Telix Pharmaceuticals and ANMI Partner for Prostate Cancer Imaging

Telix Pharmaceuticals and ANMI Partner for Prostate Cancer Imaging

ID: 564832

(Thomson Reuters ONE) -


MELBOURNE, Australia and LIÈGE, Belgium, Oct. 24, 2017 (GLOBE NEWSWIRE) -- Telix
Pharmaceuticals Limited (Telix, Company), a clinical-stage biopharmaceutical
company focused on the development of diagnostic and therapeutic products based
on targeted radiopharmaceuticals or molecularly-targeted radiation (MTR), is
pleased to announce that it has entered into a development and commercialization
partnership with Advanced Nuclear Medicine Ingredients SA (ANMI).

Under the terms of the agreement, Telix and ANMI will partner to commercialise
ANMI's 68Ga-HBED-CC-PSMA (68Ga-PSMA-11) kit (Kit), a proven technology used to
accurately image and stage metastatic prostate cancer, in the US market. Telix
will also offer the Kit on a worldwide basis as a companion diagnostic imaging
agent to the Company's prostate cancer therapeutic (TLX-591)1. The agreement
includes filing a Drug Master File (DMF) for the Kit, and completion of the
necessary clinical trials to obtain marketing authorisation from the US Food and
Drug Administration (FDA).

68Ga-PSMA-11 is a proven technology solution for the accurate imaging and
staging of metastatic prostate cancer. PSMA-11 (also known as DKFZ-112) is a
small molecule that binds to prostate-specific membrane antigen (PSMA), a well-
validated target that is highly expressed in both localised and metastatic
prostate cancer, including castrate-resistant prostate cancer. PSMA-11
radiolabelled with 68Ga (gallium) is a convenient and clinically efficient
approach to imaging prostate cancer with Positron Emission Tomography (PET).
PSMA is also targeted by Telix to treat prostate cancer with 177Lu (lutetium).

Telix Co-Founder and CEO Dr. Christian Behrenbruch stated, "ANMI's 'shake and
inject' kit allows for the rapid, room-temperature labelling of the PSMA-11




ligand with gallium. This has become a well-proven approach for imaging prostate
cancer and ANMI's technology makes the process extremely efficient in the
clinical setting. ANMI's radiochemists are the best and brightest in the
industry and we are pleased to be working with the team to tackle prostate
cancer."

ANMI Co-Founder and CEO Ludovic Wouters noted, "Prostate cancer affects one in
eight men in the US3 and the market opportunity is very significant. We are
pleased to be working with Telix to deliver our solution to patients in the US."
ANMI Co-Founder and CSO Dr. Sam Voccia added, "Telix is building a portfolio of
diagnostic and therapeutic urology products that we believe will help to drive
physician interest and market share for our products."

As part of the implementation of the agreement, Telix and ANMI will establish a
joint-venture (JV) company, with ANMI selling Kits to the JV on an exclusive
basis for the US Market. Telix will be appointed as the sales and marketing
partner to the JV, via the Company's US subsidiary.

About Telix Pharmaceuticals Limited

Telix is a clinical-stage biopharmaceutical company focused on the development
of diagnostic and therapeutic products based on targeted radiopharmaceuticals
or molecularly-targeted radiation (MTR). The Company is developing an advanced
portfolio of oncology products that address significant unmet medical need in
renal, prostate and brain (glioblastoma) cancer. For more information
visit www.telixpharma.com.

About ANMI SA

ANMI SA is a precursor supplier for radiometal labelled radiopharmaceuticals and
a global service provider in the nuclear medicine field, located in Liège,
Belgium. ANMI has developed innovative solutions to facilitate the scalable
synthesis of "theranostic" radiopharmaceuticals and to ease their daily
production in hospitals. ANMI's vision is focused on increasing patient access
to new highly specific theranostic radiopharmaceuticals through streamlined and
cost-effective production processes. For more information visit www.anmi.be

About Prostate-Specific Membrane Antigen (PSMA)

PSMA is a cancer target (cell surface antigen) that is highly upregulated in
prostate cancer cells but has relatively little presence in normal tissues. PSMA
is a highly validated and promising target for a range of diagnostic and
therapeutic strategies in prostate cancer.

About PSMA-11

PSMA-11 is a small molecule (ligand) that targets and binds to PSMA. When
radiolabelled with an isotope such as 68Ga (gallium), metastatic prostate cancer
can be imaged using Positron Emission Tomography (PET) with excellent
sensitivity and specificity. PET is a highly effective and widely used imaging
modality in the management of cancer.

About ANMI's PSMA-11 kit

ANMI's PSMA-11 kit is the first kit for direct labelling of a PSMA-targeting
molecule with 68Ga. The kit utilises proprietary chemistry to enable robust and
reliable radiolabelling at room temperature in less than 5 minutes. ANMI's PSMA-
11 kit is currently under clinical development in Europe.4

1 Either directly with ANMI or in cooperation with ANMI's network of global
distribution partners
2 J Nucl Med 2017; 58:67S-76S - DOI: 10.2967/jnumed.116.186767
3 Prostate Cancer Foundation (PCT): https://www.pcf.org/c/about-the-prostate-
cancer-foundation/
4 None of ANMI or Telix's products currently have marketing authorization in the
US, EU or any other territory.

Investor and Media Contacts:

Telix Pharmaceuticals Limited
Kyahn Williamson
Head of Investor Communication
WE Buchan
(at): kwilliamson(at)buchanwe.com.au

ANMI SA
Ludovic Wouters
CEO
ANMI SA
lwouters(at)anmi.be




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Telix Pharmaceuticals Limited via GlobeNewswire




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Datum: 24.10.2017 - 01:00 Uhr
Sprache: Deutsch
News-ID 564832
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