Manufacturing News

Telix Pharmaceuticals offers prostate cancer imaging solution to US

Telix Pharmaceuticals has submitted a Drug Master File (DMF) to the US Food and Drug Administration for a sterile kit used in the detection of prostate cancer.

The 68Ga-PSMA-11 (PSMA Kit) is as a promising diagnostic method for patients with suspicion or history of prostate cancer.

The filing of this DMF is an important step toward offering a commercial prostate-specific membrane antigen-based imaging solution for the US market, Telix USA president Dr Bernard Lambert said.

Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products. The company is based in Melbourne, but conducts R&D, clinical and commercial activities in Australia, USA, Germany, UK and France via its holding company.

From a scientific perspective, it focuses on products based on targeted radiopharmaceuticals or molecularly-targeted radiation.

Telix Pharmaceuticals has achieved this accomplishment in collaboration with ANMI, a Belgium-based precursor supplier for radiometal labeled radiopharmaceuticals.

“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,” Dr Lambert said.


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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, a joint venture company between Telix Pharmaceuticals (US) and ANMI.

There would appear to be a large and growing market for this type of product.

Prostate cancer has emerged as the number one cancer killer in the United States, with around 160,000 new cases annually, and 3 million men with prostate cancer.

There is a major unmet need to better diagnose and stage men with prostate cancer, from initial diagnosis through to therapeutic monitoring of late-stage metastatic disease.

The prostate imaging market in the US is valued at about US$500 million (AU$645 million).

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