WILEX Inc. and Nuclea Biotechnologies Inc. announce cooperation

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Munich, Germany / Pittsfield, USA, 20 March 2013. WILEX AG (ISIN DE0006614720/ WL6 / FSE) today announced a partnership between its US subsidiary WILEX Inc., Cambridge, MA, USA, and Nuclea Biotechnologies, Inc., Pittsfield, MA, USA, (Nuclea) for the commercialisation of the serum HER-2/neu (blood) ELISA test. The cooperation will greatly advance research and identification of biomarkers, a vital component in the growing field of personalised medicine. Financial terms were not disclosed.

Nuclea discovers biomarkers (genes and proteins) and develops diagnostic assays that can help predict which courses of treatment will be effective for certain patients, depending on their genetic makeup. Nuclea has the capability and expertise to perform 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.

WILEX Inc. 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. The IVD is reimbursed by insurance companies and has a unique CPT code 83950. HER-2, Human Epidermal Growth Factor Receptor 2, is a protein which is overexpressed in various cancer types. The serum HER-2 level is valuable to doctors for monitoring response to therapy and progression of disease.

By harnessing this powerful IVD and using it in conjunction with other clinical tests, this joint project could be a significant clinical offering in the breast cancer field. In April, clinical testing will begin in Nuclea’s newly designed, state-of-the-art laboratory in Pittsfield, and will allow oncologists greater access to the HER-2/neu ELISA test.

“Nuclea is excited about the new partnership,” said Patrick J. Muraca, president & CEO of Nuclea. “Both companies seek to develop new biomarkers with the goal of making 21st century cancer treatments more personal and effective. With our combined experience in the production and commercialisation of biomarkers, it seemed very natural for us to work together as pioneers in the field of breast cancer.”

Professor Olaf G. Wilhelm, CEO of WILEX Inc. and WILEX AG, commented: “Since Nuclea understands and focuses on gene and protein expression profiles in tumours, the serum HER-2 test is an important addition to their profiling efforts. Besides using our HER-2 ELISA in its CLIA lab Nuclea will also start R&D and validation of this test in early breast cancer and possibly other indications.”

About Nuclea

Nuclea Biotechnologies Inc. is headquartered in Pittsfield, MA, with additional operations in Worcester, MA. Nuclea has developed and is commercialising eleven unique diagnostic tests for colon, breast, leukemia, lung and prostate cancer. Nuclea also performs research leading to novel molecular oncology therapeutics and diagnostics for the pharmaceutical and biotechnology industries. More information is available at www.nucleabio.com.

About WILEX Inc.

WILEX Inc. is a wholly owned US subsidiary of WILEX AG, Munich, Germany. The team 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.


Corporate Communications
Katja Arnold (CIRO)
Grillparzerstr. 10
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Email: investors@wilex.com 


Nuclea Biotechnologies Inc.
Media Relations
Greg D’Agostino
Cell +1 617.388.6477
Office +1 617.695.0369
Email: greg@libertysquaregroup.com

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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