ASX-listed Clarity Pharmaceuticals has signed a Master Service Agreement and a Clinical Supply Agreement with Siemens Healthineers company PETNET Solutions Inc for the supply expansion of Clarity’s 64Cu SAR-bisPSMA, a diagnostic radiopharmaceutical product for prostate cancer imaging.
In a media release, Clarity said radiopharmaceuticals developer PETNET Solutions will manufacture ready-to-use 64Cu SAR-bisPSMA for US-based clinical trials under the Clinical Supply Agreement in accordance with current Good Manufacturing Practise (cGMP) criteria.
In particular, 64Cu SAR-bisPSMA is an investigational PET agent that is expected to begin a pivotal Phase III trial in the United States by the end of 2023, with a potential second Phase III trial in 2024.
On the other hand, the firms’ Master Services Agreement will allow for the expedited technology transfer of other Cu-64-based imaging agents from Clarity to the PETNET Solutions network in the United States for current and future clinical trials.
Dr Alan Taylor, Clarity’s executive chairman, expressed his excitement to be collaborating on the company’s 64Cu SAR-bisPSMA product with the largest PET manufacturing network in the US.
“The prostate cancer market is one of the largest in oncology, and the growing US market for PSMA PET diagnostics is anticipated to generate sales of US$1.0 Billion during 2023,” Dr Taylor remarked.
He added, “We are looking forward to commencing our registrational Phase III trials with PETNET Solutions and elucidating the many benefits of 64Cu SAR-bisPSMA to bring this next-generation PSMA-PET diagnostic to prostate cancer patients around the world.”
Meanwhile, Barry Scott, CEO of PETNET Solutions, said the company is thrilled to work with Clarity to supply 64Cu SAR-bisPSMA for their Phase III clinical trials.
“With the right experience and network to help ensure that the Phase III clinical trials run seamlessly, we look forward to bringing 64Cu SAR-bisPSMA to prostate cancer patients, with the shared goal of improving treatment outcomes,” Scott noted.
Both the Clinical Supply Agreement and the Master Service Agreement take effect on 13 June 2023.
Before the end of the calendar year 2023, PETNET Solutions is anticipated to deliver the initial supply.
The Clinical Supply Agreement has a three-year starting term, whereas the Master Services Agreement has a five-year initial term.
