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Im new to this stock and it looks great. Im going to buy a bunch of shares this week. Does anyone know if BNHLF hired a independent company to conduct a analysis on potential annual sales ? If so what are the numbers?
Google translate on today's PR
Bioniche Life Sciences Inc. will release the full results of a clinical phase III study in The Journal of Urology
MONTREAL, Oct. 10, 2014 / CNW / -. Bioniche Life Sciences Inc. (TSX, BNC, KFN and BNHLF the TSX) today announced that The Journal of Urology has agreed to publish a manuscript document Efficacy and Safety in Patients with MCNA of Non-Muscle Invasive Bladder Cancer at High Risk of Recurrence-and progression Who Have Failed Treatment with Bacillus Calmette-Guerin. A full version of the article is now available online for review and citation at www.jurology.com (http://www.jurology.com/article/S0022-5347(14)04590-X/abstract) ; the printed version is tentatively scheduled for April 2015.
The data presented in this article refer to a study of phase III conducted on a complex cellular nucleic acid-wall mycobacterial (Mycobacterium phlei MCNA or cell wall-nucleic acid complex) and include the results of statistical analyzes required the end of the study, including the efficacy rate three months, six months and two years after treatment. Post-hoc analyzes were conducted to determine the effectiveness of MCNA in subgroups of patients in whom treatment with bacillus Calmette-Guerin (BCG) has failed, and treatment outcomes such as duration of response, the effect on disease progression and rates of cystectomy, are also presented. These analyzes complement the previous preliminary results of the study were presented in abstract form at the time of the Congress of Urology held in North America and internationally.
Commenting on the article, Dr. Michael Berendt, CEO and Chief Scientific Officer of Bioniche, said: "We are very pleased to present, for the first time, the world community urologists, a set of comprehensive data on our study of phase III which will underpin our license application for a biological product. We continue to believe that our flagship product, MCNA, meets a real unmet medical need in this population at high risk, underserved, that is refractory to current standard of care, treatment with BCG, and research treatments not surgery to avoid or delay cystectomy. "
The corresponding author of the paper and the principal investigator of the study based Phase III MCNA, Dr. Ashish M. Kamat, professor and surgeon holds the Urology Department / Division of Surgery and Director of postgraduate urologic oncology at MD Anderson Cancer Center at the University of Texas program, said: "The intravesical treatment with MCNA offers an alternative for patients in whom treatment with BCG has failed and who not want to undergo radical cystectomy. Since its mode of action is based on a combination of direct cytotoxic and immunological principles, the MCNA also has the potential to provide a sustainable response. "
been grabbing a little here lately under .21 when funds are available....should start heating up soon.....
Sujan, well detailed for independent analyst, many of his coverages have turned into multi-baggers. Waiting for Orphan Drug designation on BNHLF(within 60 days)
For anyone that has not read the recent article, you can read by clicking the link below:
http://seekingalpha.com/author/sujan-lahiri/instablog
GREAT ALERT FROM MY BOY ... SUJAN
$$ BNHLF $$
Quite an interesting company. Wish my stock screener would have thrown it at me last week, but then again, last week didn't have the sustained volume and move upward. The move back in July might have been too sharp for my tracker program to pick up on.
This is a review of Bioniche that provides some interesting reading.
Looks like I might just have to buy tomorrow as it looks like a very
good long-term trade.
Bioniche Seeking Alpha Post
BNC.TO (MC $40 M) BLA Filing in 1Q for Bladder Cancer vaccine
The Drug is effective and has great safety Profile and im sure it will work even on other types of cancer because Bladder Cancer is one of the hard to treat .. MarketCap of around $40 M (includes the current Share Offering) is very very cheap for a Biotech who has a big cancer Drug that completes all clinical studies successfully .
I think a price target of $2 within 12-18 months is realistic ....
Bioniche Life Science (BNC.TO) << Canadian Stock
Market Cap $40 M
Cash $15 M
Price $0.21
Bioniche Announces Q1/2015 Timeline for the Filing of a Biologics License Application for Marketing Approval of MCNA in the United States..
http://finance.yahoo.com/news/bioniche-announces-q1-2015-timeline-120000914.html
Latest Presentation
http://www.bioniche.com/pdf/2014/Bioniche%20Non-Conifidential%20Presentation%20June%202014.pdf
MCNA Phase 3 Study-Summary
Bioniche completed an open-label, single-arm Phase 3 trial with MCNA suspension.
