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

September 9, 2013

Munich, Germany / Pittsfield, USA / Cambridge, USA- WILEX AG (ISIN DE0006614720/ WL6 / FSE) and Nuclea Biotechnologies, Inc., Pittsfield, MA, USA, (Nuclea) today signed a share deal agreement under which Nuclea acquires all shares of WILEX Inc., Cambridge, MA, USA, (Oncogene Science), a wholly owned US subsidiary of WILEX AG. Under the terms of the deal, Nuclea will assume all the assets of WILEX Inc. and will also 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.

WILEX Inc. (Oncogene Science) specialises in serum based oncoprotein diagnostics and provides the only FDA cleared and CE marked IVD ELISA test for the measurement of serum HER-2/neu in the management and monitoring of patients with metastatic breast cancer. In addition, the company listed the CAIX IHC kit as a Class I 510(k)-exempt medical device with the FDA. This immunohistochemistry (IHC) kit is used to identify the antigen Carbonic Anhydrase IX (CAIX) which plays an important role in various types of cancer. Beside these important assays other Oncogene Science biomarker tests (e.g. TIMP-1 ELISA, EGFR ELISA and uPA ELISA) currently used as research use only (RUO) complement Nuclea’s wide range of products and services.

Nuclea identifies biomarkers and develops proprietary diagnostic assays under the brand Decision Dx™ that can help predict which courses of treatments will be effective for specific patients, based on their genetic makeup. Nuclea performs in vitro diagnostic (IVD) assays in the area of oncology in a certified laboratory (CLIA) and also has access through its business relationships with hospitals and research institutions to patients in need of such tests. One such assay is Nuclea’s Decision Dx™ Fatty Acid Synthase for use in a variety of cancers.

Nuclea and WILEX Inc. have been partners in marketing the serum HER-2/neu ELISA since early 2013 and had identified several synergies. The agreement includes the transfer to Nuclea of numerous distribution and marketing agreements for the marketed Oncogene Science tests and Nuclea will acquire the GMP (Good Manufacturing Practice) facility in Cambridge.

“This deal is a major step for Nuclea,” said Patrick J. Muraca, President & CEO of Nuclea. “This acquisition presented us with an opportunity to strengthen Nuclea’s portfolio and continue to move into the commercial realm. The commercial platform and the GMP facility acquired through this transaction will serve as a catalyst for the adoption of Nuclea’s Decision Dx™ Fatty Acid Synthase, which is currently available as a CLIA validated assay, used in clinical trials and under regulatory review. With our expertise and existing relationships, I’m confident that these additions will expand our footprint in the field of personalized medicine.”   

Professor Olaf G. Wilhelm, CEO of WILEX Inc. and WILEX AG, commented: “The acquisition of Oncogene Science was driven by the CAIX assets. The future development of RENCAREX® requires now a companion diagnostic based on CAIX for patient stratification. This transaction delivers not only a partner to develop and commercialise the CAIX Dx but also further cost savings and allows WILEX to focus on its late stage drug pipeline and ADC technology platform”.

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. www.nucleabio.com

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 www.oncogene.com.

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 www.wilex.com.

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