First treatment for post-transplant resistant, refractory and intolerant cytomegalovirus (CMV) infection or disease is now available on the Pharmaceutical Benefits Scheme (PBS)

July 1, 2025

LIVTENCITY® (maribavir) has been listed on the Pharmaceutical Benefits Scheme (PBS) for people with post-transplant cytomegalovirus (CMV) infection and disease who are resistant, refractory or intolerant to one or more prior therapies.¹
CMV infection or disease following an organ or bone marrow transplant may have serious consequences such as organ rejection.^2-4
The availability of LIVTENCITY on the PBS provides subsidised access to this medicine for eligible people who have had an organ or bone marrow transplant and developed a CMV infection.²

SYDNEY AUSTRALIA, 1 July 2025. – Takeda has welcomed the announcement that LIVTENCITY® (maribavir) has been listed on the Pharmaceutical Benefits Scheme (PBS) for people with post-transplant cytomegalovirus (CMV) infection and disease who are resistant, refractory or intolerant to one or more prior therapies.¹

CMV is a common virus in many people, where most people do not experience any symptoms.^2,5 Normally, CMV stays in their body, and it does not hurt them.² However, people with weakened immune systems after an organ or bone marrow transplant may be at high risk of becoming ill from CMV.² CMV can lead to serious consequences, including transplant failure (the transplanted organ may be rejected or not work properly).^3,4

In 2022, approximately 1,700 stem cell transplants were performed in Australia.⁶ Around 1,300 solid organ transplants were performed from deceased donors in 2024.⁷

LIVTENCITY is indicated in Australia for adults with post-transplant CMV infection and disease who are resistant, refractory or intolerant to one or more prior therapies.²

“CMV infection can have devastating consequences for transplant patients, including increased need for transfusion, increased rates of other infections, significant inflammation of the gut and lungs, and protracted periods of hospitalisation,” said Professor David Ritchie, Deputy Director of Clinical Haematology and Head of the BMT Service at the Royal Melbourne Hospital and Peter MacCallum Cancer Centre. “Having access to an oral treatment option that can be taken at home may help to reduce treatment burden.”

“We welcome the Australian government’s decision to list LIVTENCITY on the PBS for eligible patients with post- transplant CMV– a group that has long faced limited treatment options,” said Dave Pearce, General Manager Oceania (Australia and New Zealand) for Takeda.

Treatment options should be discussed with a patient’s clinician. LIVTENCITY is an Australian registered prescription antiviral medicine and can only be prescribed by a doctor.²

For more information about LIVTENCITY, refer to the Consumer Medicine Information (CMI) at https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-CMI-02101-1.

Side effects: All medicines can have side effects. The most common side effects with LIVTENCITY include changes in taste, nausea, diarrhoea, vomiting, anaemia tiredness, and fever.² Contraindications: LIVTENCITY is contraindicated in people with known hypersensitivity to maribavir or any of the ingredients in the formulation. Co-administration of LIVTENCITY with ganciclovir or valganciclovir is contraindicated.⁸ Precautions: CMV DNA levels should be monitored during and after treatment, and resistance should be checked if the patient does not respond to treatment.⁸ Interactions: Some medicines, including some immunosuppressant medicines, may interfere with LIVTENCITY and affect how it works.^2,8 Refer to the Consumer Medicine Information (CMI) for the full contraindications, special warnings and precautions of use.

Disclosure: Professor David Ritchie has served on advisory boards, received research funding for his institution, and participated in speaker engagements sponsored by Takeda, for which he received compensation. In relation to this Takeda media announcement, no compensation was provided to Prof. Ritchie, and the opinions expressed are his own. Prof. Ritchie has been briefed by Takeda on the approved use of this product.

PBS INFORMATION: This product is listed on the PBS. Authority required. Refer to PBS Schedule for full authority information.

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Patients can help by reporting any side effects they may get. Patients can report side effects to their doctor, or directly at https://www.tga.gov.au/reporting-problems. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems.

