Telix Pharmaceuticals (ASX:TLX) has announced an agreement with contract development and manufacturing organisation Grand River Aseptic Manufacturing (‘GRAM’) to perform commercial-scale manufacturing of its Illuccix product.
Telix is a clinical-stage biopharmaceutical company developing diagnostic and therapeutic products using Molecularly Targeted Radiation. The company is headquartered in Melbourne with international operations in Belgium, Japan, and the US.
Illuccix (TLX591-CDx, Kit for the preparation of 68Ga-PSMA-11) is used 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 the US for that market, Canada, the European Union and Australia.
Telix Americas President Dr Bernard Lambert said, “With commercial distribution agreements in place with major radiopharmacy networks covering over 90% of the US 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 US 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 honour 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.”