Nuclea Biotechnologies Inc. acquires WILEX Inc. and extends their cooperation with WILEX AG


Ad-hoc release pursuant to § 15 Wertpapierhandelsgesetz
(German Securities Trading Act)

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Munich, Germany, 06. September 2013. WILEX AG (ISIN DE0006614720/ WL6 / FSE) and Nuclea Biotechnologies, Inc., Pittsfield, MA, USA, (Nuclea) today signed a share deal and development agreement. Nuclea acquires all shares of WILEX Inc., Cambridge, MA, USA, (Oncogene Science), a wholly owned US subsidiary of WILEX AG.

Nuclea will in return assume responsibility for repayment of USD 2.5 million under an intercompany loan between WILEX Inc. and WILEX AG. In addition, WILEX AG is eligible for single-digit royalties on net sales on the HER-2/neu and CAIX assays.

Concurrently and as essential part of the overall deal, WILEX AG and Nuclea entered into a development agreement under which Nuclea will develop an automated CAIX IVD IHC assay (“CAIX Dx”) to be submitted for FDA allowance under the investigational device exemption (“IDE”). This CAIX Dx is intended to be used for patient stratification in a planned pivotal study with RENCAREX® and as a potential future companion diagnostic in the adjuvant treatment of clear cell renal cell carcinoma. Nuclea will bear the costs for the development of this CAIX Dx as a contribution in kind which will lead to savings of at least USD 2.5 million for WILEX AG.

Nuclea and WILEX Inc. have been partners in marketing the serum HER-2/neu ELISA since early 2013. Today’s agreement includes the transfer to Nuclea of numerous distribution and marketing agreements for all marketed Oncogene Science biomarker tests (HER-2/neu ELISA, CAIX assays and other Research Use Only tests) which complement Nuclea’s wide range of products and services.

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About Nuclea
Nuclea Biotechnologies, Inc. is headquartered in Pittsfield, Massachusetts with additional operations in Worcester, Massachusetts. Nuclea has developed and is commercializing unique diagnostic tests for colon, breast, leukaemia, lung and prostate cancer. Nuclea also performs research leading to novel molecular oncology companion diagnostics for the pharmaceutical and biotechnology industries.

About WILEX Inc.
WILEX Inc. is a wholly owned US subsidiary of WILEX AG, Munich, Germany. The team of 11 employees has many years’ experience in developing and manufacturing biomarker tests for oncology, which are marketed under the brand name Oncogene Science. The product portfolio includes enzyme-linked immunosorbent assays (ELISA) and immunohistochemical (IHC) assays for in vitro diagnostic (IVD) and research use only (RUO). With the aim of supporting treatment regimens for cancer patients worldwide WILEX Inc. offers biomarker tests for measuring oncogenes, growth factor receptors (HER-2/neu, EGFR), proteases and protease inhibitors (uPA, PAI-1, TIMP-1), as well as markers of hypoxia (CAIX). WILEX Inc. is based in Cambridge, MA, USA and also provides GMP and ISO certified manufacturing services. More information is available at

WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused on oncology, the Company develops diagnostic and therapeutic product candidates for the specific detection and targeted treatment of various types of cancer based on antibodies and small molecules. The subsidiary Heidelberg Pharma GmbH offers preclinical contract research services and an antibody drug conjugate (ADC) technology platform. The business model comprises research and product development as well as the commercialisation of its activities. Our customers and partners include leading international pharmaceutical companies. WILEX AG is listed at the Frankfurt Stock Exchange. ISIN DE0006614720 / WKN 661472 / Symbol WL6. More information is available at

Corporate Communications
Katja Arnold (CIRO) & Sylvia Wimmer
Tel.: +49 (0)89-41 31 38-29
Mobil: +49 (0)160 93 60 30 22
Email: investors[at]

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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