Objective was to evaluate the efficacy and safety of MCNA in patients with
NMIBC at high risk of recurrence and progression who had failed BCG therapy
Total of 129 patients with high grade papillary and/or carcinoma insitu (CIS) who had failed (refractory or relapse) to respond to one or more courses of BCG were enrolled across 25 centers in U.S. and Canada
.
MCNA-Phase 3 Overview Strong Potential as Salvage Therapy
25% overall DFS rate at 1 year
35% DFS rate in patients with papillary tumors only at 1 year
Response to MCNA treatment provides several additional clinical benefits
•Based on post-study analyses benefits included:
•Long duration of response
•Reduced rate of cystectomies
•Reduced risk of progression
Excellent safety and tolerability profile
Most adverse events reported were mild to moderate in severity.
No special handling or disposal required
Market Potential
The Company has conducted an internal assessment of the potential available patients in the U.S. on a yearly basis, using a watershed/stratification of published NMIBC epidemiology data and guidance from urologists experienced in the treatment of the disease. Based on internal analyses, the Company projects that there are approximately 8,500 new available patients in the U.S. each year. Based on these patient number assumptions, and making certain estimates of drug pricing, unit volume and market penetration rates, the Company estimates that in the U.S. the market potential for MCNA in BCG-failures could approach $200 million per year. The Company is in the process of engaging an external firm with expertise in market research, commercial assessment and market access (pricing and reimbursement) in order to validate these internal estimates and obtain sales forecasts based on various commercial scenarios.
Read more at http://www.stockhouse.com/companies/bullboard/t.bnc/bioniche-life-sciences-inc#gExUb8gpcy8sdFJm.99
Is anything going on with this company?
Great Phase 3 results in Bladder Cancer
Bioniche(BNC.TO) and Endo Pharma with great results in Bladder cancer .
http://www.pharmaceutical-business-review.com/news/endo-pharma-bioniche-to-present-urocidin-phase-iii-trial-results-180211
Hi,
I bought this stock at $1.87 a few weeks ago and it has progressively gone down. Is it still worth keeping?
Thanks in advance
does anybody know when the phase III results will be posted? i thaught In October 19! maybe i am wrong.
Bioniche is expected to achieve a series of milestones this year culminating in the release of Phase III results for its bladder cancer drug and Econiche approval in 4Q10. Bioniche presents great value and home run potential with its products under development."
A $125 million market cap is ridiculous.Blockbuster Urocidin (Bladder Cancer) results coming any day now .Bioniche could hit $6+ easily with Urocidin results .Urocidin has high chance of success ,its a small study .
Strong Buy on Barchart
http://www.barchart.com/quotes//BNC.TO
3x BUY (current month)
http://in.reuters.com/finance/stocks/analyst?symbol=BNC.TO
Best-Rated Canadian Stocks (Oct 17, 2010)
Below are the best-rated Canadian stocks based on average Wall Street analyst ratings. Each analyst rating is assigned a number ranging from 1 to 5, with 1 being the highest rating (STRONG BUY) and 5 being the lowest rating (STRONG SELL). Then the average is calculated to represent the overall rating of a stock.
Ranking | Company (Ticker) | Average Rating Value | Average Rating
1 AlarmForce Industries (TSE:AF) 1.00 Strong Buy
2 Altius Minerals Corporation (TSE:ALS) 1.00 Strong Buy
3 Amorfix Life Sciences Ltd. (TSE:AMF) 1.00 Strong Buy
4 Aquila Resources Inc. (TSE:AQA) 1.00 Strong Buy
5 Aeroquest International Limited (TSE:AQL) 1.00 Strong Buy
6 Bioniche Life Sciences (TSE:BNC) 1.00 Strong Buy
I think the major Bladder Cancer final results will be out within 2-3 Weeks .Market Cap of 130 Mil$ is wayyy Undervalued for a 2 Billion$ Blockbuster Drug .Anything below 2 Dollar is a big gift .Patience will payoff big time . ALL THE BEST
AusBiotech2010
19 to 22 October 2010
http://ausbiotech2010.com.au/uploads/Program/Graeme%20McRae.pdf
November 9, 2010
Annual & Special Meeting of Shareholders
* 4:00 p.m. Eastern
* Fairfield Inn & Suites
* 407 North Front Street
* Belleville, Ontario
November 10, 2010
Fiscal 2011
* Q1 Financials
* News Release
UPCOMING MILESTONES 2010 :
UROCIDIN PHASE 3 RESULTS
ECONICHE USDA APPROVAL
BIG MILESTONE PAYMENT FROM ENDO
re pullback is a opportunity to load up the truck
Bladder cancer phase 3 coming within 2 Weeks .market cap of 135 million dollars is ridiculous for a 2 billion dollar drug .
