What they said a long time ago... -- Nov 2007
www.bioniche.com/presentations/BLSI-AGM-11.08.07.ppt
About probability of success:
30% failure in Phase I
52% failure Phase II
10% failure Phase III
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About the trial:
FIRST TRIAL (protocol approved by FDA, Health Canada):
•105 patients
•North America
•Open-label trial showing the efficacy of Urocidin as therapy in non-invasive bladder cancer refractory (unresponsive) to Bacillus Calmette-Guérin (BCG).
•Goal: show that Urocidin can result in complete response in up to 40%* of patients sustained at one year, and that less than 10% of patients are unable to tolerate treatment.
*BCG + Interferon has a 20% response rate with side effects
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About the Timeline:
•We need to recruit 105 “eligible and evaluable” patients and follow them for one year to obtain efficacy data to present to the FDA. This is expected to be completed by mid-2009.
•We anticipate that we will have additional safety data generated as we recruit patients into the comparative trial (early 2008).
•Both efficacy and safety data are necessary for a registration that (fast tracked) could mean market launch of the refractory indication by late 2010/2011.
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About partenering:
•Bioniche preference for deal terms:
–Up-front cash
–Commitment to fund Phase III clinical program
–Retention of manufacturing
–Profit sharing/royalty stream on product sales (ideally 20%+)
–Partnership deal on a Phase III product has 85% probability of getting product to market (vs. Phase I deal – 2% probability of reaching market).
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About the market (for first indication of Urocidin)
US: First line therapy failure : 70 million, European Union : 150 million
US : Intermediate to high risk : 230 million, EU: 500 million
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About sales
200$ million for 90% of all new drugs