INESSS recommends LIVTENCITY™ (maribavir) for public reimbursement in Quebec

For Canadian Audiences Only

TORONTO, ON – June 22, 2023 – Takeda Canada Inc. (“Takeda”) is pleased to announce a positive recommendation from the Institut national d’excellence en santé et en services sociaux (INESSS) for LIVTENCITY™ (maribavir) for public reimbursement in Quebec. LIVTENCITY is indicated for the treatment of adults with post-transplant cytomegalovirus (CMV) infection/disease who are refractory (with or without genotypic resistance) to one or more prior antiviral therapies.¹ The positive INESSS recommendation is the first step in the process to secure public access of LIVTENCITY in Quebec.

“With INESSS’ positive recommendation of LIVTENCITY, we have impactful progress for patients with CMV,” said Dr. Me-Lihn Luong, Clinical Associate Professor Clinical Microbiology and Infectious Diseases, CHUM. “The addition of a new oral drug against refractory CMV would be welcome news for patients.”

INESSS recognized that refractory CMV infection or disease, although rare, can be a challenging complication after receiving a transplant and is associated with significant mortality and morbidity. The recommendation was based on the findings of the SOLSTICE Phase 3 clinical study.

“Takeda is committed to creating effective and innovative treatment options, that address the needs of Canadians,” said Rute Fernandes, General Manager, Takeda in Canada. “We’re delighted with INESSS’ positive recommendation for LIVTENCITY, which underscores the necessity for an approved CMV treatment for post-transplant patients and we look forward to engaging with the other provinces to increase accessibility to this treatment.”

About LIVTENCITY

LIVTENCITY is a selective orally bioavailable benzimidazole riboside antiviral drug with a novel mechanism of action against human CMV (HCMV).¹ LIVTENCITY attaches to the UL97 encoded kinase at the adenosine triphosphate (ATP) binding site, as a consequence abolishing phosphotransferase needed in processes such as DNA replication, encapsidation, and nuclear egress of viral capsids.¹

For contraindications, warnings, precautions, adverse reactions, drug-drug interactions, dosing, and conditions of clinical use, consult the LIVTENCITY product monograph at https://www.takeda.com/en-ca/

About CMV

CMV, a beta herpesvirus, commonly infects people around the world; serologic evidence of prior infection can be found in 40%-100% of various adult populations.² Typically remaining dormant and asymptomatic in the body, CMV may reactivate during periods of immunosuppression. Patients with compromised immune systems such as those who receive immunosuppressants associated with various types of transplants including hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT), are at risk of developing serious complications of CMV.^3,4

Out of the estimated 200,000 transplants in adults per year globally, CMV is one of the most common viral infections experienced by transplant recipients, with an estimated incidence rate between 16%-56% in SOT recipients and 30%-70% in HSCT recipients.^3,5,6,7 Reactivation of CMV in transplant patients can lead to serious outcomes such as the loss of the transplanted organ and, in extreme cases, can be fatal.^2,8

About Takeda Canada Inc.

Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK), a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit: https://www.takeda.com/en-ca/

Media Contacts:

Amanda Jacobs

[email protected]

+1 647-798-2231

LIVTENCITY™ and the LIVTENCITY Logo™ are trademarks of Takeda Pharmaceuticals International AG

TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited, used under license.

References

1. LIVTENCITY™ Product Monograph. September 23, 2022.
2. de la Hoz R. Diagnosis and treatment approaches to CMV infections in adult patients. J Clin Virol. 2002;25:S1-S12.
3. Azevedo L, Pierrotti L, Abdala E, et al. Cytomegalovirus infection in transplant recipients. Clinics. 2015;70(7):515-523.
4. Razonable RR, Eid AJ. A Viral infections in transplant recipients. Minerva Med. 2009;100(6):23.
5. Shannon-Lowe & Emery. The effects of maribavir on the autophosphorylation of ganciclovir resistant mutants of the cytomegalovirus UL97 protein. Herpesviridae 2010, 1:4.
6. Styczynski J. Who Is the Patient at Risk of CMV Recurrence: A Review of the Current Scientific Evidence with a Focus on Hematopoietic Cell Transplantation. Infect Ther. 2018;7:1-16.
7. World Health Organization. Haematopoietic Stem Cell Transplantation HSCtx. Accessed December 2, 2020. https://www.who.int/transplantation/hsctx/en/
8. Kenyon M, Babic A, eds. The European Blood and Marrow Transplantation Textbook for Nurses. Springer International Publishing; 2018.