DRI Healthcare Trust Comments on FDA Approval of VONJO (pacritinib)

DRI Healthcare Trust (CNW Group/DRI Healthcare Trust)TORONTO, March 1, 2022 /CNW/ – DRI Healthcare Trust (TSX: DHT.UN) (TSX: DHT.U) (“DRI”) today announced that it has been notified by CTI BioPharma Corp. (“CTI”) that the U.S. Food and Drug Administration (“FDA”) has approved VONJO (pacritinib) for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with platelets below 50 x 109/L. Myelofibrosis is a bone marrow cancer that results in formation of fibrous scar tissue and can lead to thrombocytopenia and anemia, weakness, fatigue and enlarged spleen and liver. This approval triggers the completion of the transaction with CTI for a tiered royalty on VONJO for US$60 million, as announced on August 25, 2021.

“We are very pleased that the FDA has approved VONJO, a groundbreaking drug that addresses a high unmet medical need, offering a meaningful new treatment option for adults with myelofibrosis with thrombocytopenia, a patient population for whom therapies do not currently exist,” said Behzad Khosrowshahi, Chief Executive Officer of DRI Healthcare Trust. “We would like to congratulate our partners at CTI who have worked tirelessly to develop VONJO, culminating in this approval.”

“Importantly, we can now complete the royalty element of this transaction. The addition of the VONJO royalty provides an attractive, growing cash flow profile and extends our overall portfolio duration. Furthermore, this transaction highlights our ability to offer flexible deal structures that provide DRI with excellent assets that meet our acquisition criteria, while providing for the objectives of our partners such as CTI.”

The transaction entitles DRI to receive royalties on the net sales of VONJO in the United States equal to 9.6% of the first US$125 million of annual U.S. net sales, 4.5% of annual U.S. sales between US$125 million and US$175 million of annual U.S. net sales, 0.5% of annual U.S. sales between US$175 million and US$400 million of annual U.S. net sales, with no entitlement above US$400 million of annual U.S. net sales. CTI is entitled up to an additional US$25 million in the event that VONJO sales exceed certain thresholds prior to Q3 2023.

The completion of the royalty transaction is expected to occur on or about March 4, 2022.

About DRI Healthcare Trust

DRI Healthcare Trust provides unitholders with differentiated exposure to the anticipated growth in the global pharmaceuticals and biotechnology markets. Our business model is focused on managing and growing a diversified portfolio of pharmaceutical royalties with the aim to deliver attractive growth in cash royalty receipts over the long term. DRI Healthcare Trust is an unincorporated open-ended trust governed by the laws of the Province of Ontario, externally managed by its manager, DRI Capital Inc. DRI Healthcare Trust’s units are listed and trade on the Toronto Stock Exchange in Canadian dollars under the symbol “DHT.UN” and in U.S. dollars under the symbol “DHT.U”.

About VONJO (pacritinib)

Pacritinib is an oral kinase inhibitor with activity against wild type Janus Associated Kinase 2 (JAK2), mutant JAK2V617F form and FMS-like tyrosine kinase 3 (FLT3) which contribute to signaling of a number of cytokines and growth factors that are important for hematopoisesis and immune function. Myelofibrosis is often associated with dysregulated JAK2 signaling. Pacritinib has higher inhibitory activity for JAK2 over other family members, JAK3 and TYK2. At clinically relevant concentrations, pacritinib does not inhibit JAK1. Pacritinib exhibits inhibitory activity against additional cellular kinases (such as CSF1R and IRAK1), the clinical relevance of which is unknown.

VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

SOURCE DRI Healthcare Trust


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