Bladder Cancer PIII Data in 2Q 2010--Mcap 53 M$

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Permalink Reply by Carl Pechstein on February 12, 2010 at 11:21am

Fantastic News out ...

Bioniche is the next Dendreon !!!!!!!!!


http://finance.yahoo.com/news/Bioniche-Achieves-Two-cnw-1101331284....

Bioniche Achieves Two Additional Milestones Under Licensing Agreement; Endo Takes up Global Rights

Press Release Source: Bioniche Life Sciences Inc. On Friday February 12, 2010, 10:00 am EST

- Payment to Bioniche of US$8M by Endo Pharmaceuticals -

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Permalink Reply by Carl Pechstein on February 16, 2010 at 12:24pm

Last chance to buy under 1$ ........

Urocidin (Bladder cancer) PIII results in 2Q 2010

Positive Results will push this stock to 5$ ++ ....Please do your own DD !!

Bioniche Life Science (BNC.TO)

Market Cap: 81 Mio C$
Cash: 30 Mio C$
Price: 0,94 C$


Bioniche shares jump 34% on Endo taking up global rights
February 12, 2010 by biotuesday
http://biotuesday.ca/2010/02/12/bioniche-shares-jump-34-on-endo-tak...


Upcoming Milestones

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 NMI bladder cancer trial

2011 Belleville, ON vaccine manufacturing centre operational


Insider activity
http://canadianinsider.com/coReport/allTransactions.php?ticker=bnc


Urocidin (Bladder Cancer) PII Results
http://www.medicalnewstoday.com/articles/139517.php


1,50 $ TGT by Haywood
http://www.haywood.com/pdffiles/BNCJul142009.pdf


SECTOR OUTPERFORM; Target: $1.50 Risk: SPECULATIVE

Partnership Agreement Puts BNC Back on Track

ALPHA: We see significant upside to investors. BNC's share price

reflects a value for the Animal Health division only - that is at 5x

2009 EBITDA or
.50/shr. We note the US$20M upfront from the Endo

agreement is worth ~
.25/shr alone. We disagree with the market that

the Human Health division with Urocidin is currently worth zero to BNC and investors.

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Permalink Reply by Carl Pechstein on February 19, 2010 at 11:45am

Great Research by Crystal
http://www.crystalra.com/pdf/BNC_2QFY10_Update_02-18-10.pdf

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Permalink Reply by Carl Pechstein on February 26, 2010 at 1:38pm

A Major Breakout in the making
http://de.advfn.com/p.php?pid=staticchart&s=TSE%3ABNC&p=0&a...

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Permalink Reply by Carl Pechstein on March 5, 2010 at 1:34pm

UP UP AND AWAY ....

We could see 4-5$ within 2 months .Phase III Results in April 2010 !!!

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Permalink Reply by Carl Pechstein on March 8, 2010 at 11:54am

UP UP AND AWAY ...

http://de.advfn.com/p.php?pid=staticchart&s=TSE%3ABNC&p=0&a...

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Permalink Reply by Carl Pechstein on March 16, 2010 at 1:12pm

Update ..

Bioniche could be the next (DNDN) Dendreon..

Urocidin (Bladder cancer) PIII results in April 2010 .Urocidin has BLOCKBUSTER POTENTIAL !!!!


Bioniche Life Science (BNC.TO)

Market Cap: 105 Mio C$
Cash: 30 Mio C$
Price: 1,21 C$


Upcoming Milestones

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



Insider activity
http://canadianinsider.com/coReport/allTransactions.php?ticker=bnc




Strong Bullish Chart
http://www.barchart.com/opinions/BNC.TO



Urocidin Potential New Treatment for Bladder Cancer
http://www.associatedcontent.com/article/1939454/urocidin_potential...


Urocidin (Bladder Cancer) PII Results
http://www.medicalnewstoday.com/articles/139517.php



Discussion board of people dealing with bladder cancer and discussing BCG treatment and MCC
http://www.inspire.com/groups/bladder-cancer-advocacy-network/discu...