Side effects can also be reported to Takeda: [email protected].

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

For media enquiries, please contact:

Tanya West

[email protected]

+61 406 907 845

Jessica Lewington

[email protected]

+61 451 912 598

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

References

Pharmaceutical Benefits Scheme. www.pbs.gov.au.
LIVTENCITY® Consumer Medicine Information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-CMI-02101-1. Accessed June 2025.
Azevedo LS, Pierrotti LC, Abdala E, et al. Cytomegalovirus infection in transplant recipients. Clinics (Sao Paolo) 2015;70(7):515-523. doi:10.6061/clinics/2015(07)09.
Razonable RR & Humar A. Cytomegalovirus in solid organ transplantation. American Journal of Transplantation 2019;19(Supplement 3):15-24. doi: 10.1111/ajt.15280.
Lancini D, Faddy HM, Flower R, et al. Cytomegalovirus disease in immunocompetent adults. Med J Aust 2014;201(10):578–580. doi: 10.5694/mja14.00183.
Australia and New Zealand Transplant & Cellular Therapies. ANZTCT Registry. https://anztct.org.au/registry. Accessed June 2025.
Australia and New Zealand Organ Donation Registry. ANZOD. https://www.anzdata.org.au/anzod. Accessed June 2025.
LIVTENCITY® Product Information. Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-PI-02085- 1&d=20250612172310101.
© Takeda Pharmaceutical Company Limited. All rights reserved. Takeda Pharmaceuticals Australia Pty Ltd, Sydney, NSW 2000. Tel: 1800 012 612. Email: [email protected] ABN 71 095 610 870. LIVTENCITY® is a registered trademark of Takeda Pharmaceuticals International AG. TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited. Date of Preparation: June 2025. EXA/AU/LIV/0001

