Benzinga | Jun 24, 2021 06:05AM EDT

Kazia Therapeutics Announced Manufacturing Patents Granted for Paxalisib in Key Territories; Extend Effective Patent Protection to 2036

Kazia Therapeutics Limited (NASDAQ:KZIA) is pleased to announce the grant of patents by the respective agencies of the United States and India in respect of the manufacturing process for paxalisib. A similar patent has been accepted in Australia and is expected to proceed to grant in 3Q CY2021. Further patents remain pending in the EU, China, Canada, and other strategic territories and are expected to also be approved in due course.

Key Points Existing composition of matter' patents for the chemical structure of paxalisib generally expire in 2031 but are likely to be eligible for a five-year patent term extension in key territories. These newly granted manufacturing patents provide an additional layer of protection by covering the process by which paxalisib is manufactured. Any generic competitor would need to develop an alternative method of chemical synthesis, which is technically challenging and hence a costly exercise. The new patents expire in 2036. Kazia CEO, Dr James Garner, commented, "as we move towards commercialisation, we have worked closely with our IP counsel to ensure we achieve the maximum possible degree and duration of protection for the intellectual property embodied in paxalisib. The original patents for paxalisib protect its chemical structure and have been granted in almost all relevant territories. The new suite of patents additionally covers the process by which paxalisib is manufactured and, together with the original composition of matter patents, provide exceptionally robust protection. The manufacturing patents are now granted in the US and India, and are also expected to be granted in other key territories after review by the respective patent agencies."

Next Steps GBM AGILE, the pivotal study for registration of paxalisib, is currently underway in the United States and is expected to open in Europe during 2H CY2021.