FDA grants Fast Track designation to WILEX’s RENCAREX® for the adjuvant therapy of clear cell Renal Cell Carcinoma

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Munich, Germany, 05 October 2011. WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) announced today, that RENCAREX® has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) of its investigational compound RENCAREX® which is currently undergoing the pivotal Phase III trial ARISER for the adjuvant treatment of patients with non-metastatic clear cell Renal Cell Carcinoma (ccRCC) at high risk of relapse after surgery. The Fast Track designation triggers a milestone payment of USD 2.5 million from the US partner Prometheus Laboratories Inc., with whom WILEX signed a licence agreement for RENCAREX® at the end of April 2011.

“We are pleased with this decision from the FDA. No drug has been approved to date by the FDA or EMA for the adjuvant therapy of non-metastatic clear cell renal cell carcinoma. RENCAREX® was granted Orphan Drug status in the USA and in Europe and is of major relevance for those patients with this aggressive type of cancer” said Dr Paul Bevan, Head of R&D and Member of the Executive Management at WILEX AG.

Fast Track Designation in the United States is a process designed to expedite the review of drugs to treat serious diseases which fill an unmet medical need. Fast Track addresses a broad range of serious diseases. Fast Track designation must be requested by the drug company and can be initiated at any time during the drug development process. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, and could lead to earlier drug approval and access by patients.

About RENCAREX® and the ARISER study

The drug candidate RENCAREX® is based on the antibody Girentuximab, which binds to the tumour-specific antigen CA IX an antigen that is overexpressed in clear cell renal cell carcinomas. The therapeutic antibody makes the tumour visible to the endogenous immune system, recruiting natural killer cells which can destroy any existing cancer cells. RENCAREX® should inhibit the further growth and recurrence of ccRCC a particularly aggressive type of cancer and kill cancer cells, thereby prolonging the disease-free survival of patients.

ARISER (Adjuvant RENCAREX Immunotherapy trial to Study Efficacy in non-metastasised Renal cell carcinoma) is an international, multicentre, randomised Phase III trial that examines the efficacy of the antibody RENCAREX® in comparison to placebo in the treatment of clear cell renal cell cancer patients following complete or partial surgical removal of the affected kidney in patients with no detectable metastases. The ARISER trial involves 864 patients, who received the study medication in once-weekly infusions over a period of 24 weeks. The last patient completed treatment in February 2009. Following the occurrence of the 100th relapse, the first interim analysis for futility was carried out in late 2007. The IDMC recommended that the trial be continued because it will probably deliver a significant result. The process of the interim analysis for efficacy has been started in the first quarter of 2011.

WILEX has granted commercialisation rights for RENCAREX® for certain countries of Southern Europe to the Spanish pharmaceutical company Laboratorios del Dr. Esteve, Barcelona, Spain and US commercialisation rights to Prometheus Laboratories Inc., San Diego, CA, USA.


WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused on oncology, the company has a broad portfolio of near-to-market therapeutic and diagnostic products for the targeted treatment and specific detection of various types of cancer. The company’s therapeutic product candidates are based on antibodies and small molecules. Through its US subsidiary WILEX Inc. in Cambridge, MA, WILEX markets a portfolio of research use only and in vitro diagnostic tests under the brand Oncogene Science. These diagnostic tests could be developed as companion diagnostics in clinical trials and for therapy monitoring. The wholly owned subsidiary Heidelberg Pharma AG gives WILEX access to an attractive and highly promising antibody drug conjugate technology platform and a pre-clinical service business. The business model of WILEX covers the entire value chain in the oncology market and comprises research, technology, development collaboration as well as sales and marketing. WILEX’s customers and partners include leading international pharmaceutical companies. Website: http://www.wilex.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6

Corporate Communications
Katja Arnold (CIRO)
Grillparzerstr. 10
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
E-Mail: investors@wilex.com

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