Telix Pharmaceuticals and Grand River Aseptic Manufacturing Complete Agreement for Commercial Manufacturing of Illuccix®
MELBOURNE, Australia and INDIANAPOLIS, March 30, 2021 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces today that it has completed an agreement with contract development and manufacturing organisation (CDMO) Grand River Aseptic Manufacturing (‘GRAM’) to perform commercial-scale Good Manufacturing Practice (GMP) manufacturing of Telix’s Illuccix® product (TLX591-CDx, Kit for the preparation of 68Ga-PSMA-11) for prostate cancer imaging.
Under the terms of the Agreement, GRAM will perform advanced aseptic fill and finish services for Illuccix® at its facilities in Grand Rapids, (Michigan, U.S.A.) for the U.S., Canada, EU, and Australian markets.
Telix Americas President Dr. Bernard Lambert stated, “With commercial distribution agreements in place with major radiopharmacy networks covering over 90% of the U.S. population, we are pleased to have entered this agreement with GRAM, thus delivering a key component of our manufacturing and supply chain strategy for GMP manufacturing of Telix’s first commercial product. As we prepare for the U.S. launch of Illuccix® it is especially reassuring to know that, subject to approval by the FDA, supply will originate from a site in Michigan, providing certainty of access for American men living with prostate cancer.”
GRAM President and CEO Tom Ross added, “We wish to congratulate Telix on reaching this incredible milestone. It is a great honor to support pharmaceutical innovators with fill and finish services as they work to deliver novel drug products to market. GRAM’s partnership with Telix is founded on deep technical expertise and shared values that are backed by a strong quality record, world class equipment and passionate team members. I look forward to all we will accomplish together.”
About Telix Pharmaceuticals Limited
Telix is a clinical-stage biopharmaceutical company developing diagnostic and therapeutic products using Molecularly Targeted Radiation. Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.
Telix’s lead product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA1, and has been granted Priority Review status by the Australian Therapeutic Goods Administration (TGA).2 Telix is also progressing marketing authorisation applications for Illuccix® in the European Union3 and Canada.4 None of Telix’s products have currently received a marketing authorisation in any jurisdiction.
About Grand River Aseptic Manufacturing, Inc.
Grand River Aseptic Manufacturing, Inc. (‘GRAM’), a leading parenteral contract development and manufacturing organization, delivers customized solutions to meet clients’ fill and finish needs from development through commercialization. With capabilities for biologics as well as controlled substances, GRAM’s advanced technology and staff supports pharmaceutical development and cGMP manufacturing, analytical testing, and regulatory filing.
1 ASX disclosure 24/11/2020.
2 ASX disclosure 7/12/2020.
3 ASX disclosure 1/05/2020.
4 ASX disclosure 16/12/2020.