Extract from Bell Potter Research report just issued.
FDA keen to get PI-88 approved
The Fast Track program was designed to facilitate the development and expedite the regulatory review of new drugs that demonstrate the potential to treat serious or lifethreatening diseases where there is an unmet medical need. We expect that the FDA has reviewed the clinical trial data for PI-88 and sees its potential as a treatment for postresection primary liver cancer patients.
What happens after a drug is awarded Fast Track?
There are two regulatory paths available. Ordinarily, a drug in the Fast Track program will be eligible for accelerated approval or priority review once the Phase 3 trial data has been submitted to the FDA.
Accelerated approval allows the drug to become approved based on preliminary evidence that is considered likely to predict patient benefit. The approval that is granted may be considered a provisional approval however the drug would be available on the market and the company would need to complete clinical studies that formally demonstrate patient benefit.
Priority review ensures the FDA provides its decision on the approval application within 6 months. Drugs submitted for approval are often designated Standard or Priority. Under Standard designation, the FDA has 12 months to make a decision. In our view, accelerated approval is a likely outcome for PI-88 given PGL expects to get the drug approved based on the alternative endpoint - disease-free survival ( the length of time after treatment that a person experiences a complete remission, i.e. cancer is not detectable in the body). Traditionally, cancer drugs are approved based on overall survival endpoints.
PI-88 awarded US FDA Fast Track status
Fast Track status replaces SPA
We believe the FDA has approved the Phase 3 trial design by awarding PI-88 with Fast Track status. Given PGL’s intentions to proceed to a Phase 3 trial, the FDA would have reviewed the Phase 3 trial design and agreed upon the two key issues - patient sample size and disease-free survival as the primary endpoint. We expect PGL to commence the trial before year-end and achieve full recruitment (600 patients) by 3Q 2008.
Fast Track status adds significant value for potential commercial deal
Fast Track status clearly bodes well for a potential partner interested in co-developing or in-licensing PI-88. In addition, more than 95% of cancer drugs that have been approved under the accelerated approval or priority review program were developed by a large pharmaceutical company. Although PI-88 is yet to gain this status, we continue to believe PGL is likely to sign a deal to further commercialise PI-88.
PGL Price at posting:
0.0¢ Sentiment: Buy Disclosure: Held
