ILLUCCIX & GOZELLIX (Telix) versus PYLARIFY (Latheus)Covering;
- Half lives & Shelf lives
- Image acquisition timeframes
- What management of Lantheus are saying about perceived logistics advantages
- How Cu64 solves problems highlighted by Lantheus
ILLUCCIX & GOZELLIXPer product labels (FDA);
- Gozellix allows for an extension of the Ga68-PSMA-11 product shelf-life by 2 hours (from 4 to 6 hours) - as shown below.
- The image acquisition timeframes are identical.
The radiolabelling of Illuccix and Gozellix is still done at Radiopharmacies (like Cardinal), after which the product must be transported to the hospital that needs it.
Questions: How far can it reach? How much radiation activity will the product have at later time points? How good is image quality, if used at later time points? Whats the sensitivity when used that late?
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PYLARIFY (LANTHEUS)- Pylarify has a shelf-life of 10 hours (longer than tha max that Gozellix allows
Pylarify is produced in cyclotrones and its half life does allow some shipments to reach some places that do not have a cyclotrone! But Pylarify is still limited - the half life is 110 minutes, and its shelf life is 10 hours.
But, even with the shelf-life that is longer than that for Illuccix and even Gozellix, the Lantheus management have bemoaned the challenges with trying to get the product to where its needed! Here are some quotes from the Lantheus management in the recent calls - highlighting some strengths as well as some weaknesses;
- On Central production: “Our radiopharmacy network and central manufacturing model are key enablers of our commercial success.” (Brian Markison, CEO, Q4 2024)
- On reliable deliveries: “We continue to see broad demand for Pylarify across both large institutions and regional imaging centers, driven by our ability to reliably meet delivery expectations.” (Paul Blanchfield, President, Q1 2025)
- On the regional/rural gap: “Growth is particularly strong among smaller and mid-sized centers that previously struggled with access to PSMA PET imaging.” (Amanda Morgan, CCO, Q1 2025)
- On half-life enabling manufacturing leverage: “We have a longer half-life… a distribution advantage… enables us to optimize our multi-partner manufacturing facility network.” (Amanda Morgan, Q4 2024)
- Admission: Pylarify can’t always show up on time: “There are select markets where there is limited access to Pylarify in early mornings or late afternoon.” (Amanda Morgan, CCO, Q4 2024)
CLARITY'S 64Cu-Sar-bisPSMA- If a longer half-life is an advantage (as Lantheus are saying), then Cu-64 has a a lot of it!
- If a longer shelf-life is an advantage (as Telix appear to be indicating) then, Cu-64 has a a lot of it!
- If centralized manufacture and distributiois an advantage (as Lantheus are saying), then Cu64 is suitable for it, with no need for hot labs everywhere.“Red-eye flights replace radiopharmacies.”
- Unlike Pylarify, previous day delivery of Cu64 products means that patients can be scheduled for morning, afternoon, or even next-day.
- More and more sites and towns that don't have in-house radiochemistry can receive product by plane and/or courier!
All before the case of speriority - which is not guaranteed, but indications suggest will be achieved!
FDA Approval is not guaranteed either, but lessons from other approvals suggest that, on efficacy and safety, this product will pass!
FURTHER READING
NDA Multi-Disciplinary Review and Evaluation - NDA 214032 Gallium Ga 68 PSMA-11 Injection.pdfGozellix Label.pdfNDA Multi-Disciplinary Review and Evaluation - NDA 212643, Gallium Ga 68 PSMA-11 Injection.pdfPylarify label.pdfIlluccix label.pdfPylarify FDA revew.pdf
(20min delay)