BELLEVILLE, Ontario and CHADDS FORD, Pa.-- Bioniche Life Sciences Inc. (TSX: BNC OTC:BNHLF) and Endo Pharmaceuticals (Nasdaq: ENDP) jointly announced today that Endo has licensed from Bioniche the exclusive rights to develop and market Urocidin(TM) in the U.S. with an option for global rights. Urocidin is a patented formulation of Mycobacterial Cell Wall-DNA Complex (MCC) developed by Bioniche for the treatment of non-muscle-invasive bladder cancer that is currently undergoing Phase III clinical testing.
Under the agreement signed by both companies, Endo will pay Bioniche an up-front cash payment of $20M USD and the potential for up to $110M USD in additional payments linked to the achievement of future clinical, regulatory, and commercial milestones. In addition, Bioniche will manufacture the product and receive a transfer price for supply.
"We are excited about the opportunity to expand our portfolio in bladder cancer treatment and enhance our late stage development pipeline," said David Holveck, president and chief executive officer of Endo Pharmaceuticals. "In August Endo plans to launch Valstar(TM), for the treatment of bladder cancer. If successful in clinical development, Urocidin has the potential to extend and enhance our recent therapeutic expansion and strengthen the Valstar franchise."
Graeme McRae, Chairman, President & CEO of Bioniche, added, "Endo Pharmaceuticals represents the optimal development and commercialization partner for Bioniche, given its understanding of the bladder cancer market and breadth of pharmaceutical industry experience. We look forward to advancing the Urocidin development and commercialization program in collaboration with the Endo team. Equally, we are very excited about the potential returns to Bioniche and its shareholders following commercialization of Urocidin."
Bladder Cancer and the Ongoing Phase III Clinical Program for Urocidin(TM)
In North America, bladder cancer is the fourth most common cancer in men and in the top ten for women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year. In addition, the cancers of many previously-diagnosed patients remain unresolved, sometimes leading to cystectomy (bladder removal) or death. Approximately 70 percent of bladder cancer patients have the non-muscle-invasive form of bladder cancer at diagnosis and, on appropriate regulatory approvals, might be eligible for multiple treatments with Urocidin.
Non-muscle-invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.
The first of two Phase III U.S. Food and Drug Administration (FDA)-approved and Fast Track designated registration trials with Urocidin is nearing complete enrolment. In this trial, patients with non-muscle-invasive bladder cancer whose cancer is specifically refractory (unresponsive) to current therapy are receiving Urocidin in an open label trial. Thirty-one urology centres in North America are participating in this trial and recruitment of 105 evaluable patients was completed in March, 2009.
Data from the full cohort of evaluable patients from this trial, coupled with additional safety information to be collected from a second registration trial, will be used to support regulatory submissions under the FDA's Accelerated Approval program.
Bioniche plans to conduct a second registration trial that will directly compare the efficacy and safety of Urocidin with current therapy in the first-line treatment of non-muscle-invasive bladder cancer. In September, 2007, Bioniche announced that an agreement had been reached with the FDA under the Special Protocol Assessment (SPA) procedure on the design of the trial, including its endpoints, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologics Licensing Application (BLA). An SPA gives a clear pathway to registration of MCC when the trial endpoints are achieved. This trial received Fast Track designation by the FDA last year. With Endo's support, Bioniche will commence this multi-centre trial, setting up clinical trial centres immediately.
About Urocidin(TM)
Urocidin is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin is formulated for the treatment of bladder cancer, where it is administered by trans-urethral catheter directly into the bladder, coming into contact with immune system cells and bladder cancer cells. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan that is recoupable from sales.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs approximately 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. Bioniche has been named one of the Top 50 Best Small and Medium-Sized Employers in Canada for 2009. For more information, please visit www.Bioniche.com.
