Iodofalan (131I)

MELBOURNE, Australia, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara®1), an agent for the imaging of glioma. The application has been granted priority review and designated a PDUFA2 goal date of 26 April 2025, paving the way for a U.S. commercial launch in 20253. Pixclara (18F-floretyrosine or 18F-FET) is a PET agent for the characterisation of progressive or recurrent glioma from treatment related changes in both adult and pediatric patients. FET PET is already included in international clinical practice guidelines for the imaging of gliomas4, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S. Given its potential to address significant unmet medical need, Pixclara has been designated as an orphan drug5 and granted fast track designation6 by the FDA. There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumours of the central nervous system, particularly in the post-treatment setting. Conventional MRI7 imaging techniques have several limitations, including a lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumour progression or treatment-related causes. This can yield inconclusive results and delay time-sensitive treatment decisions8. With low survival rates and the need to make rapid decisions, precision imaging is paramount. Subject to regulatory approval, Pixclara has the potential to address this need, enabling patients in the U.S. to receive greater clarity in their diagnosis and treatment decision making. Telix is also reviewing the potential use of Pixclara as a “companion” diagnostic agent for TLX101-Tx, the investigational neuro-oncology drug currently in development, which targets the same amino acid transporter mechanism with therapeutic targeted radiation. Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, said, “Telix believes that the FDA approval of Pixclara will drive a step-change for brain cancer imaging in the U.S., and bring it into line with a more advanced standard of care currently used in other markets. There is currently a critical need for better imaging in brain cancer, and Telix is dedicated to delivering precision medicine solutions that address patient needs and enhance both cancer imaging and treatment outcomes.” About TLX101-CDx TLX101-CDx (Pixclara) is a PET imaging agent, which has been granted fast track and orphan drug designations by the FDA as an imaging agent for the characterisation of glioma. TLX101-CDx targets membrane transport proteins known as LAT and LAT29. This enables Pixclara to be potentially utilised as a companion diagnostic agent to TLX101 (131I-iodofalan, or 131I-IPA), Telix’s LAT1-targeting investigational glioblastoma (GBM) therapy, currently under investigation in the Telix’s IPAX-210 and IPAX-Linz11 studies. About gliomas in the U.S. Gliomas are very diffusely infiltrative tumours that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) neoplasm that originates from glial cells, accounting for approximately 30% of all brain and CNS tumours and 80% of all malignant brain tumours12. In the U.S., there are six cases of gliomas diagnosed per 100,000 people every year. GBM is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.13. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients14, with an expected survival duration of 12-15 months from diagnosis15. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)16, by the Australian Therapeutic Goods Administration (TGA) 17, and by Health Canada18. No other Telix product has received a marketing authorisation in any jurisdiction. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX) or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix® and Pixclara® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Pixclara trade name is subject to final regulatory approval. 1 Brand name subject to final regulatory approval.2 Prescription User Drug Fee Act. 3 Subject to FDA marketing authorsation approval.4 Joint European Association of Nuclear Medicine//European Association of Neurooncology/Response Assessment in Neurooncology practice guidelines/Society for Nuclear Medicine and Molecular Imaging procedure standards for the clinical use of PET imaging in gliomas.5 Telix ASX disclosure 6 October 2020.6 Telix ASX disclosure 16 April 2024. Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. More: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track7 Magnetic resonance imaging.8 Smith NJ et al. J Nucl Med. 2023.9 Large amino acid transporters 1 and 2.10 Telix media release 8 August 2023. ClinicalTrials.gov ID: NCT05450744.11 Telix media release 22 November 2022.12 Goodenberger et al. Cancer Genet. 2012.13 Ostrom 2022, CBTRUS (Central Brain Tumor Registry of the United States) Statistical Report.14 Park et al. Journal of Clinical Oncology. 2010.15 Ostrom et al. Neuro Oncol. 2018.16 Telix ASX disclosure 20 December 2021.17 Telix ASX disclosure 2 November 2021.18 Telix ASX disclosure 14 October 2022.

