WILEX and IBA terminate marketing partnership – Global rights to REDECTANE® diagnostic agent revert to WILEX
Ad-hoc release pursuant to § 15 Wertpapierhandelsgesetz
(German Securities Trading Act)
Munich, Germany, 30 April 2014. WILEX AG (ISIN DE0006614720 / WL6 / FSE) and IBA Pharma SPRL (IBA S.A.: Reuters IBAB.BR and Bloomberg IBAB.BB), Louvain-la-Neuve, Belgium, today agreed to terminate their licence agreement for REDECTANE® signed in 2008 and retransfer all rights granted to IBA under the licence agreement with immediate effect to WILEX, particularly the exclusive licence granted for the production and global marketing of REDECTANE®.
IBA will make all marketing, development and regulatory data collected under this partnership available to WILEX and will support WILEX in transferring the technology to a potential new manufacturer or marketing partner. IBA will also reimburse costs to WILEX AG.
WILEX now is in a position to contact new partners for the external development, financing, production and marketing of REDECTANE®.
+++ End of Ad hoc release +++
REDECTANE® (INN: 124I-Girentuximab) is a radiolabelled form of the antibody Girentuximab, which binds to the antigen CAIX on clear cell renal cell carcinoma. The antibody-based radiopharmaceutical REDECTANE® could support physicians in diagnosing renal cancers. Determining that no clear cell renal cell cancer is present constitutes an important goal. This could fundamentally change therapy planning for renal cancer patients and avoid potentially unnecessary surgery. Furthermore, REDECTANE® may also prove suitable for monitoring response to treatment and for diagnosing other kinds of tumours. The Phase III REDECT trial completed in 2010 showed that REDECTANE® can differentiate between clear cell and non-clear cell renal cell cancer and that PET/CT with REDECTANE® was clearly superior to CT.
In recent months, WILEX has drawn up the development strategy and trial design for the confirmatory Phase III trial (REDECT 2), for which it received a special protocol assessment (SPA) from the FDA in the fourth quarter of 2013. WILEX AG will no longer conduct the REDECT 2 trial, but aims to arrange the financing, development and commercialisation for REDECTANE® externally.
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused on oncology, the Company develops diagnostic and therapeutic product candidates based on antibodies and small molecules, which are available for out-licensing. The subsidiary Heidelberg Pharma GmbH offers preclinical contract research services and an antibody drug conjugate (ADC) technology platform. Our customers and partners include leading international pharmaceutical companies. WILEX is listed at the Frankfurt Stock Exchange: ISIN DE0006614720 / WKN 661472 / Symbol WL6. More information is available at www.wilex.com
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