About Endo Pharmaceuticals Inc.
Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used to treat and manage pain, overactive bladder, prostate cancer and the early onset of puberty in children, or central precocious puberty (CPP). Its products include LIDODERM(R), a topical patch to relieve the pain of postherpetic neuralgia; PERCOCET(R) and PERCODAN(R) tablets for the relief of moderate-to-moderately severe pain; FROVA(R) tablets for the acute treatment of migraine attacks with or without aura in adults; OPANA(R) tablets for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate; OPANA(R) ER tablets for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time; and VOLTAREN(R) Gel, a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment such as those of the hands and the knees. Voltaren(R) Gel is owned and licensed by Novartis AG; SANCTURA(R) and its XR version for treatment of overactive bladder, VANTAS(R) for the palliative treatment of advanced prostate cancer, and SUPPRELIN(R) LA for the treatment of early onset puberty in children. The company markets its branded pharmaceutical products to physicians in pain management, neurology, surgery, oncology, endocrinology and primary care. More information, including this and past press releases of Endo Pharmaceuticals, is available at www.endo.com.
Read the full report: http://biomedreports.com/200907102044/bioniche-life-sciences-inc-and-endo-pharmaceuticals-sign-licensing-agreement-for-urocidintm.html#ixzz12kHZ4UG8
BNC.TO is very strong again ..2 dollar + coming
http://ih.advfn.com/p.php?pid=webchart&symbol=TSE:BNC&period=0&size=19&volume=1
Positive Phase 3 coming in a few days = next dendreon
Target is 8-10$ by year end ...
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 .
No news items to display
Recent Trades - Last 10 of 22
Time ET Ex Price Change Volume
16:18:21 Q 1.784 0.171 27,400 <<<<<
16:13:42 Q 1.784 0.171 2,400 <<<<<
16:13:03 Q 1.784 0.171 25,000 <<<<<<
15:38:48 Q 1.7122 0.0992 1,900
15:37:37 Q 1.7421 0.1291 1,000
15:37:37 Q 1.7421 0.1291 100
15:37:37 Q 1.7322 0.1192 1,000
15:37:37 Q 1.7322 0.1192 2,500
15:36:15 Q 1.7613 0.1483 1,000
15:35:47 Q 1.7714 0.1584 2,000
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.
THE RUNUP HAS JUST BEGUN ...ENJOY THE RIDE TO $10+ !!
POSITIVE PHASE III RESULTS IS COMING IN A FEW DAYS .DONT MISS THE NEXT HGSI OR DNDN .YOU´LL BE SORRY .
POSITIVE PHASE 3 RESULTS WILL PUSH THIS STOCK TO $5-6 EASILY .PHASE 3 SUCCESS WILL TRIGGER A 60 MIL$+ MILESTONE PAYMENT TO BNC
Bioniche Life Sciences (BNC.TO)
Market Cap: 120 Mil$
Cash: 22 Mil $
Price: 1,60 $
CHECK IT OUT
http://www.rttnews.com/Content/TopStories.aspx?Id=1421944
****** BUY RATING BY DUNDEE SEC ******
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$112.5 million in gross profitfor Bioniche,” Mr. Martin says .
-------------------------------------------------
Chief Medical Officer exercise his option for 130000$ =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 $1.100
Sep 20/10 Sep 16/10 Charette, Francois Guy Direct Ownership Common Shares 51 - Exercise of options 80,000
.90
RALLYYYY WILL CONTINUE TODAY ..PHASE 3 RESULTS COMING IN A FEW DAYS ..DONT MISS IT !!
Two New Presentations within 2 Weeks !!!!
Endo Pharmaceuticals at Jefferies & Co. Global SpecPharma & European Healthcare Conference
Wednesday, October 6, 2010 10:30 a.m. UKT
http://phx.corporate-ir.net/phoenix.zhtml?c=123046&p=irol-EventDetails&EventId=3408691
------
AusBiotech2010
19 to 22 October 2010
http://ausbiotech2010.com.au/uploads/Program/Graeme%20McRae.pdf
-----
STILL VERY VERY VERY CHEAP AT THIS LEVEL .SEE YOU AT 10$+ BY YEAR END !
http://ih.advfn.com/p.php?pid=webchart&symbol=TSE:BNC&period=0&size=19&volume=1
Signs of big Phase3 Success
BIG PAYDAY IS COMING FOR BNC SHAREHOLDERS .I LOVE IT .
