Heidelberg Pharma AG and HealthCare Royalty have announced that they have signed a royalty financing agreement. Formal closing conditions that are expected to be fulfilled in a timely manner must still be met. Heidelberg Pharma is eligible to receive up to $115 million from the sale of its future royalties from worldwide sales of Zircaix (TLX250-CDx), a microdose radiopharmaceutical Positron Emission Tomography (PET) imaging agent for the diagnosis and follow up of clear cell renal cancer.
Zircaix is a radiolabeled form of the antibody girentuximab which binds to the tumor-specific antigen CAIX on clear cell renal cell carcinomas. Zircaix also has potential as a PET diagnostic imaging agent for other tumour types. Heidelberg Pharma developed the antibody up to a first completed Phase III clinical trial prior to licensing it to Telix Pharmaceuticals Limited (Telix), an Australian company based in Melbourne, Australia, in 2017.
Telix completed the Phase III ZIRCON trial for Zircaix in the third quarter of 2022. A rolling Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) was announced by Telix in December 2023.
Key terms of the agreement between Heidelberg Pharma and HCRx:
- Heidelberg Pharma will receive a $25 million upfront payment at closing
- Heidelberg Pharma will receive a maximum of $75 million payment upon FDA approval of Zircaix
- Heidelberg Pharma will receive a $15 million milestone payment if calendar year 2025 worldwide net product sales of Zircaix exceed a certain level
- Following the receipt by HCRx of a maximum cumulative amount, royalty payments will revert to Heidelberg Pharma and HCRx will receive a low single digit royalty tail percentage thereafter
Morgan Stanley & Co. LLC acted as sole structuring agent on the transaction.
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