Denos Health Management, the former primary stakeholder of PET diagnostics manufacturer Cyclopharma France and U.S., is starting from scratch in the radiopharmaceutical industry following its sale of the French-based enterprise, with the launch of Zionexa.

Formerly the U.S. division of Cyclopharma, the new company will focus on clinically developing and commercializing innovative companion diagnostic and therapeutic radiopharmaceuticals to enhance patient care. Its establishment follows the recent acquisition of Cyclopharma by Curium.

“It was the right time,” Peter Webner, Zionexa CEO and former CEO of Cyclopharma U.S., told HCB News. “They were looking to get their equity out. Curium was looking at growing its footprint and a decision was made at the board level for Cyclopharma that they wanted to focus on the new products coming down the pipe.”

Announced in April and completed in May, the deal provided Curium access to nearly 100 employees and seven PET radiopharmacies throughout France, enabling it "comprehensive coverage of all 140 PET centers across France,” as stated in its announcement of the transaction.

Existing R&D and international operations of Cyclopharama though were not included in the agreement.

In addition to acquiring Cyclopharma’s U.S. division, Denos Health Management purchased the rights to the pipeline of Cyclopharma France, including EstroTep, a PET tracer cleared for use only in France.

Denos Health Management also adds value from early pharmacodynamics studies (Phase 0), early human kinetics and dosimetry and proof of concept imaging (Phase 1), target development and process and chemistry improvement (Phase 2), pivotal clearance trials (Phase 3), commercialization and distribution, and market access strategy.

Zionexa plans to gain FDA clearance for EstroTep and is currently working on clinical trials for several other products including IMAKinib, designed to target the EGFR protein in lung cancer.

A third product is also in the works. Webner could not comment on it at this time but did say that all three are fluorine-based and would “fit naturally into the mix of commercial and academic cyclotron capabilities in the U.S.”

EstroTep is planned as the first of the three to be submitted to the FDA for market clearance.

Submissions are set to begin this summer.

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