MAKRET CAP OF 100 MILLION$ IS WAYYYYY UNDERVALUED .
1) Chief Medical Officer exercise his options for ~ 130.000 C$
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
.900
...........
2) Urocidin (Bladder Cancer) Phase 3 is a small Studie with 105 Patients,only "20% complete response” required for Phase 3 success .
Previous Positive Phase 2 Results Involving 128 Patients :
We have a 70% complete response rate in patients who failed othertherapies, so our Phase II data, which is in the public domain, showsabout 128 patients with an average complete response of about 70%.
..........
3) Complete all DMC ( Data Monitoring Committees) Meetings POSITIV :
Since commencement, nine meetings of the independent DMC have recommended to “continue the trial unmodified”
The DMCis an independent group that acts in an advisory capacity to the Company.Its role is to evaluate the progress of the clinical trial,includingmonitoring the safety and efficacy data generated in thetrial.
..........
4) 21 New Employees since Feb 2010 up from 190 to 211 Personnel :
September 10,
The fully-integrated company employs 211 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety
10/02/10
The fully-integrated company employs approximately 190 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety.
..........
5) Positive Comments by CEO , BladderCancer Forum and Alvaro Morales ( Father of BCG )
CEO Graeme McRae
http://www.quintenews.com/2010/09/banner-year-for-bellevilles-bioniche/
Shareholders will be really happy in two to three years when productionof the bladder cancer drug starts to roll onto the market.
BladderCancer Forum (4 months ago)
http://www.bladdercancersupport.org/index.php?option=com_kunena&Itemid=114&func=view&catid=8&id=31827&limit=6&limitstart=12#31862
I can tell you that the people I know at Bioniche are extremely positive about their product.
Alvaro Morales
http://community.advanceweb.com/blogs/al_1/archive/2009/07/13/an-immunotherapy-success-story-bcg-and-bladder-cancer.aspx
Dr Morales, professor of urology and oncologyat Queen’s University, Kingston, Ont., and principal investigator ofthe trial: “My own experience suggests very stronglythat the safety profile of MCC is much better than BCG and,certainly, MCC iseasier to handle, from the pharmacist’s,nurse’s and physician’s points ofview,due to the risk of acquiring a serious infection fromimproper handling o fBCG,which is a live bacteria,as opposed to MCC thatcontains only bacterial cell wall fragments and DNA.”Dr. Morales is editorof The Chronicle of Urology &Sexual Medicine.
........
6) Early (5 months) Exercise of option to take the World Wide Rights for Urocidin by Endo Pharma !
http://www.biospace.com/news_story.aspx?NewsEntityId=170692
Bioniche Life Sciences Inc. (BNC) Achieves Two Additional Milestones Under Licensing Agreement; Endo Pharmaceuticals (ENDP) Takes up Global Rights; Bioniche to Get $8 Million
2/12/2010
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More Information about Bioniche :
http://www.stockhouse.com/Bullboards/MessageDetail.aspx?s=BNC&t=LIST&m=28632016&l=0&pd=0&r=0
LAST CHANCE TO GET IN CHEAP !
BNC HITS NEW 2 YEAR-HIGH TODAY = MAJOR BREAKOUT COMING
http://www.barchart.com/chart.php?sym=BNC.TO&style=technical&p=DO&d=O&sd=&ed=&size=M&log=0&t=CANDLE&v=1&g=1&evnt=1&late=1&o1=&o2=&o3=&x=28&y=9&sh=100&indicators=SMA%28200%2C16711680%29&chartindicator_2_code=SMA&chartindicator_2_param_0=200&chartindicator_2_param_1=16711680&addindicator=&submitted=1&fpage=&txtDate=#jump
Market cap of 90 M$ is wayyyyyyy undervalued .
Urocidin (Bladder Cancer) Phase 3 results in September (VERY LOW RISK ) . Only 105 Patients in current Phase 3 .Check out the POSITIVE Phase2 results from 2008 involving 128 Patients (see post below) !!!!
TWST: Give us more detail on that pipeline. What is near term and what is a little longer term?
