreement, Esteve will receive the exclusive marketing rights to Rencarex® for Spain, Italy, Portugal, Greece, and Andorra. Wilex will receive an undisclosed upfront payment, milestone payments, and royalties on net sales. In addition, Esteve will become co-sponsor for Spain of Wilex's Phase III trial with Rencarex® in RCC patients. Wilex will be responsible for the clinical development and manufacturing of Rencarex®, and for the global regulatory approval process.
Prof. Olaf Wilhelm, M.D., Chief Executive Officer of Wilex AG, said: "This collaboration is an important step for the further development and the overall commercialization of our lead compound Rencarex®. We are pleased that with Esteve we have gained a strong pharmaceutical partner with excellent marketing expertise and a powerful distribution network in the field of oncology in Southern Europe who will help us to realize the significant market potential of Rencarex®."
Dr. Antoni Esteve, Director of the Scientific and Commercial Operations, and Member of the Executive Committee at Esteve, states: "Esteve's aim is to have a robust and balanced development portfolio and I am satisfied because the agreement we have just signed with Wilex has contributed to this objective. Both, the product and the company, are examples of Esteve's commitment to bringing innovative pharmaceuticals to market and to establishing strategic alliances with companies that share this commitment with the R&D activities."
Rencarex® (WX-G250) is a chimeric IgG1 antibody that binds to a cell surface antigen, the MN antigen, which is found on 95% of clear Renal Cell Carcinoma (RCC) cells but not on normal kidney tissue. The antibody was originally developed at the University of Leiden, The Netherlands, by Prof. Sven Warnaar, who joined Wilex in 1999 and served as Chief Scientific Officer until June 2003 and is now member of Wilex's Supervisory Board. Wilex received Orphan Drug Status for the use of Rencarex® in the indication RCC from FDA and EMEA, which grants marketing exclusivity to Wilex for 7 years in the USA and for 10 years in the EU after receiving marketing approval. Rencarex® has completed clinical Phase II trials in RCC in which it showed strong enhancement of patient long term survival together with an excellent safety profile .
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