DRI Healthcare Trust Announces Acquisition of a Royalty Interest in the Worldwide Sales of pegcetacoplan Including Empaveli® /Aspaveli® for the Treatment of Paroxysmal Nocturnal Hemoglobinuria
– Transaction builds on DRI's history of investing in innovative therapies for the treatment of
hematological conditions –
– Creative deal structure provides DRI with option to increase interest in the future –
– Fast-growing product with long-term horizon extends the duration of DRI's cash flows –
TORONTO, July 21, 2022 /CNW/ - DRI Healthcare Trust (TSX: DHT.UN) (TSX: DHT.U) ("DRI" or "the Trust") today announced that a wholly-owned subsidiary of DRI has acquired a royalty interest in pegcetacoplan for an upfront purchase price of US$24.5 million, with an option to increase its interest in pegcetacoplan in the future.
Pegcetacoplan is the active molecule in the first targeted C3 therapy for use in adults with Paroxysmal Nocturnal Hemoglobinuria ("PNH") and was approved by the US Food and Drug Administration ("FDA") and the European Medicines Agency in 2021. It is marketed in the US by biopharmaceutical company, Apellis Pharmaceuticals Inc. ("Apellis"), under the brand name Empaveli and outside the US by rare disease-focused biopharmaceutical company, Swedish Orphan Biovitrum AB (“Sobi”), including in the EU under the brand name Aspaveli. Neither Apellis nor Sobi are parties to the transaction.
"We are very pleased to announce the addition of pegcetacoplan to our portfolio," said Behzad Khosrowshahi, Chief Executive Officer of DRI Healthcare Trust. "Empaveli and Aspaveli provide a novel treatment option for a very serious disease and represent a significant advancement in the standard of care. The innovative option element of the deal structure gives us the ability to increase the Trust's exposure to pegcetacoplan should we choose to do so. This transaction provides us with another growth asset with a long-term horizon, extending the duration of our portfolio to approximately nine years."
Pegcetacoplan is also in development for additional pipeline indications including Geographic Atrophy ("GA"), Cold Agglutinin Disease and C3 Glomerulopathy. The FDA has granted fast-track status and has accepted and granted priority review of a New Drug Application submitted by Apellis for pegcetacoplan for the treatment of GA, with a Prescription Drug User Fee Act (PDUFA) target action date of November 26, 2022. If approved, pegcetacoplan would be the first drug approved for the treatment of GA.
The transaction entitles DRI to a <1% royalty on the worldwide net sales of pegcetacoplan, subject to a cap at net sales of US$500 million in each calendar year, above which DRI will not be entitled to any royalty. As part of the transaction, DRI has an option to increase the annual sales cap to US$1.1 billion in return for a one-time payment by DRI of US$21.0 million. DRI is entitled to receive quarterly royalty payments in respect of net sales of all formulations of pegcetacoplan commencing January 1, 2022 and will be paid on a three-quarter lag. DRI's royalty entitlement will step down upon the expiry of the relevant patents in each jurisdiction. The royalty term is expected to expire in the US in the fourth quarter of 2031 and in the EU in the second quarter of 2032.
Pegcetacoplan is a 15-amino acid cyclic peptide conjugated to each end of a PEG linker that binds to and inhibits C3 activation. In 2021, Empaveli was the first targeted C3 therapy approved for IL and 2L treatment for adults with PNH in the United States. In the EU, Aspaveli is only approved for 2L use for PNH patients who are still anemic after treatment with a C5 inhibitor for at least three months.
PNH is a rare, chronic, life-threatening genetic disorder characterized by complement pathway-mediated destruction of red blood cells. About half of clinically meaningful PNH patients have severe PNH with a degree of hemolysis that requires frequent transfusions. Symptoms of PNH include fatigue due to low hemoglobin levels, anemia and thrombosis. Treatments include transfusions, anti-thrombotic agents and complement cascade modulators. Approximately 30% of patients on the current standard of care are not well served and remain transfusion dependent. Additionally, another 30% of patients experience extravascular hemolysis.
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., a pioneer in global pharmaceutical royalty monetization. Throughout its history, DRI Capital has provided capital to biopharma innovators, including inventors, institutions, and biopharma companies, building a diversified portfolio of interests in medicines that have a demonstrable positive impact on the world, acquiring dependable, patent-protected cash flow streams derived from the sales of those important drugs. Active across a broad range of therapeutic areas, DRI Capital has deployed more than $2 billion, acquiring more than 60 royalties on 40-plus drugs, including Eylea, Spinraza, Zytiga, Remicade, Keytruda and Stelara. 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". To learn more visit drihealthcaretrust.com.
This news release may contain forward-looking information within the meaning of applicable securities legislation. Forward-looking information generally can be identified by the use of forward-looking words such as "expect", "continue", "anticipate", "intend", "aim", "plan", "believe", "budget", "estimate", "forecast", "foresee", "close to", "target" or negative versions thereof and similar expressions. Some of the specific forward-looking information in this news release may include, among other things, statements that if FDA approval is successful, pegcetacoplan would be the first drug approved for Geographic Atrophy, and that our royalty entitlement in pegcetacoplan will step down upon the expiry of the relevant patent in each jurisdiction and is expected to expire in the US in the fourth quarter of 2031 and in the EU in the second quarter of 2032. Forward-looking information is based on a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond the Trust's control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These risks and uncertainties include, but are not limited to, those that are disclosed in the Trust's most recent annual information form. The forward-looking information in this news release is based on our assumptions regarding the performance of our royalty interest in Empaveli®, including with respect to worldwide sales. All forward-looking information in this news release speaks as of the date of this news release. The Trust does not undertake to update any such forward-looking information whether as a result of new information, future events or otherwise except as required by law. Additional information about these assumptions and risks and uncertainties is contained in the Trust's filings with securities regulators, including its latest annual information form and Management's Discussion and Analysis. These filings are also available at the Trust's website at dricapital.com.
SOURCE DRI Healthcare Trust
Stewart Busbridge, Chief Operating Officer, Tel: (416) 863-1865; David Levine, Director, Investor Relations, Tel: (416) 324-5738, [email protected]
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