Mr. McRae: The primary technology is called Mycobacterial Cell Wall-DNA Complex, and it sounds like a mouthful but really we found a naturally occurring bacteria where the DNA of the bacteria had a very unusual property ' it can actually kill cancer cells. It kills cancer cells in the face of mutations that would normally stop chemotherapy or radiation therapy from being effective. [B]This DNA is quite unique in that the tumor cells, even when they try to mutate around it, are unable to induce resistance to this compound; and it's extremely safe. We have a 70% complete response rate in patients who failed other therapies, so our Phase II data, which is in the public domain, shows about 128 patients with an average complete response of about 70%. These are patients who at the end of the study were disease-free and had really no side effects worth noting due to the product.[/B] The patients were able to maintain treatment, whereas without the treatments they drop out because of side effects, so that is our primary technology. It has been shown effective in-vitro in the lab against many different types of cancer. In fact, we can't find a cancer cell it doesn't kill. But in our clinical plan, it is bladder cancer first and prostate cancer second. In prostate cancer, we have completed a Phase I study
Why can't I see any of the posts on the boards when I type in the ticker symbol? It says "No Board." What is going on? I had to go to my old posts to post the last two posts here???!!!
O/S dropped by 500,000 shares! From just the other day of 73 million to 72.5 million! Something just may be up indeed!
NEW 52W HIGH woooohooooo.. MAJOR BREAKOUT COMING
http://ih.advfn.com/p.php?pid=webchart&symbol=TSE:BNC&period=0&size=19&volume=1
Septemer 30th, 2010 approval? I bought a few as it was climbing a couple of days ago. This should climb higher towards the end of September if approval in US is by EOMonth 9/30/2010. (Do you have any links showing/proving cattle ecoli vaccine date is in the pipeline?)
POSITIVE RESULTS WILL PUSH THIS STOCK TO$6+ EASILY .GLTA
Bioniche life sciences ( BNC.TO )
Only 105 patients in current PhaseIII !!!!
Positive results from 2008 INVOLVING 130 PATIENTS !!!!
In November 2008,
during a meeting of urologists in Santigo Chile, the biopharmaceutical research company presented positive clinical studies (one and two) involving 130 bladder cancer patients treated with Urocidin. Elderly patients (average 73 years old) during the clinical studies noted excellent safety results
------------------------
Bioniche Phase III Clinical Trial With Urocidin(TM) Given Continued Green Light By DMC
The Data Monitoring Committee (DMC) held its ninth meeting regarding this clinical trial last week. After its meeting, the Committee has recommended that Bioniche "continue the trial unmodified until the next scheduled or triggered meeting."
The DMC is an independent group that acts in an advisory capacity to the Company. Its role is to evaluate the progress of the clinical trial, including monitoring the safety and efficacy data generated in the trial.
THE RUNUP HAS JUST..........Next DENDREON HERE !!!
POSITIVE results coming next Month.Don´t miss the BIG OPPORTUNITY
FDA approval for Econiche (E.coli Vaccine) & Urocidin (Bladder Cancer) Phase III results in 3Q 2010 !!
Bioniche Has The Potential To Become The Next 10-Bagger .GOOD LUCK !!!!!!!
Bioniche Life Sciences (TSX: BNC) !!
Market Cap: 72 Mil $
Cash: 22 Mil $
Price: 0,99 $
Dundee Sec with Buy-Rating (June 2010)....
Bioniche has three businesses with diversified risk/reward profiles:Animal Health, which is expected to generate around $28 million in salesin fiscal 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 a vaccine for reducing E. coli 0157 in cattle feces, and apipeline of other vaccines.
Mr. Martin points out that Urocidin provides the “biggest upsidepotential” for Bioniche investors. His initial diligence suggests thatUrocidin has a “relatively high overall probability of approval,” eventhough the first of two planned Phase 3 trials has a moderate level ofrisk, as the refractory patients enrolled in the trial are a“tougher-to-treat” population than was enrolled in the Phase 2 trial, hesays.
Mitigating the risk somewhat is the 20% “complete response” hurdlerequired for Phase 3. That compares with the company’s Phase 2 results,where patients achieved a 46.4% CR rate at 26 weeks in a population thatwas mainly relapsed but also included a few patients being treated forthe first time.
A second planned Phase 3 trial will test Urocidin head-to-head againstthe current standard of care, baccilus Calmette-Guerin (BCG) infirst-line treatment, “where we expect Urocidin to demonstrate betterefficacy, based on prior data, and superior safety and tolerability,” hepredicts.
