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Nuclea Biotech Buying Wilex's US Subsidiary

NEW YORK (GenomeWeb News) – Nuclea Biotechnologies and Wilex AG today announced an agreement for Nuclea to purchase Wilex Inc., a wholly owned subsidiary of Wilex AG.

Under the terms of the deal, Nuclea is purchasing all the shares of Wilex Inc. In addition to assuming all of the company's assets, Nuclea assumes responsibility for repayment of a $2.5 million loan between Wilex Inc. and Wilex AG.

Wilex AG is also eligible for single-digit royalties on net sales of Wilex Inc.'s HER2/neu and carbonic anhydrase IX, or CAIX, assays.

Concurrent with the acquisition, Wilex AG and Nuclea entered into a development deal under which Nuclea will develop an automated CAIX IVD immunohistochemistry assay for submission to the US Food and Drug Administration under the investigational device exemption. The assay is intended for the stratification of patients for a planned pivotal study of Rencarex (girentuximab) and potentially as a companion diagnostic in the adjuvant treatment of clear cell renal cell carcinoma, the firms said.

Rencarex is being developed by Munich-based Wilex AG as a treatment for clear cell renal cell carcinoma.

Nuclea will be responsible for the costs of developing the CAIX diagnostic as a contribution in kind, leading to savings of at least $2.5 million for Wilex AG, they said.

Further financial terms were not disclosed.

Based in Cambridge, Mass., Wilex Inc. develops serum-based oncoprotein diagnostics and provides an FDA-cleared and CE-marked IVD ELISA test for measuring serum HER2/neu for managing and monitoring patients with metastatic breast cancer. Wilex Inc. was formed in late 2010 when Wilex AG acquired Oncogene Science from Siemens Healthcare Diagnostics and renamed it.

Wilex Inc.'s biomarker-based tests are marketed under the Oncogene Science name.

Earlier this year, Pittsfield, Mass.-based Nuclea and Wilex Inc. announced a partnership aimed at better managing the treatment of metastatic breast cancer with the incorporation of each other's technologies.

As part of the deal announced today, "numerous" Wilex Inc. distribution and marketing agreements covering Oncogene Science tests will be transferred to Nuclea. Also, Nuclea will acquire the GMP facility in Cambridge.

Nuclea President and CEO Patrick Muraca said in a statement that the transaction provides his firm "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," Muraca said.

"The acquisition of Oncogene Science was driven by the CAIX assets," Olaf Wilhelm, CEO of Wilex Inc., and Wilex AG, added. "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 commercialize the CAIX [assay] but also further cost savings, and allows Wilex to focus on its late-stage drug pipeline and [antibody drug conjugates] technology platform."