MELBOURNE, Australia, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today provides an update on its revenue and operational performance for the quarter ended 30 September 2024 (Q3 2024). Revenue update, full year guidance reaffirmed Unaudited total revenue of approximately US$135 million (AU$201 million1), primarily generated from sales of Telix’s prostate cancer imaging product Illuccix® in the Precision Medicine (Px) business unit. This represents an increase of 55% on the prior corresponding quarter (Q3 2023: US$87 million or AU$133 million) and an increase of 9% on the prior quarter (Q2 2024: US$124 million or AU$189 million).Revenue generated from sales of Illuccix in the United States (U.S.) was approximately US$131 million (AU$195 million).Total revenue2 generated for the year to date is US$374 million (AU$565 million).The Company reaffirms its full year 2024 revenue guidance of US$490 million to US$510 million (AU$745 million to AU$776 million), representing a ~48 to 54% increase on full year 2023.Guidance for full year 2024 R&D expenditure remains at an expected 40 to 50% increase compared with full year 2023, funded by earnings from product sales.Revenue guidance is based on approved products in jurisdictions with a marketing authorization. (See Guidance Disclaimer for further information). Q3 2024 Overview Telix continued to deliver strong revenue growth from sales of Illuccix in the U.S. as the Company executed on its sales and marketing strategy to drive adoption, increase market share and reinforce its position in the urology market as a leading provider of PSMA3 imaging, committed to innovation in imaging, surgical intervention and treatment of urological cancers. The Company further strengthened its cash reserves, raising AU$650 million in convertible bonds with strong investor support4. The proceeds from the capital raise provide funding to accelerate key clinical development programs across the Company’s diagnostic and therapeutic portfolio, pursue strategically significant M&A transactions, and invest in global supply chain and manufacturing capabilities. In support of the Company’s strategy to further expand its North American manufacturing footprint, Telix announced the acquisition of RLS (USA) Inc for US$230 million upfront5, as detailed in the operational highlights for Telix Manufacturing Solutions. Dr Christian Behrenbruch, Managing Director and Group Chief Executive Officer, Telix, said, “Our achievements over the past quarter reinforce Telix’s leadership in the radiopharmaceutical sector. We continue to make excellent progress across multiple late-stage assets in our therapeutic pipeline, while preparing to commercialize three new imaging agents within our precision medicine portfolio. Telix’s strong cash position and earnings generation mean the business is well-positioned to pursue high-value opportunities across the pipeline and invest in the infrastructure that underpins commercial dose delivery and long-term value creation.” During the period, Telix announced a business reorganization aligning operations across four business units to reflect its focus as a therapeutics-led radiopharmaceutical company committed to precision oncology. The updated business model comprises: Therapeutics, Precision Medicine (Diagnostics), Lightpoint (MedTech) and Telix Manufacturing Solutions (TMS). Full year 2024 financial results will be reported in line with this structure (with Lightpoint included under Precision Medicine for financial reporting purposes). Operational highlights by business unit Therapeutics Therapeutics are at the core of Telix, as it seeks to improve and extend patient life through targeted radiopharmaceutical therapies. Prostate cancer therapy, TLX591 (177Lu rosopatamab tetraxetan): Following allowance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) in April 2024, the ProstACT GLOBAL Phase III trial6 is now enrolling patients at its first U.S. sites, in addition to ongoing patient dosing at sites in the Asia Pacific region. Current enrolment is focused on recruiting Part 1 of the trial, a 30-patient safety and manufacturing/CMC7 lead-in cohort.During the quarter, the Company participated in a multidisciplinary meeting with the FDA for alignment on Part 2 of ProstACT GLOBAL, the randomization treatment expansion arm of the trial. This incorporated a positive consultation on the primary and secondary endpoints, patient enrolment strategy, and incorporation of key design learnings from other recently reported PSMA radionuclide therapy mCRPC8 studies, with the goal of de-risking the trial.Kidney cancer therapy, TLX250 (177Lu-girentuximab): The Phase II STARLITE-2 trial of TLX250 in patients with advanced clear cell renal cell carcinoma9, established the maximum-tolerated dose (MTD) of TLX250 when administered in combination with nivolumab. Telix intends to shortly provide an update and interim data on these initial dosing cohorts. The trial is expected to proceed with an expansion cohort at the MTD before concluding.Brain cancer therapy, TLX101 (131I-iodofalan, or 131I-IPA): The Company’s IPAX-1 Phase I trial was published in Neuro-Oncology Advances, confirming the safety and tolerability profile, and early efficacy of TLX101 therapy, in combination with external beam radiation therapy (EBRT), in recurrent glioblastoma (GBM), the most common and aggressive form of primary brain cancer10. The IPAX-211 and IPAX-Linz12 trials in front-line and recurrent GBM continue to dose patients. Precision Medicine (Px) The Precision Medicine business is focused on the commercialization of Telix’s imaging agents, which are key to informing treatment decisions and selecting patients for therapy. Over the past quarter, the Company progressed regulatory filings for several products globally: Prostate cancer imaging, TLX007-CDx: The FDA accepted the filing of a New Drug Application (NDA) for a new and proprietary cold kit for the preparation of PSMA-PET13 imaging for prostate cancer. The PDUFA14 goal date is 24 March 2025. If approved, this will significantly transform patient access and production flexibility for PSMA-PET, as an additional option for prostate cancer imaging, alongside Illuccix.Kidney cancer imaging, TLX250-CDx (Zircaix®15, 89Zr-girentuximab): Telix is on track to resubmit the Biologics License Application (BLA) for its kidney cancer imaging agent in