Drug Master File for Prostate Imaging Product Filed with the FDA
MELBOURNE, Australia and INDIANAPOLIS, March 26, 2018 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX.TLX) ("Telix Group", "Company"), a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or "molecularly-targeted radiation" (MTR), has today announced the submission of a Drug Master File (DMF) for a sterile kit used in the preparation of 68Ga-PSMA-11 (PSMA Kit), to the US Food and Drug Administration (FDA DMF ID: 032631).
Dr. Bernard Lambert, President of Telix USA noted, "The filing of this DMF marks an important step toward offering a commercial PSMA prostate imaging solution for the US market, and we are the first to have achieved this accomplishment in collaboration with our partner, ANMI. There is considerable demand for effective prostate imaging in the United States and we already have several leading cancer hospitals preparing to use the PSMA Kit. We'd also like to acknowledge the excellent work of our colleagues at NukeMed and the team at Indiana University, who worked tirelessly over the past six months to complete the validation work."
The PSMA Kit has been validated for use with all major vendors of 68Ga generators, including Eckert & Ziegler1, ITM2 and IRE ELiT3. The PSMA Kit is expected to be commercially available by mid-2018, subject to FDA review of the manufacturing package. The DMF is held by Kyzeo Imaging LLC (Kyzeo), a joint-venture company between Telix Pharmaceuticals (US) Inc. and ANMI SA.
About the US Prostate Cancer Imaging Market
Prostate cancer has emerged as a major cancer killer in the United States, with approximately 160,000 new cases annually and three million men living with prostate cancer.4 There remains a significant unmet need to better diagnose and stage men with prostate cancer, from initial diagnosis all the way to therapeutic monitoring in patients with late-stage metastatic disease. The prostate imaging market in the US is estimated to be a $500m market opportunity, likely to be dominated by the use of Positron Emission Tomography (PET) and imaging agents targeting prostate-specific membrane antigen (PSMA) in particular.5
About Telix Pharmaceuticals Limited
Telix Pharmaceuticals Limited (Telix Group, Telix) is a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or "molecularly-targeted radiation" (MTR). The company is headquartered in Melbourne with international operations in Brussels (EU), Kyoto (JP) and Indianapolis (US). Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in renal, prostate and brain (glioblastoma) cancer. Telix is listed on the Australian Securities Exchange (ASX:TLX). 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 high-performance radiopharmaceuticals through streamlined and cost-effective production processes. For more information visit www.anmi.be.
About Kyzeo Imaging, LLC
Kyzeo Imaging, LLC is US-based JV between ANMI and Telix USA (the US operating entity of Telix Group) to commercialize a sterile cold kit for the preparation of 68Ga-PSMA-11 for the imaging of prostate cancer with Positron Emission Tomography (PET). The commercial partnership is structured as a JV to support a profit-sharing arrangement between Telix USA and ANMI, and to support the use of the PSMA Kit in 3rd party clinical trials of novel prostate cancer therapeutics in a commercially arms-length manner from Telix Group. Telix USA is the exclusive distribution partner for the PSMA Kit in the US market.
This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933 (the "US Securities Act"), or under the securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States, unless the securities have been registered under the US Securities Act or an exemption from the registration requirements of the US Securities Act is available.
None of the products described in this release have obtained a marketing authorization from the US Food and Drug Administration.
4 American Cancer Society : https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
5 Jadvar et al. J Nucl Med February 1, 2018 vol. 59 no. 2 228-229
Corporate Contact Dr Christian Behrenbruch Telix Pharmaceuticals Limited CEO Email: firstname.lastname@example.org Investor and Media Relations Kyahn Williamson WE Buchan Tel: +61 (3) 9866 4722 Email: email@example.com
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
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