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