GlobeNewswire

Drug Master File for Prostate Imaging Product Filed with the FDA

Dela

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.


Important Information

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.

____________

1 http://www.ezag.com

2 http://www.isotope-technologies-munich.com

3 http://www.ire.eu/

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: chris@telixpharma.com

Investor and Media Relations

Kyahn Williamson
WE Buchan 
Tel: +61 (3) 9866 4722
Email: kwilliamson@buchanwe.com.au 



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

Om

GlobeNewswire



Följ GlobeNewswire

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från GlobeNewswire

Iconovo: kundprojekt blir framflyttat tre till sex månader8.11.2018 15:45Pressmeddelande

Fortsatt arbete med ett av Iconovos pågående kundprojekt kommer att flyttas fram tre till sex månader. Projektet avser utveckling av produkt anpassad för kund som ska svara för produktion och marknadslansering. Det aktuella arbetet var planerat att ske under fjärde kvartalet men beräknas ske under nästa år, och detta påverkar Iconovos omsättning under 2018 negativt med cirka 2 miljoner kronor. Orsaken är att kunden har beslutat att genomföra en mindre klinisk studie för att verifiera produkten innan nästa steg tas vilken omfattar investeringar i betydande mångmiljonbelopp i produktionskapacitet, baserat på Iconovos utveckling. Studien görs för kundens egna räkning och är inte villkorad av tillsynsmyndigheter. "Detta påverkar vårt resultat på kort sikt, men det faktum att kunden har beslutat att göra en betydande investering i faktisk produktion betyder att vi med stor säkerhet kan se fram emot licensintäkter under en lång tidsrymd framöver i samband med att produkten lanseras på markna

Stillfront Group AB: Inbjudan till Stillfront Groups kvartalsrapport för tredje kvartalet 20187.11.2018 14:34Pressmeddelande

PRESSMEDDELANDE 7 november 2018 Inbjudan till Stillfront Groups kvartalsrapport för tredje kvartalet 2018 Stillfront Groups kvartalsrapport för det tredje kvartalet 2018 kommer att publiceras klockan 07.00 den 22 november 2018. En webbsänd telefonkonferens kommer att hållas klockan 10.00 samma dag där Jörgen Larsson, VD och Sten Wranne, CFO, kommenterar resultatet. Presentationen och rapporten kommer efter presentationen att finnas tillgänglig på www.stillfront.com Webbsändningen nås på adressen: https://tv.streamfabriken.com/stillfront-q3-2018 För att delta via telefon, vänligen ring: SE: +46 8 566 426 63 UK: +44 20 300 898 01 US: +1 8 557 532 235 FÖR YTTERLIGARE INFORMATION, VÄNLIGEN KONTAKTA: Sofia Wretman, IR Phone: +46 708 11 64 30 sofia@stillfront.com OM STILLFRONT Stillfront är en oberoende utvecklare, förläggare och distributör av digitala spel - med visionen att bli en ledande indie-spelutvecklare och förläggare. Stillfront är verksamt genom tio näst intill självständiga dotte

Stillfront Group AB: Invitation to Stillfront Group Q3 presentation7.11.2018 14:34Pressmeddelande

Invitation to Stillfront Group Q3 presentation Stillfront Group interim report for the third quarter 2018 will be published at 07.00 CET on 22 November 2018. A presentation of the report will be held the same day at 10.00 CET via telephone conference or audiocast where Jörgen Larsson, CEO and CFO Sten Wranne are to comment on the report. The presentation can be viewed live at https://tv.streamfabriken.com/stillfront-q3-2018 To participate via phone please call: SE: +46 8 566 426 63 UK: +44 20 300 898 01 US: +1 8 557 532 235 FOR FURTHER INFORMATION, PLEASE CONTACT: Sofia Wretman, IR Phone: +46 708 11 64 30 sofia@stillfront.com ABOUT STILLFRONT Stillfront is a group of independent creators, publishers and distributors of digital games - with a vision to become the leading group of indie game creators and publishers. Stillfront operates through ten near-autonomous subsidiaries: Bytro Labs in Germany, Coldwood Interactive in Sweden, Power Challenge in the UK and Sweden, Dorado Online Games

Modus Therapeutics announces FDA Acceptance of Sevuparin IND for the treatment of sickle cell disease7.11.2018 08:30Pressmeddelande

STOCKHOLM, November 7, 2018. Karolinska Development's portfolio company Modus Therapeutics announces today that the U.S Food & Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application to initiate a Phase I clinical trial with subcutaneous sevuparin for the treatment of sickle cell disease (SCD) FDA has decided to accept Modus Therapeutics' IND application of sevuparin for the treatment of SCD. Sevuparin is an innovative, proprietary modified polysaccharide drug with anti-adhesive, anti-aggregate and anti-inflammatory effects due to its multimodal mechanism of action. It has the potential to restore blood flow and prevent further microvascular obstructions in children and adults with SCD. At present, sevuparin is being evaluated as an intravenous infusion in a Phase II study in SCD patients with ongoing painful crises (also called vaso occlusive crises, VOC). In order to broaden the clinical scope and utility of sevuparin in the treatment of SCD, t

Modus Therapeutics announces FDA Acceptance of Sevuparin IND for the treatment of sickle cell disease7.11.2018 08:30Pressmeddelande

STOCKHOLM, November 7, 2018. Karolinska Development's portfolio company Modus Therapeutics announces today that the U.S Food & Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application to initiate a Phase I clinical trial with subcutaneous sevuparin for the treatment of sickle cell disease (SCD) FDA has decided to accept Modus Therapeutics' IND application of sevuparin for the treatment of SCD. Sevuparin is an innovative, proprietary modified polysaccharide drug with anti-adhesive, anti-aggregate and anti-inflammatory effects due to its multimodal mechanism of action. It has the potential to restore blood flow and prevent further microvascular obstructions in children and adults with SCD. At present, sevuparin is being evaluated as an intravenous infusion in a Phase II study in SCD patients with ongoing painful crises (also called vaso occlusive crises, VOC). In order to broaden the clinical scope and utility of sevuparin in the treatment of SCD, t

Oboya participates in China International Import Expo1.11.2018 15:00Pressmeddelande

Newsletter Lerum, 1th November 2018 Oboya Horticulture Industries AB (publ) ("Oboya"), a global manufacturer and supplier of products and services for the cultivation industry, will participate in China International Import Expo in Shanghai, China. China International Import Expo (CIIE) is a six-day fair held from November 5 to November 10, 2018 at the National Convention & Exhibition Center in Shanghai, China. This fair brings together companies, exhibitors and professional buyers from all over the world. The fair creates new channels for companies from different countries and regions and provides the opportunity to do business, strengthen cooperation and promote trade. Oboya's strategy is to work globally in the various markets in the cultivation and flower industry, which it's important for Oboya to participate in the major trade shows. Oboya has its own booth at the fair and will show/marketing the European cultivation products and technology to the Chinese market. The purpose of t

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum