Well being Canada Approves Label Growth for Telix’s Illuccix® to Embody Affected person Choice for PSMA-Focused Remedy

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MELBOURNE, Australia, Oct. 04, 2024 (GLOBE NEWSWIRE) — Telix Prescription drugs Restricted (ASX: TLX, Telix, the Firm) in the present day proclaims that Well being Canada has authorised the usage of Illuccix® (equipment for the preparation of gallium Ga 68 gozetotide injection) in choosing sufferers for PSMA¹-targeted radionuclide remedy.

The label growth signifies that Illuccix is now authorised in Canada to pick out sufferers with progressive metastatic castration-resistant prostate most cancers (mCRPC) for remedy with the one authorised PSMA-targeted radionuclide remedy (lutetium (¹⁷⁷Lu) vipivotide tetraxetan, or Pluvicto®²). To qualify for PSMA-targeted remedy, sufferers should be imaged with an authorised gallium-based PSMA-PET³ agent⁴, comparable to Illuccix.

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The newest approval expands the scientific utility for Illuccix, which has been authorised in Canada since October 2022 for staging and re-staging intermediate and high-risk prostate most cancers, and localizing tumor tissue in recurrent prostate most cancers⁵. Illuccix is out there throughout Canada by way of Telix’s companion Isologic Modern Radiopharmaceuticals (Isologic), whose distribution community providers 265 hospitals and clinics nationwide.

Dr. Francois Lamoureux, President of the Canadian Affiliation of Nuclear Drugs mentioned, “As focused radionuclide remedy for prostate most cancers turns into extra prevalent in Canada, it’s essential for medical doctors to grasp who might or might not reply to these remedies. Within the VISION trial⁶, ⁶⁸Ga-PSMA-11 PET/CT⁷ was proven to be a strong and extremely correct instrument for detecting prostate most cancers and informing affected person administration.”

André Gagnon, President of Isologic added, “PSMA-targeted theranostics are broadly thought of to be the way forward for prostate most cancers remedy. It’s subsequently great that we are able to now provide Illuccix on this further setting, for sufferers who’re candidates for PSMA-targeted remedy, by way of our nationwide community.”

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Kevin Richardson, Chief Government Officer, Telix Precision Drugs continued, “We welcome Well being Canada’s choice to broaden the label for Illuccix. This may additional enhance entry to superior prostate most cancers imaging and supply medical doctors with essential info to assist make remedy selections with confidence. This displays Telix’s ongoing dedication to supporting sufferers with most cancers and empowering the medical doctors who take care of them throughout extra phases of the affected person journey.”

Healthcare professionals in Canada can order Illuccix kits by e mail orders@isologicradiopharm.ca or by cellphone 1-877-505-4711 ext 0. Unit doses could be ordered from native radiopharmacies.

About Telix Prescription drugs Restricted

Telix is a biopharmaceutical firm centered on the event and commercialization of therapeutic and diagnostic radiopharmaceuticals and related medical gadgets. Telix is headquartered in Melbourne, Australia, with worldwide operations in america, Europe (Belgium and Switzerland), and Japan. Telix is creating a portfolio of scientific and business stage merchandise that goals to handle vital unmet medical wants in oncology and uncommon illnesses. Telix is listed on the Australian Securities Trade (ASX: TLX).

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Go to www.telixpharma.com for additional details about Telix, together with particulars of the most recent share worth, bulletins made to the ASX, investor and analyst displays, information releases, occasion particulars and different publications which may be of curiosity. You too can observe Telix on X and LinkedIn.

About Illuccix®

Telix’s lead imaging product, gallium-68 (⁶⁸Ga) gozetotide injection (also called ⁶⁸Ga PSMA-11 and marketed underneath the model identify Illuccix®), has been authorised by the U.S. Meals and Drug Administration (FDA)⁸, by the Australian Therapeutic Items Administration (TGA) ⁹, and by Well being Canada¹⁰. No different Telix product has obtained a advertising authorization in any jurisdiction.

Indications and utilization (Canada)

Illuccix®, after radiolabeling with gallium (⁶⁸Ga), is indicated to be used with positron emission tomography (PET) of prostate particular membrane antigen (PSMA) constructive lesions in males with prostate most cancers:

• with suspected metastasis who’re appropriate for preliminary definitive remedy;
• with suspected recurrence with elevated serum prostate particular antigen (PSA) degree; and
• for identification of sufferers with progressive metastatic castration-resistant prostate most cancers (mCRPC), for whom PSMA-targeted remedy is indicated.

