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DGAP-News: WILEX AG / Key word(s): Agreement WILEX AG regains US rights for RENCAREX(R) from Prometheus

07.11.2013 / 07:25

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PRESS RELEASE

WILEX regains US rights for RENCAREX(R) from Prometheus

Munich, Germany, 07 November 2013. WILEX AG (ISIN DE0006614720/ WL6 / FSE) and Prometheus Laboratories Inc. (Prometheus), San Diego, CA, USA, agreed as of 31 October 2013 on the terms of the termination of the 2011 license agreement on RENCAREX(R) (Girentuximab). As announced on 3 June 2013, Prometheus and WILEX decided to finalise the cooperation and to discuss the formalities and timing regarding the termination.

According to the settlement agreement, WILEX regains the US commercialisation rights for RENCAREX(R) and will receive a final payment of USD 1.75 million covering Prometheus' obligations under the collaboration agreement for the RENCAREX(R) development costs. Prometheus will no longer participate in the RENCAREX(R) development. The parties have no further mutual obligations.

WILEX has received upfront and milestone payments of USD 39 million plus 40% of development costs since the beginning of the collaboration.

RENCAREX(R) is a Phase III product candidate for adjuvant therapy of non-metastatic clear cell Renal Cell Carcinomas (ccRCC). In October 2012, the Phase III ARISER trial failed to meet its primary endpoint. The final analysis showed no improvement in median disease-free survival following treatment with RENCAREX(R) compared to placebo. However, WILEX carried out an extensive subgroup and biomarker analysis and presented positive subgroup data at the ASCO Annual Meeting in June 2013. The results of this retrospective analysis showed that RENCAREX(R) has a therapeutic effect in the subgroup of patients with a high score of the antigen CAIX. Disease-free survival in this group showed a clinically and statistically significant improvement compared to both placebo and patients with a low CAIX score.

Professor Olaf G. Wilhelm, CEO of WILEX AG, commented: 'We look back on a very valuable collaboration with Prometheus. Due to the top line data of RENCAREX(R) and the delay of a marketable product, Prometheus' request to terminate was not a surprise to us. We are delighted that we came to an agreement that works for both parties. The return of the US rights for RENCAREX(R) offers us new and broader options for its commercialisation.'

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PRESS RELEASE: WILEX AG regains US rights for RENCAREX(R) from Prometheus