* LIVTENCITY® (maribavir) has been listed on the Pharmaceutical Benefits Scheme (PBS) for people with post-transplant cytomegalovirus (CMV) infection and disease who are resistant, refractory or intolerant to one or more prior therapies.1 * CMV infection or disease following an organ or bone marrow transplant may have serious consequences such as organ rejection.2-4 * The availability of LIVTENCITY on the PBS provides subsidised access to this medicine for eligible people who have had an organ or bone marrow transplant and developed a CMV infection.2 **SYDNEY AUSTRALIA, 1 July 2025.** – Takeda has welcomed the announcement that LIVTENCITY® (maribavir) has been listed on the Pharmaceutical Benefits Scheme (PBS) for people with post-transplant cytomegalovirus (CMV) infection and disease who are resistant, refractory or intolerant to one or more prior therapies.1 CMV is a common virus in many people, where most people do not experience any symptoms.2,5 Normally, CMV stays in their body, and it does not hurt them.2 However, people with weakened immune systems after an organ or bone marrow transplant may be at high risk of becoming ill from CMV.2 CMV can lead to serious consequences, including transplant failure (the transplanted organ may be rejected or not work properly).3,4 In 2022, approximately 1,700 stem cell transplants were performed in Australia.6 Around 1,300 solid organ transplants were performed from deceased donors in 2024.7 LIVTENCITY is indicated in Australia for adults with post-transplant CMV infection and disease who are resistant, refractory or intolerant to one or more prior therapies.2 “CMV infection can have devastating consequences for transplant patients, including increased need for transfusion, increased rates of other infections, significant inflammation of the gut and lungs, and protracted periods of hospitalisation,” said Professor David Ritchie, Deputy Director of Clinical Haematology and Head of the BMT Service at the Royal Melbourne Hospital and Peter MacCallum Cancer Centre. “Having access to an oral treatment option that can be taken at home may help to reduce treatment burden.” “We welcome the Australian government’s decision to list LIVTENCITY on the PBS for eligible patients with post- transplant CMV– a group that has long faced limited treatment options,” said Dave Pearce, General Manager Oceania (Australia and New Zealand) for Takeda. Treatment options should be discussed with a patient’s clinician. LIVTENCITY is an Australian registered prescription antiviral medicine and can only be prescribed by a doctor.2 For more information about LIVTENCITY, refer to the Consumer Medicine Information (CMI) at [https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-CMI-02101-1](https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-CMI-02101-1). **Side effects:** All medicines can have side effects. The most common side effects with LIVTENCITY include changes in taste, nausea, diarrhoea, vomiting, anaemia tiredness, and fever.2 **Contraindications:** LIVTENCITY is contraindicated in people with known hypersensitivity to maribavir or any of the ingredients in the formulation. Co-administration of LIVTENCITY with ganciclovir or valganciclovir is contraindicated.8 **Precautions:** CMV DNA levels should be monitored during and after treatment, and resistance should be checked if the patient does not respond to treatment.8 **Interactions:** Some medicines, including some immunosuppressant medicines, may interfere with LIVTENCITY and affect how it works.2,8 Refer to the Consumer Medicine Information (CMI) for the full contraindications, special warnings and precautions of use. **Disclosure:** Professor David Ritchie has served on advisory boards, received research funding for his institution, and participated in speaker engagements sponsored by Takeda, for which he received compensation. In relation to this Takeda media announcement, no compensation was provided to Prof. Ritchie, and the opinions expressed are his own. Prof. Ritchie has been briefed by Takeda on the approved use of this product. **PBS INFORMATION:** This product is listed on the PBS. Authority required. Refer to PBS Schedule for full authority information. ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Patients can help by reporting any side effects they may get. Patients can report side effects to their doctor, or directly at [https://www.tga.gov.au/reporting-problems](https://www.tga.gov.au/reporting-problems). Healthcare professionals are asked to report any suspected adverse events at [https://www.tga.gov.au/reporting-problems](https://www.tga.gov.au/reporting-problems). Side effects can also be reported to Takeda: [[email protected]](mailto:[email protected]). ## About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [www.takeda.com](https://www.takeda.com/). **For media enquiries, please contact: ** Tanya West [[email protected]](mailto:[email protected]) +61 406 907 845 Jessica Lewington [[email protected]](mailto:[email protected] ) +61 451 912 598 ## Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. ## References 1. Pharmaceutical Benefits Scheme. www.pbs.gov.au. 2. LIVTENCITY® Consumer Medicine Information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-CMI-02101-1. Accessed June 2025. 3. Azevedo LS, Pierrotti LC, Abdala E, et al. Cytomegalovirus infection in transplant recipients. Clinics (Sao Paolo) 2015;70(7):515-523. doi:10.6061/clinics/2015(07)09. 4. Razonable RR & Humar A. Cytomegalovirus in solid organ transplantation. American Journal of Transplantation 2019;19(Supplement 3):15-24. doi: 10.1111/ajt.15280. 5. Lancini D, Faddy HM, Flower R, et al. Cytomegalovirus disease in immunocompetent adults. Med J Aust 2014;201(10):578–580. doi: 10.5694/mja14.00183. 6. Australia and New Zealand Transplant & Cellular Therapies. ANZTCT Registry. https://anztct.org.au/registry. Accessed June 2025. 7. Australia and New Zealand Organ Donation Registry. ANZOD. https://www.anzdata.org.au/anzod. Accessed June 2025. 8. LIVTENCITY® Product Information. Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-PI-02085- 1&d=20250612172310101. © Takeda Pharmaceutical Company Limited. All rights reserved. Takeda Pharmaceuticals Australia Pty Ltd, Sydney, NSW 2000. Tel: 1800 012 612. Email: [[email protected]](mailto:[email protected]) ABN 71 095 610 870. LIVTENCITY® is a registered trademark of Takeda Pharmaceuticals International AG. TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited. Date of Preparation: June 2025. EXA/AU/LIV/0001