Crystal Research 18.02.2010
http://www.crystalra.com/pdf/BNC_2QFY10_Update_02-18-10.pdf

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Permalink Reply by Carl Pechstein on April 5, 2010 at 10:45am

Urocidin (Bladder cancer) PIII results in April 2010 .Urocidin has BLOCKBUSTER POTENTIAL (1-1,5 Billion Dollar Market Potential )

PIII RESULTS WILL BE POSITIVE ..MARK THIS POST !!! >>>> TIME TO BUY br />

Bioniche Life Science (BNC.TO) or (BNHLF.PK)

Market Cap: 86 Mio $
Cash: 30 Mio $
Price: 0,96 $


Belleville, Ontario, Canada – August 24, 2009 - Bioniche Life Sciences Inc. (“Bioniche”; TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today provided an update on its Phase III clinical program evaluating UrocidinTM in the treatment of bladder cancer. Recruitment has been completed in its Phase III registration trial evaluating Urocidin in the treatment of non-muscle-invasive bladder cancer that is refractory (unresponsive) to the current standard immunotherapy – Bacillus Calmette-Guérin (BCG).

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 next scheduled meeting of the Committee is scheduled to occur in October.




Upcoming Milestones

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 NMI bladder cancer trial

2011 Belleville, ON vaccine manufacturing centre operational

• ▶ Reply

Permalink Reply by Carl Pechstein on April 6, 2010 at 1:09pm

Still very very cheap ..dont miss the train !!

Realtime Chart
http://ih.advfn.com/p.php?pid=staticchart&s=T%5EBNC&p=0&...

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Permalink Reply by Carl Pechstein on April 26, 2010 at 4:13am

PIII Results within 4 Weeks ..

Strong buy on Barchart & NASD100
http://www.barchart.com/quotes/BNC.TO


Best-Rated Canadian Stocks Updated Apr 25, 2010

5 Bioniche Life Sciences (TSE:BNC) 1.00 Strong Buy

http://www.nasd100.com/2010/04/bestrated-canadian-stocks-updated-ap...

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Permalink Reply by Carl Pechstein on May 27, 2010 at 11:41am

PIII Results any day now ...

Buy-Rating (Dundee)

26 May 2010
BIONICHE – BLADDER CANCER UPSIDE, BASE BUSINESSPROTECTS DOWNSIDE

Bioniche has 3 businesses with diversified risk/rewardprofiles: 1) Animal Health, which is expected to generate $27-$28 million insales in fiscal 2010; 2) Human Health, with lead product, Urocidin, in Phase 3testing for bladder cancer (results expected mid-2010); 3) Food Safety, with anapproved (in Canada) vaccine for reducing E. coli 0157 in cattle feces (U.S.conditional license pending) and a pipeline of other vaccines. The commonelement linking most of the company’s products and development programs isimmune stimulation.

Animal Health

We view Animal Health as a stable business and a value backstop for the higher risk/rewardopportunities. Our estimated F2010 sales of $27-$28 million would be lower Y/Yvs F2009 (sales $33 million) due mainly to foreign exchange impact and softnessin some end markets due to the economic turndown. However, 2011 could be abetter year with the economy recovering and potential for geographic expansionof Folltropin.

Urocidin

Urocidin (Mycobacterial Cell Wall-DNA Complex, or MCC)provides the biggest upside potential forBNC investors, with Phase 3 results expected mid-2010. MCC is a DNA/proteinisolate from non-pathogenic mycobacterium, phlei. Its main action is tostimulate direct pro-apoptotic and indirect immune-mediated killing of cancercells in patients with non-invasive bladder cancer.

Our initial diligence suggests that Urocidin has arelatively high overall probability of approval, although the first of twoplanned Phase 3 trials has a moderate level of risk – the refractory patientsenrolled in the first Phase 3 are a “tougher-to-treat” population than wasenrolled in Phase 2. Mitigating the risk to a degree, is the 20% completeresponse (CR) hurdle for Phase 3 – in Phase 2, patients achieved a 46.4% CRrate at 26 weeks in a population that was mainly relapsed, but also included afew 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 against the current standard of care, baccilusCalmette-Guerin (BCG) in first-line treatment, where we expect Urocidin todemonstrate better efficacy based on prior data, and superior safety and tolerability– BCG is a live pathogen, carrying with it risk of contamination, fatalinfection and frequent painful bladder inflammation.