In 2009, Bioniche licensed Urocidin’s U.S. commercial rights to EndoPharmaceuticals. Based on incidence of bladder cancer and possiblepricing, he figures the global market opportunity for Urocidin in therefractory population could be $800 million. If the second Phase 3 trialexpands the Urocidin label to first-line treatment, the marketopportunity could grow to an estimated $2 billion.
“Twenty-five percent penetration of this market would represent $500million in annual sales and an estimated $112.5 million in gross profitfor Bioniche,” Mr. Martin says .
fda approval 30-09-2010
hello,when will they get approval fda fase 3
RALLLYYYY HAS JUST BEGUN !!!
Positive results is around the corner..Dont miss the train !!
FDA approval for Econiche (E.coli Vaccine) & Urocidin (Bladder Cancer) Phase III Data in 3Q 2010 !! .Please do your own Homework.
Bioniche Has The Potential To Become The Next 10-Bagger .GLTA !!
Bioniche Life Sciences (TSX:BNC) !!
Market Cap: 74,6 Mil $
Cash: 22 Mil $
Price: 1,03 $
Dundee Sec with Buy-Rating (June 2010)....
Bioniche has three businesses with diversified risk/reward profiles:Animal Health, which is expected to generate around $28 million in salesin fiscal 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 a vaccine for reducing E. coli 0157 in cattle feces, and apipeline of other vaccines.
Mr. Martin points out that Urocidin provides the “biggest upsidepotential” for Bioniche investors. His initial diligence suggests thatUrocidin has a “relatively high overall probability of approval,” eventhough the first of two planned Phase 3 trials has a moderate level ofrisk, as the refractory patients enrolled in the trial are a“tougher-to-treat” population than was enrolled in the Phase 2 trial, hesays.
Mitigating the risk somewhat is the 20% “complete response” hurdlerequired for Phase 3. That compares with the company’s Phase 2 results,where patients achieved a 46.4% CR rate at 26 weeks in a population thatwas mainly relapsed but also included a few patients being treated forthe first time.
A second planned Phase 3 trial will test Urocidin head-to-head againstthe current standard of care, baccilus Calmette-Guerin (BCG) infirst-line treatment, “where we expect Urocidin to demonstrate betterefficacy, based on prior data, and superior safety and tolerability,” hepredicts.
In 2009, Bioniche licensed Urocidin’s U.S. commercial rights to EndoPharmaceuticals. Based on incidence of bladder cancer and possiblepricing, he figures the global market opportunity for Urocidin in therefractory population could be $800 million. If the second Phase 3 trialexpands the Urocidin label to first-line treatment, the marketopportunity could grow to an estimated $2 billion.
“Twenty-five percent penetration of this market would represent $500million in annual sales and an estimated $112.5 million in gross profitfor Bioniche,” Mr. Martin says .
Positive results is coming ....Get ready for blast off !!
http://www.bladdercancersupport.org/index.php?option=com_kunena&Itemid=114&func=view&catid=8&id=31827&limit=6&limitstart=12#31862
Re:Lowered dose BCG - so far so good 3 Months, 1 Week ago
Hi Alan
Bioniche is the sponsor of our Canadian bladder cancer network website.
www.cbcan.org
The trials are continuing in phase 111. Should have some preliminary results late this year.
Results comparing their product directly vs BCG will be a few years away.
Phase 111 trials are BCG refractory patients.
I can tell you that the people I know at Bioniche are extremely positive about their product.
When I hear more information I will post.
Ja
This stock is ready to takeoff ..
Strong buy for Bioniche
http://www.nasd100.com/2010/08/bestrated-canadian-stocks-aug-1-2010.html
Top 100 Strong Buy Canadian stocks for August 1, 2010
Below are the top 100 Strong Buy Canadian stocks based on average Wall Street analyst ratings. Each analyst rating is assigned a number ranging from 1 to 5, with 1 being the highest rating (STRONG BUY) and 5 being the lowest rating (STRONG SELL). The average is calculated to represent the overall rating of a stock.