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Illuccix is a Schedule C radiopharmaceutical product.

Click on right here for authorised product monograph in Canada.

Telix Investor Relations

Ms. Kyahn Williamson
Telix Prescription drugs Restricted
SVP Investor Relations and Company Communications
E mail: kyahn.williamson@telixpharma.com

Authorized Notices

It’s best to learn this announcement along with our threat elements, as disclosed in our most lately filed studies with the Australian Securities Trade (ASX) or on our web site.

The data contained on this announcement just isn’t meant to be a proposal for subscription, invitation or suggestion with respect to securities of Telix Prescription drugs Restricted (Telix) in any jurisdiction, together with america. The data and opinions contained on this announcement are topic to alter with out notification. To the utmost extent permitted by regulation, Telix disclaims any obligation or endeavor to replace or revise any info or opinions contained on this announcement, together with any forward-looking statements (as referred to under), whether or not because of new info, future developments, a change in expectations or assumptions, or in any other case. No illustration or guarantee, specific or implied, is made in relation to the accuracy or completeness of the data contained or opinions expressed in the midst of this announcement.

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This announcement might include forward-looking statements that relate to anticipated future occasions, monetary efficiency, plans, methods or enterprise developments. Ahead-looking statements can typically be recognized by means of phrases comparable to “might”, “count on”, “intend”, “plan”, “estimate”, “anticipate”, “imagine”, “outlook”, “forecast” and “steerage”, or the adverse of those phrases or different related phrases or expressions. Ahead-looking statements contain identified and unknown dangers, uncertainties and different elements which will trigger our precise outcomes, ranges of exercise, efficiency or achievements to vary materially from any future outcomes, ranges of exercise, efficiency or achievements expressed or implied by these forward-looking statements. Ahead-looking statements are primarily based on Telix’s good-faith assumptions as to the monetary, market, regulatory and different dangers and issues that exist and have an effect on Telix’s enterprise and operations sooner or later and there could be no assurance that any of the assumptions will show to be appropriate. Within the context of Telix’s enterprise, forward-looking statements might embody, however will not be restricted to, statements about: the initiation, timing, progress and outcomes of Telix’s preclinical and scientific trials, and Telix’s analysis and growth packages; Telix’s capacity to advance product candidates into, enrol and efficiently full, scientific research, together with multi-national scientific trials; the timing or chance of regulatory filings and approvals for Telix’s product candidates, manufacturing actions and product advertising actions; Telix’s gross sales, advertising and distribution and manufacturing capabilities and techniques; the commercialisation of Telix’s product candidates, if or once they have been authorised; Telix’s capacity to acquire an enough provide of uncooked supplies at affordable prices for its merchandise and product candidates; estimates of Telix’s bills, future revenues and capital necessities; Telix’s monetary efficiency; developments regarding Telix’s opponents and business; and the pricing and reimbursement of Telix’s product candidates, if and after they’ve been authorised. Telix’s precise outcomes, efficiency or achievements could also be materially completely different from these which can be expressed or implied by such statements, and the variations could also be opposed. Accordingly, you shouldn’t place undue reliance on these forward-looking statements.

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©2024 Telix Prescription drugs Restricted. The Telix Prescription drugs® and Illuccix® names and logos are emblems of Telix Prescription drugs Restricted and its associates – all rights reserved.

¹ Prostate-specific membrane antigen.
² Pluvicto is a registered trademark of Novartis AG and/or its associates.
³ Imaging of prostate-specific membrane antigen with positron emission tomography.
⁴ Per the Pluvicto product monograph: Tumor PSMA expression needs to be verified earlier than remedy with Pluvicto. In scientific trials, sufferers had been chosen on the premise of PSMA expression detected by PET diagnostic imaging utilizing ⁶⁸Ga-PSMA-11.
⁵ Telix ASX disclosure 14 October 2022.
⁶ ClinicalTrials.gov ID: NCT03511664. VISION examine sponsored by Endocyte, a Novartis firm. Telix offered Illuccix (TLX591-CDx) for PSMA-PET imaging.
⁷ Positron emission tomography/computed tomography.
⁸ Telix ASX disclosure 20 December 2021.
⁹ Telix ASX disclosure 2 November 2021.
¹⁰ Telix ASX disclosure 14 October 2022.

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