DRI Healthcare Increases Investment in KalVista Pharmaceuticals' Ekterly Amid FDA Approval

DRI Healthcare Trust announced that KalVista Pharmaceuticals received FDA approval for Ekterly (sebetralstat), the first oral on-demand therapy for hereditary angioedema attacks. DRI Healthcare will receive a tiered royalty on worldwide net sales and has invested $127 million in KalVista. The approval expands DRI Healthcare's portfolio and demonstrates the value of pre-approval transactions.

DRI Healthcare Trust (TSX: DHT.UN) (TSX: DHT.U) has announced that KalVista Pharmaceuticals (Nasdaq: KALV) has received FDA approval for Ekterly (sebetralstat), the first oral on-demand therapy for hereditary angioedema (HAE) attacks. This approval marks a significant milestone for both companies and the HAE community.

Ekterly, a plasma kallikrein inhibitor, is designed to address the unpredictable attacks associated with HAE, providing patients with a new treatment option that offers immediate access to medication. The drug has demonstrated rapid symptom relief and reduced attack severity compared to placebo, as shown in the Phase 3 KONFIDENT clinical trial [2].

DRI Healthcare Trust, a pioneer in global pharmaceutical royalty monetization, will receive a tiered royalty on worldwide net sales of Ekterly. The royalty structure includes a 6.00% royalty on net sales up to and including $500 million, a 1.10% royalty on net sales above $500 million and up to and including $750 million, and a 0.25% royalty on net sales above $750 million. Additionally, KalVista has elected to receive an additional $22 million payment as part of the November 2024 royalty transaction, increasing DRI Healthcare's total investment to $127 million [1].

The approval of Ekterly expands DRI Healthcare's portfolio, adding a new royalty stream and demonstrating the value of pre-approval transactions. "The addition of the long-dated Ekterly cash flows demonstrates the value that a pre-approval transaction can bring to our portfolio," said Ali Hedayat, Chief Executive Officer of DRI Healthcare.

KalVista plans to launch Ekterly in the U.S. immediately, allowing physicians to start prescribing the drug for the treatment of HAE attacks. The company has also established KalVista Cares™, a comprehensive patient support program that offers personalized services and resources to eligible individuals, including assistance with insurance coverage and access support [3].

The approval of Ekterly represents a significant advancement in HAE treatment, providing patients and physicians with an important and welcome option for managing the condition. "Until now, on-demand treatment relied on injectable subcutaneous or intravenous administration, often resulting in delayed intervention," said Marc A. Riedl, MD, Professor of Medicine and Clinical Director, U.S. Hereditary Angioedema Association Center at the University of California, San Diego, and an investigator for the KONFIDENT phase 3 trial. "Having an oral option empowers patients to treat attacks early, which aligns with treatment guidelines and advances our goal as physicians to reduce the overall burden of disease."

References:
[1] https://www.newswire.ca/news-releases/dri-healthcare-comments-on-fda-approval-and-our-increased-investment-in-kalvista-pharmaceuticals-ekterly-r-sebetralstat--893169294.html
[2] https://www.worldpharmaceuticals.net/news/kalvista-secures-fda-approval-for-ekterly-to-treat-hae-attacks/
[3] https://ir.kalvista.com/news-releases/news-release-details/kalvista-pharmaceuticals-announces-fda-approval-ekterlyr