Ranking | Company | Average Rating Value | Average Rating
1 AlarmForce Industries (TSE:AF) 1.00 Strong Buy
2 Altius Minerals Corporation (TSE:ALS) 1.00 Strong Buy
3 Amorfix Life Sciences Ltd. (TSE:AMF) 1.00 Strong Buy
4 Aquila Resources Inc. (TSE:AQA) 1.00 Strong Buy
5 Aeroquest International Limited (TSE:AQL) 1.00 Strong Buy
6 Bioniche Life Sciences (TSE:BNC) 1.00 Strong Buy <<<<<<<<<<<<<<<<<
FDA Decision + Phase 3 Data in 3Q 2010
FDA approval for Econiche (E.coli Vaccine) & Urocidin (Bladder Cancer) Phase 3 results in 3Q 2010 !! Bioniche has tremendous upside Potential .Please do your own Homework.
Bioniche Has The Potential To Become The Next 10-Bagger .Good Luck to All !!!!!!
Bioniche Life Science (BNC.TO) or (BNHLF.PK) Canadian Stock !!
Market Cap: 74,6 Mio $
Cash: 22 Mio $
Price: 1,03 $
Dundee Sec with Buy-Rating (June 2010)....
Bioniche has three businesses with diversified risk/reward profiles:Animal Health, which is expected to generate around $28 million in salesin fiscal 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 a vaccine for reducing E. coli 0157 in cattle feces, and apipeline of other vaccines.
Mr. Martin points out that Urocidin provides the “biggest upsidepotential” for Bioniche investors. His initial diligence suggests thatUrocidin has a “relatively high overall probability of approval,” eventhough the first of two planned Phase 3 trials has a moderate level ofrisk, as the refractory patients enrolled in the trial are a“tougher-to-treat” population than was enrolled in the Phase 2 trial, hesays.
Mitigating the risk somewhat is the 20% “complete response” hurdlerequired for Phase 3. That compares with the company’s Phase 2 results,where patients achieved a 46.4% CR rate at 26 weeks in a population thatwas mainly relapsed but also included a few patients being treated forthe first time.
A second planned Phase 3 trial will test Urocidin head-to-head againstthe current standard of care, baccilus Calmette-Guerin (BCG) infirst-line treatment, “where we expect Urocidin to demonstrate betterefficacy, based on prior data, and superior safety and tolerability,” hepredicts.
In 2009, Bioniche licensed Urocidin’s U.S. commercial rights to EndoPharmaceuticals. Based on incidence of bladder cancer and possiblepricing, he figures the global market opportunity for Urocidin in therefractory population could be $800 million. If the second Phase 3 trialexpands the Urocidin label to first-line treatment, the marketopportunity could grow to an estimated $2 billion.
“Twenty-five percent penetration of this market would represent $500million in annual sales and an estimated $112.5 million in gross profitfor Bioniche,” Mr. Martin says .
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Bioniche to Get up to $130M in Urology Deal with Endo
http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=51437
Crystal Research 18.02.2010
http://www.crystalra.com/pdf/BNC_2QFY10_Update_02-18-10.pdf
Urocidin Potential New Treatment for Bladder Cancer
http://www.associatedcontent.com/article/1939454/urocidin_potential_new_treatment_for_pg3.html?cat=70
Some Positive Signs ..
UPDATE 1-Bioniche gets $6 mln milestone payment from Endo Pharma
http://www.reuters.com/article/idUSBNG43432420091106
---
Bioniche obtains two additional milestones under licensing agreement with Endo
http://www.tradingmarkets.com/news/stock-alert/bnhlf_endp_bioniche-obtains-two-additional-milestones-under-licensing-agreement-with-endo-777521.html
--
All DMC (Data Monitoring Committee) are Positive !!!!
Bioniche Phase III Clinical Trial With Urocidin(TM) Given Continued Green Light By DMC
http://www.medicalnewstoday.com/articles/161677.php
Only 105 patients in current PIII !!!!
In November 2008,
during a meeting of urologists in Santigo Chile, the biopharmaceutical research company presented positive clinical studies (one and two) involving 130 bladder cancer patients treated with Urocidin. Elderly patients (average 73 years old) during the clinical studies noted excellent safety results .
Upcoming Milestones 2010
2009/2010 Conditional license for E. coli cattle vaccine in the U.S.
2009/2010 Achievement of pre-commercialization milestone payments for
UrocidinTM
2010 First U.S. sales of E. coli cattle vaccine
2010 Results of refractory Phase III bladder cancer trial
2011 Belleville, ON vaccine manufacturing centre operational
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