Bionichehas three businesses with diversified risk/reward profiles:AnimalHealth, which is expected to generate around $28 million in salesinfiscal 2010; Human Health, with Phase 3 results expected in mid-2010from lead product, Urocidin, testing for bladder cancer; and FoodSafety,with Canadian approval and a conditional license pending in theU.S. of avaccine for reducing E. coli 0157 in cattle feces, and apipeline ofother vaccines.
Mr. Martin points out that Urocidin provides the“biggest upside potential” for Bioniche investors. His initial diligencesuggests that Urocidin has a “relatively high overall probability ofapproval,” eventhough the first of two planned Phase 3 trials has amoderate level ofrisk, as the refractory patients enrolled in the trialare a“tougher-to-treat” population than was enrolled in the Phase 2trial, hesays.
Mitigating the risk somewhat is the 20% “completeresponse” hurdlerequired for Phase 3. That compares with the company’sPhase 2 results,where patients achieved a 46.4% CR rate at 26 weeks in apopulation thatwas mainly relapsed but also included a few patientsbeing treated forthe first time.
A second planned Phase 3 trialwill test Urocidin head-to-head againstthe current standard of care,baccilus Calmette-Guerin (BCG) infirst-line treatment, “where we expectUrocidin to demonstrate betterefficacy, based on prior data, andsuperior safety and tolerability,” hepredicts.
In 2009, Bionichelicensed Urocidin’s U.S. commercial rights to EndoPharmaceuticals. Basedon incidence of bladder cancer and possiblepricing, he figures theglobal market opportunity for Urocidin in therefractory population couldbe $800 million. If the second Phase 3 trialexpands the Urocidin labelto first-line treatment, the marketopportunity could grow to anestimated $2 billion.
“Twenty-five percent penetration of thismarket would represent $500million in annual sales and an estimated$112.5 million in gross profitfor Bioniche,” Mr. Martin says .
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Chief Medical Officer exercise his option for 130000$ =MEANS HE KNOWS THAT PHASE 3 RESULTS IS VERY GOOD !!!
FilingDate Transaction Date Insider Name Ownership Type Securities Nature oftransaction # or value acquired or disposed of Unit Price
Sep 20/10 Sep 20/10 Charette, Francois Guy Direct Ownership Common Shares 51 - Exercise of options 50,000 $1.100
Sep 20/10 Sep 16/10 Charette, Francois Guy Direct Ownership Common Shares 51 - Exercise of options 80,000 .90
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