In July 2009, Bioniche licensed U.S. Urocidincommercial rights to Endo Pharmaceuticals (ENDP-Q; unrated). Bioniche receivedan up-front cash payment of $20 million with the potential for as much as $110million in additional payments based on future clinical, regulatory, andcommercial milestones. Subsequently, in February 2010, Endo exercised an optionto license the remaining global commercial rights for Urocidin, paying Bionichea further $8 million, and taking on the remaining Phase 3 development costs.Bioniche will manufacture the product and receive a transfer price for supply.After COGS, we estimate the net to Bioniche will be approximately 20%-25% ofsales. Bioniche currently operates a cGMP facility capable of manufacturing~35,000 Urocidin doses annually, with plans to build a million dose facility ata cost of approximately $30 million (planned funding to be provided bygovernment loans and grants) contingent on success of the upcoming Phase 3trial.

Bladder cancer is the fourth most common cancer in men,and the ninth most common in women. About 500,000 people in the U.S. currentlyhave bladder cancer, and the number of new cases each year is about 70,000 (ofwhich 50,000 have the non-muscle invasive form of the cancer that is eligiblefor Urocidin treatment). Two thirds of patients (33,330) typical do not respondto BCG or relapse within a year. Globally, it is estimated that 80,000 bladdercancer patients become refractory each year.

Based on these estimates, the global market opportunityfor Urocidin in the refractory population would be $800 million – this assumesa per dose cost of $1,000 ($21,000 for a full course of 21 doses, supported bythe $22,000 cost for a full course of Valstar), and assumes that eachrefractory patient receives an average of 10 doses (based on 25% receiving afull course and 75% receiving only the first 6 induction doses). If the secondPhase 3 trial expands the Urocidin label to first line treatment, the marketopportunity would grow to the estimated 2 million doses of BCG sold globallyeach year, or $2 billion. 25% penetration of this market would represent $500million in annual sales, and an estimated $112.5 million in gross profit forBioniche.

Food Safety

Food Safety, the third Bioniche business, is primarilyfocused on development and commercialization of a vaccine for cattle whichlowers the fecal load of pathogenic 0157 E. coli bacteria. The product islicensed in Canada,where the primary market, upscale cattle farms, is very small. The company ishopeful it will receive conditional approval to sell the vaccine in the U.S. this year,where there are many more cattle farms, and a higher percentage (20% vs. 2% bymanagement’s estimate) produce upscale, branded beef.

Near-term Hurdle for Value Inflection

The key hurdle for BNC value inflection will be Phase 3Urocidin results expected mid-2010. We believe there is a moderate-to-goodchance of success for this trial, and we believe with the base Animal Healthbusiness, that downside risk is limited.

Key risks:

Clinical risk –While we believe Urocidin has demonstrated strong indications of superiority(safety and efficacy) vs BCG in prior clinical testing, the hurdle is high forthe upcoming results for the first Phase 3 trial for the bladder cancer drug.Mitigating this risk is the base business of Bioniche, the deep-pocketedpartner for Urocidin, and our view that the long term probability of approvalof the drug is high.

Urocidin pricing - The expected pricing for Urocidin (~$1,000 per dose) is substantiallyhigher than for BCG (~$50 per dose). We believe higher pricing can bejustified, but it will be necessary to continue to demonstrate substantialefficacy and safety benefits in Phase 3.
Base business risk - The base businessis on track for lower sales in F2010 vs F2009. F2011 may see an uptick on theback of better economic growth and specific Animal Health product initiatives,and we believe Urocidin will be the bigger driver of BNC stock in the nearterm.

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Permalink Reply by Carl Pechstein on September 7, 2010 at 11:28am

NEW 52W HIGH woooohooooo.. MAJOR BREAKOUT COMING
http://ih.advfn.com/p.php?pid=webchart&symbol=TSE:BNC&perio...

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