Nuclea Biotechnologies Acquires Wilex' U.S. Subsidiary

Nuclea Biotechnologies will acquire Wilex (Oncogene Science), the U.S. subsidiary of German-based Wilex AG. Nuclea will buy all Wilex shares for an undisclosed price, plus repay a $2.5 million intercompany loan between Wilex and its corporate parent. In return, Wilex AG will be eligible for single-digit royalties on net sales of cancer diagnostic assays for HER-2/neu and CAIX.

Nuclea and Wilex have partnered to market the serum HER-2/neu ELISA since earlier this year, and had identified several synergies. The agreement includes the transfer to Nuclea of numerous distribution and marketing agreements for the marketed Oncogene Science test, while Nuclea acquires Wilex' GMP facility in Cambridge, MA.

In what the companies termed an essential component of their deal, Wilex AG agreed to join Nuclea in developing an automated CAIX IVD IHC assay to be submitted for an FDA allowance under its investigational device exemption. Nuclea agreed to bear development costs for CAIX Dx as an in-kind contribution leading to savings of at least $2.5 million for Wilex AG. The CAIX Dx is intended for patient stratification in a planned pivotal study with Rencarex® and as a potential future companion diagnostic in adjuvant treatment of clear cell renal cell carcinoma.

"This transaction delivers not only a partner to develop and commercialize the CAIX Dx but also further cost savings and allows Wilex to focus on its late-stage drug pipeline and ADC technology platform," Professor Olaf G. Wilhelm, CEO of Wilex and its corporate parent, said in a statement. "The acquisition of Oncogene Science was driven by the CAIX assets."

Wilex specializes in serum-based oncoprotein diagnostics, providing 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 company's CAIX IHC kit is used to identify the antigen Carbonic Anhydrase IX in various types of cancer. Nuclea identifies biomarkers and develops diagnostic assays under its Decision Dx™ brand that can help predict which treatment courses will be effective for specific patients, based on their genetics.

Patrick J. Muraca, Nuclea's president & CEO, said the commercial platform and the GMP facility acquired through the transaction will serve as a catalyst for adoption of Nuclea's Decision Dx™ fatty acid synthase, a CLIA-validated assay used in clinical trials and under regulatory review.

"This acquisition presented us with an opportunity to strengthen Nuclea's portfolio and continue to move into the commercial realm," Muraca said.

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