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)

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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®.

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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


Corporate Communications
Sylvia Wimmer
Tel.: +49 (0)89-41 31 38-29
Email: investors[at]wilex.com
Grillparzerstr. 10, 81675 Munich, Germany
For press enquiries
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Katja Arnold (CIRO)
Tel.: +49 (0)89-41 31 38-126
Tel.: +49-89-210 228-40
Mobil: +49 160 9360 3022
E-Mail: katja.arnold[at]mc-services.eu

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will”, “should”, “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial position, earnings, achievements, or industry results, to be materially different from any future results, earnings or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

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