Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today
announces that the United States (U.S.) Food and Drug
Administration (FDA) has accepted the filing of its New Drug
Application (NDA) for TLX007-CDx, a new and proprietary cold kit
(“Kit”) for the preparation of PSMA-PET imaging1 for prostate
cancer. The PDUFA2 goal date is March 24, 2025.
If approved, the new Kit will enable use of a
PSMA imaging product with a considerably extended geographic
distribution radius from a nuclear pharmacy compared to currently
approved gallium-68 (68Ga) based agents. Its innovative properties
are designed to facilitate more flexible production, including with
higher activity 68Ga sourced from both newer high activity
generators and cyclotrons powered by the ARTMS® QUANTM Irradiation
System™3 and GE FASTlab™4 solid and liquid target production
system. Through this NDA, Telix’s objective is to further enhance
patient access to PSMA-PET imaging and the clinical benefits of
68Ga imaging to underserved populations across the U.S., using
Telix’s established nuclear pharmacy distribution partnerships and
industry-leading on-time reliability.
PSMA-PET imaging represents a major advancement
in prostate cancer management and in the U.S. has replaced
conventional imaging methods (bone scan, CT scan) as the standard
of care after initial diagnosis and biochemical recurrence5.
Despite this major medical advancement, only a relatively small
fraction of the 3.4 million men living with prostate cancer in
America have undergone a PSMA-PET imaging scan6,7.
Dr Christian Behrenbruch, Managing Director and
Group CEO of Telix stated, “We have seen rapid adoption and
geographic expansion of PSMA-PET imaging with our first commercial
product Illuccix®. This filing acceptance is an important step
towards further improving equity of access and reinforcing our
commitment to innovation in prostate cancer to continue to meet the
needs of healthcare professionals and their patients. We now look
forward to working with the FDA to bring TLX007-CDx to American men
living with prostate cancer, including those residing in
underserved communities and regions where access to state-of-the
art imaging remains limited.”
About Telix
Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on
the development and commercialisation 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 FDA8, by the
Australian Therapeutic Goods Administration (TGA) 9, and by Health
Canada10. 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
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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.
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The information contained in this announcement
is not intended to be an offer for subscription, invitation or
recommendation with respect to shares of Telix Pharmaceuticals
Limited (Telix) in any jurisdiction, including the United States.
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.
The information contained in this announcement is subject to change
without notification.
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”,
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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 the Company’s
good-faith assumptions as to the financial, market, regulatory and
other risks and considerations that exist and affect the Company’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
studies, 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, manufacturing activities and product marketing
activities; the commercialisation of Telix’s product candidates, if
or when they have been approved; 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. You
should read this announcement together with our risk factors, as
disclosed in our most recently filed reports with the ASX or on our
website.
To the maximum extent permitted by law, Telix
disclaims any obligation or undertaking to publicly update or
revise any forward-looking statements contained in this
announcement, whether as a result of new information, future
developments or a change in expectations or assumptions.
©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®
and Illuccix® names and logos are trademarks of Telix
Pharmaceuticals Limited and its affiliates – all rights
reserved.
1 Imaging of prostate-specific membrane antigen with positron
emission tomography.2 Prescription Drug User Fee Act. 3 Telix ASX
disclosure 11 April 2024. For further information visit:
https://www.artms.ca/4 FASTlab is a trademark of GE Healthcare and
its affiliates.5 NCCN Clinical Practice Guidelines in Oncology
(NCCN Guidelines®) for Prostate Cancer V.4.2024.6 NIH Common Cancer
Sites — Cancer Stat Facts. Accessed May 2024.7 Company analysis
based on proprietary and public domain data.8 Telix ASX disclosure
20 December 2021.9 Telix ASX disclosure 2 November 2021.10 Telix
ASX disclosure 14 October 2022.