12 PIPELINE REVIEW in areas such as manufacturing, where we look to tie down the final commercial process, and in drug safety, where we have begun to pool all the vast collection of safety data from the many clinical studies of paxalisib that have been and are being performed. The final NDA submission will consist of many thousands of pages of narrative and data. An NDA approval allows Kazia, either directly or through licensees and distributors, to begin selling paxalisib commercially. We have invested substantial work in the past year to explore brain cancer as a commercial market, with the support in some areas of specialist consultants in drug commercialisation. What we have learned has been tremendously encouraging. For example, presented with the profile of a drug such as paxalisib, US prescribers estimate that they would use it for between 84% and 94% of newly diagnosed patients. This is an extraordinary adoption rate. And discussions with payors suggest that pricing for paxalisib should be comparable to some of the most successful cancer drugs launched in recent years. Clearly, the global commercial launch of a drug such as paxalisib is beyond the remit of a small company such as Kazia. We have always been clear that we expect to work with partners to bring the drug to market around the world. We took the first step in that journey in March 2021, when we licensed the Greater China region to Simcere Pharmaceutical, a leading Chinese pharma company. Simcere have proven themselves to be an excellent partner, and their expertise and resources have greatly expedited the entry of paxalisib into China. It is likely that similar partnerships will support the commercialisation of paxalisib in other territories. Kazia would be foolhardy to try and launch a drug itself in Japan or in Latin America, for example. The timing of such partnerships is always a balance. Waiting until final data is available typically allows for the most lucrative deal. However, partnering earlier can allow the company to share risk and cost with its partners, and can also provide access to in-country expertise. The latter point was a critical consideration for Kazia’s partnership with Simcere, given the complexity of the Chinese market. It is not inconceivable that Kazia could consider launching paxalisib in the United States itself. The US market typically accounts for 45-50% of the commercial value of a new cancer drug, and there is an economic argument in favour of retaining that value within Kazia. Glioblastoma is a specialist disease area, in which patients are cared for by a relatively small group of clinicians, and it would not require a large commercial infrastructure to support a product launch. Ultimately, our approach, as in all matters, will be governed by pragmatism, but we are in the fortunate position of having several compelling approaches to consider. PAXALISIB CLINICAL PROGRAM Sponsor Phase Indication Registration Global Coalition for Adaptive Research II / III Glioblastoma NCT03970447 Weill Cornell Cancer Center II Glioblastoma (with ketogenic diet + metformin) NCT05183204 Alliance for Clinical Trials in Oncology II Brain metastases NCT03994796 Dana-Farber Cancer Institute II Breast cancer brain metastases (with trastuzumab) NCT03765983 Dana-Farber Cancer Institute II Primary CNS lymphoma NCT04906096 Pacific Pediatric Neuro Oncology Consortium II DIPG & DMGs NCT05009992 St Jude Children’s Research Hospital I DIPG (childhood brain cancer) NCT03696355 Memorial Sloan Kettering Cancer Center I Brain metastases (with radiotherapy) NCT04192981
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