Oncology-focused drug development company Kazia Therapeutics has successfully patented the manufacturing process for paxalisib in India and the United States.
Paxalisib is a brain-penetrant inhibitor which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults.
The Sydney-based company – which awaits the grant of a similar patent in Australia – said the newly granted manufacturing patents by the respective agencies of the US and India expire in 2036 and provide an additional layer of protection by covering the process by which paxalisib is manufactured.
According to the company’s CEO, Dr James Garner, any generic competitor would need to develop an alternative method of chemical synthesis, which is technically challenging and hence a costly exercise.
“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,” Mr Garner noted.
“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.”
According to the company’s statement, further patents remain pending in the EU, China, Canada, and other strategic territories and are expected to be approved in due course.