November 2024, consistent with prior guidance, and continues to target a full U.S. commercial launch in 202516.Telix has announced Cardinal Health, Inc. will be a commercial radiopharmaceutical distributor to supply finished unit doses of Zircaix for the U.S.17, subject to regulatory approval. Concurrently the expanded access (EAP) and named patient (NPP) programs for TLX250-CDx continue to dose patients across the U.S., Australia and Europe in a significant area of unmet patient need. The EAP is active at 20 sites across the U.S. with additional site activations underway.Primary results from the Phase III ZIRCON trial were published in The Lancet Oncology, where TLX250-CDx, a first-in-class investigational PET agent, was found to be highly accurate in detecting and characterizing clear cell renal cell carcinoma in patients with indeterminate renal masses18.Brain cancer imaging, TLX101-CDx, (Pixclara®19, 18F-floretyrosine or 18F-FET): An NDA was submitted to the FDA for a PET diagnostic agent for the characterization of progressive or recurrent glioma (brain cancer) from treatment-related changes in both adult and pediatric patients. Telix is targeting a full U.S. commercial launch in 2025, subject to regulatory approval. TLX101-CDx is currently being used in the IPAX-2 and IPAX-Linz therapeutic studies as companion diagnostic. An EAP for TLX101-CDx has opened in the U.S. and is enrolling patients.Illuccix global regulatory submissions: After a protracted administrative review and delayed clockstop, the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, or BfArM) has restarted the clock on the Company’s marketing authorization application for the European Union and provided guidance for an approval decision expected in January 2025.Applications for the United Kingdom (UK) and Brazil are progressing as expected with their respective regulators. In the UK, the Company has responded to all questions, no substantive issues have been raised and an approval decision is expected in the coming months. The Company still expects an ANVISA (Brazil) approval decision in the coming quarter. Telix Manufacturing Solutions (TMS) TMS is a global network of facilities for the production and delivery of patient doses worldwide. It is focused on building manufacturing capacity and improving the technology and processes for producing precision medicines and therapies at scale. TMS works closely with key isotope supply chain and regional distribution partners to achieve this. RLS (USA) Inc acquisition: The Company announced an agreement to acquire RLS, America’s only Joint Commission-accredited radiopharmacy network distributing PET, SPECT20 and therapeutic radiopharmaceuticals. The acquisition will significantly expand Telix’s North American manufacturing footprint and establish the basis of a next-generation radiometal production network to benefit Telix and select strategic commercial partners. The purchase price includes an upfront cash consideration of US$230 million and deferred cash consideration up to a maximum of US$20 million, contingent on achievement of certain milestones. The acquisition is expected to close in the first quarter of 2025.Good Manufacturing Practice (GMP) and Wholesaler Distribution Authorization (WDA) accreditation: Site inspections were successfully completed for all three manufacturing facilities in Belgium. GMP accreditation for the Herstal and Liège facilities was renewed, with Herstal also granted a new WDA. GMP accreditation for the new Brussels South facility is expected in H1 2025, which paves the way to future commercial supply of doses starting in 2025. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)21, by the Australian Therapeutic Goods Administration (TGA)22, and by Health Canada23. No other Telix product has received a marketing authorization in any jurisdiction. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com _______________________________________1 Conversion to AUD$ is at an average exchange rate realised during Q3 2024 of AUD$1 = US$0.6722 Total revenue year-to-date is provided on unaudited basis.3 Prostate-specific membrane antigen.4 Telix ASX disclosure 24 July 2024.5 Telix ASX disclosure 23 September 2024.6 ClinicalTrials.gov ID: NCT06520345.7 Chemistry manufacturing and controls.8 Metastatic castration-resistant prostate cancer.9 ClinicalTrials.gov ID: NCT05239533.10 Pichler et al. Neuro Onc Adv. 2024.11 ClinicalTrials.gov ID: NCT05450744.12 EudraCT Number: 2021-006426-43.13 Imaging of prostate-specific membrane antigen with positron emission tomography.14 Prescription Drug User Fee Act (PDUFA) date – the date by which the FDA must respond to the application.15 Brand name subject to final regulatory approval.16 The FDA did not accept the initial BLA due to an issue in the CMC package. This is now being remediated. See Telix ASX disclosure 31 July 2024.17 Telix media release 17 September 2024.18 Shuch et al. Lancet Oncol. 2024.19 Brand name subject to final regulatory approval.20 Single-photon emission computed tomography.21 Telix ASX disclosure 20 December 2021.22 Telix ASX disclosure 2 November 2021.23 Telix ASX disclosure 14 October 2022. Guidance Disclaimer The stated revenue guidance is based on expected global and domestic economic conditions and is subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially. As such, investors are cautioned not to place undue reliance on this guidance and in particular Telix cannot guarantee a particular result. In compiling financial forecasts, a number of key variables that may have a significant impact on guidance have been identified and are listed below. Key variables that could cause actual results to differ materially include: the success and timing of research and development activities; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation or regulations that affect product production, distribution, pricing, reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and Telix’s ability to protect its patents and other intellectual property. This announcement has been authorised for release by the Telix Pharmaceuticals Limited Board of Directors. Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX) or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix®, Pixclara® and Zircaix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Pixclara and Zircaix brand names are subject to final regulatory approval.