Someone bought 55k after Hour at 1,78$ on OTC .POSITIVE PHASE 3 RESULTS FOR UROCIDIN (BLADDER CANCER VACCINE) COMING .THIS NEWS WILL PUSH THIS STOCK TO 6-8$ EASILY .BNC.TO IS STILL A FANTATSIC BUYING OPPORTUNITY .
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Good link for Investors or Newbies
http://www.stockhouse.com/Bullboards/MessageDetail.aspx?s=BNC&t=LIST&m=28707027&l=0&pd=0&r=0
AusBiotech2010
19 to 22 October 2010
http://ausbiotech2010.com.au/uploads/Program/Graeme%20McRae.pdf
UPCOMING MILESTONES 2010 <<<< THE MOST IMPORTANT YEAR IN THE HISTORY OF BIONICHE
UROCIDIN PHASE 3 RESULTS << MONSTER SP DRIVER
ECONICHE USDA APPROVAL <<ANOTHER BIG SP DRIVER
BIONICHE – BLADDER CANCER UPSIDE, BASE BUSINESS PROTECTS DOWNSIDE
Bioniche has 3 businesses with diversified risk/rewardprofiles: 1)AnimalHealth, which is expected to generate $27-$28 million insales infiscal2010; 2) Human Health, with lead product, Urocidin, in Phase3testing forbladder cancer (results expected mid-2010); 3) Food Safety,withanapproved (in Canada) vaccine for reducing E. coli 0157 in cattle*****(U.S.conditional license pending) and a pipeline of othervaccines. Thecommonelement linking most of the company’s products anddevelopmentprograms isimmune stimulation.
Animal Health
We view Animal Health as a stable business and a value backstop forthehigher risk/rewardopportunities. Our estimated F2010 sales of$27-$28million would be lower Y/Yvs F2009 (sales $33 million) due mainlytoforeign exchange impact and softnessin some end markets due totheeconomic turndown. However, 2011 could be abetter year with theeconomyrecovering and potential for geographic expansionof Folltropin.
Urocidin
Urocidin (Mycobacterial Cell Wall-DNA Complex, or MCC)providesthebiggest upside potential forBNC investors, with Phase 3 resultsexpectedmid-2010. MCC is a DNA/proteinisolate fromnon-pathogenicmycobacterium, phlei. Its main action is tostimulatedirectpro-apoptotic and indirect immune-mediated killing of cancercellsinpatients with non-invasive bladder cancer.
Our initial diligence suggests that Urocidin has arelatively highoverallprobability of approval, although the first of twoplanned Phase 3trialshas a moderate level of risk – the refractory patientsenrolledin thefirst Phase 3 are a “tougher-to-treat” population thanwasenrolled inPhase 2. Mitigating the risk to a degree, is the 20%completeresponse(CR) hurdle for Phase 3 – in Phase 2, patients achieveda 46.4% CRrate at26 weeks in a population that was mainly relapsed,but also includedafew naïve patients (Figure 8).
Figure8: Urocidin Phase 2 Complete Response Rate (%)
Week12 Week 26 Month 12Month 18 (for MCC 4 mg / MCC 8 mg)
27 / 46 27/ 46 32 / 64 23 / 73 (rounded %ages)
A second planned Phase 3 trial will testUrocidin head-to-head againstthecurrent standard of care, baccilusCalmette-Guerin (BCG) infirst-linetreatment, where we expect Urocidin todemonstrate betterefficacy basedon prior data, and superior safety and tolerability– BCGis a livepathogen, carrying with it risk of contamination,fatalinfection andfrequent painful bladder inflammation.
In July 2009, Bioniche licensed U.S. Urocidincommercial rights toEndoPharmaceuticals (ENDP-Q; unrated). Bioniche receivedan up-frontcashpayment of $20 million with the potential for as much as $110millioninadditional payments based on future clinical, regulatory,andcommercialmilestones. Subsequently, in February 2010, Endo exercisedan optiontolicense the remaining global commercial rights for Urocidin,payingBionichea further $8 million, and taking on the remaining Phase3development costs.Bioniche will manufacture the product and receiveatransfer price for supply.After COGS, we estimate the net toBionichewill be approximately 20%-25% ofsales. Bioniche currentlyoperates acGMP facility capable of manufacturing~35,000 Urocidin dosesannually,with plans to build a million dose facility ata cost ofapproximately$30 million (planned funding to be provided bygovernmentloans andgrants) contingent on success of the upcoming Phase 3trial.
Bladder cancer is the fourth most common cancer in men,and the ninthmostcommon in women. About 500,000 people in the U.S. currentlyhavebladdercancer, and the number of new cases each year is about 70,000(ofwhich50,000 have the non-muscle invasive form of the cancer thatiseligiblefor Urocidin treatment). Two thirds of patients (33,330)typicaldo not respondto BCG or relapse within a year. Globally, itisestimated that 80,000 bladdercancer patients become refractoryeachyear.
Based on these estimates, the global market opportunityfor Urocidininthe refractory population would be $800 million – this assumesa perdosecost of $1,000 ($21,000 for a full course of 21 doses, supportedbythe$22,000 cost for a full course of Valstar), and assumesthateachrefractory patient receives an average of 10 doses (based on25%receiving afull course and 75% receiving only the first 6inductiondoses). If the secondPhase 3 trial expands the Urocidin labelto firstline treatment, the marketopportunity would grow to theestimated 2million doses of BCG sold globallyeach year, or $2 billion.25%penetration of this market would represent $500million in annualsales,and an estimated $112.5 million in gross profit forBioniche.
Food Safety
Food Safety, the third Bioniche business, is primarilyfocusedondevelopment and commercialization of a vaccine for cattlewhichlowersthe fecal load of pathogenic 0157 E. coli bacteria. Theproductislicensed in Canada,where the primary market, upscale cattlefarms, isvery small. The company ishopeful it will receive conditionalapprovalto sell the vaccine in the U.S. this year,where there are manymorecattle farms, and a higher percentage (20% vs. 2%bymanagement’sestimate) produce upscale, branded beef.
Near-term Hurdle for Value Inflection
The key hurdle for BNC value inflection will be Phase 3Urocidinresultsexpected mid-2010. We believe there is a moderate-to-goodchanceofsuccess for this trial, and we believe with the baseAnimalHealthbusiness, that downside risk is limited.
Key risks:
Clinical risk –While we believe Urocidin has demonstratedstrongindications of superiority(safety and efficacy) vs BCG in priorclinicaltesting, the hurdle is high forthe upcoming results for thefirst Phase3 trial for the bladder cancer drug.Mitigating this risk isthe basebusiness of Bioniche, the deep-pocketedpartner for Urocidin, andourview that the long term probability of approvalof the drug is high.
Urocidin pricing - The expected pricing for Urocidin (~$1,000 perdose)is substantiallyhigher than for BCG (~$50 per dose). We believehigherpricing can bejustified, but it will be necessary to continuetodemonstrate substantialefficacy and safety benefits in Phase 3.
Base business risk - The base businessis on track for lower salesinF2010 vs F2009. F2011 may see an uptick on theback of bettereconomicgrowth and specific Animal Health product initiatives,and webelieveUrocidin will be the bigger driver of BNC stock in the nearterm.
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