http://www.stockhouse.com/news/press-releases/2016/10/13/theralase-demonstrates-significant-increase-in-survival-for-brain-cancer

Here's something that might explain most of it.

http://www.pharmpro.com/news/2016/02/telesta-receives-fda-response-letter?et_cid=5090990&et_rid=276166769&type=cta&et_cid=5090990&et_rid=276166769&linkid=http%3a%2f%2fwww.pharmpro.com%2fnews%2f2016%2f02%2ftelesta-receives-fda-response-letter%3fet_cid%3d5090990%26et_rid%3d%%subscriberid%%%26type%3dcta

Why the sharp drop?

Here are Two Companies with Upcoming Catalysts in Biotech

http://marketexclusive.com/here-are-two-companies-with-upcoming-catalysts-in-biotech/2195/

REALLY then why FDA says that Telesta can file BLA on existing clinical trial data set ???????



MCNA U.S. Regulatory Update

Following several months of active dialogue with the U.S. Food and Drug Administration (FDA), concerning the most appropriate regulatory pathway for MCNA approval in the United States, Bioniche has received written guidance. This guidance provides
regulatory clarity and permits the submission of an MCNA Biological License Application (BLA) for U.S. marketing approval review based on Bioniche's existing clinical trial data set.

2nd Phase 3 trial possibly needed (from YMB)

The is the likelihood of the FDA recommending the 2nd Phase 3. Most clinical trials require two Phase 3 trials to be run, typically sequentially and sometimes concurrently. Some trials have a single Phase 3 declared at the start as a pivotal Phase 3. In this case the 1st Phase 3 was not initiated as a pivotal trial.
The first Phase 3 enrolled 129 patients and took 4&1/2 years to complete.
There is a reason the stock price is cheap.

Billion Dollar Cancer Drug close to FDA approval if approved then this Stock could be a 10 Bagger .GL


ADCOM on November 18

FDA Decision in 1Q 2016


Telesta Therapeutics (BNHLF) (TST.TO)

Marketcap$115 Million
Cash $45 Million

Price: 0.40



Telesta Therapeutics: Near-Term Catalyst Could Provide Multi-Bagger Returns
http://seekingalpha.com/instablog/592211-john-h-ford/4491146-telesta-therapeutics-near-term-catalyst-could-provide-multi-bagger-returns


Valuation summary (all share prices in US dollars)

· Fair valuation today: $300 million. Shareprice: $1.04.

· Fair valuation following positive advisory committee recommendation: $600 million. Shareprice: $2.08.

· Fair valuation following 2nd Phase 3 trial recommendation: $150 million. Shareprice: $.52.

· For valuation following 2nd phase 3 trial recommendation with concurrent FDA approved drug sales: valuation $400 million. Shareprice: $1.38.

· Fair valuation following FDA approval: $1 billion. Shareprice: $3.47.

· Fair valuation long-term following FDA approval: $3 billion to $4.5 billion. Shareprice: $10.41 to $15.62.

Telesta is currently trading in the $.30 range in the US, so any of the above scenarios would provide significant returns. The only caveat, is that if a 2nd phase 3 trial is recommended, the company could trade well under fair valuation for a period of time.



Telesta provides 3 opportunities that could generate short-term multi-bagger returns:

· Telesta is so undervalued that with any level of Wall Street awareness, the share price could be driven higher. As we get closer to November 18, the shareprice could rise in anticipation of a positive recommendation.

· When the company reports the results of the FDA's advisory committee, if the results are positive, the share price should rise again.

· In February we will learn whether or not the FDA has approved Telesta's lead drug. With FDA approval, Telesta should be worth at least $1 billion and I would expect buyout offers in that range.

FDA precedent has already been established with Valstar's approval, and I believe MCNA with its superior clinical results will be approved in February. In effect, this is an opportunity to buy a soon to be $1 billion company, for $90 million, a true Buffett trade.

This looks exciting. Wonder where all the people are? Under the radar looks like. Once things get approved we fly?

If they get FDA approval wonder how high this can go? Wanted to invest in TSX but live in US so bought the US version. BNHLF.

Yeah I'm in BNHLF too. The US version of TSX Canada. Seems pretty close in share price and their press release show TSX and BNHLF. Very intriguing company.

Bio, you seem to be long. Whats your price target? You have been in this stock, since it has hitten the 2 dollars?

thx

Telesta Therapeutics Inc. (BNHLF)

0.28 Up 0.03(12.19%) 3:58PM EDT 6/30/2015

Prev Close: 0.25
Open: 0.28

Day's Range: 0.27 - 0.30
52wk Range: 0.13 - 0.39
Volume: 550,685
Avg Vol (3m): 92,266

P/E (ttm): 1.56
EPS (ttm): 0.18




FOR IMMEDIATE RELEASE:
Telesta Therapeutics Submits Biologics Licen
se Application (BLA) to the U.S. FDA
?
BLA for MCNA submitted electronically to the US FDA on June 29
th
, 2015
?
Manufacturing facility upgrades completed
and pre-launch production planning initiated
?
FDA waives US$2.3 million application fee for Telesta
Montreal, Quebec, June 30, 2015.
Telesta Therapeutics Inc.
(TSX:TST; PNK:BNHLF)
announced today
that it has submitted electronically, through its U.S. ag
ent, a Biologics License Application (BLA) to the
United States Food and Drug Administration (FDA) for MCNA
1
. MCNA is Telesta’s novel biologic
immunotherapeutic for the treatment of high-risk non
-muscle invasive bladder cancer patients who have
failed first-line BCG therapy.
Telesta also announced today that they have recei
ved from the FDA a waiver exempting Telesta from the
payment of the $US2.3 million BLA application fee.
The FDA has a 60-day filing review period to determ
ine whether Telesta’s BLA submission for MCNA is
complete and acceptable for filing, whether MCNA will
be designated for priority review or standard
review and whether an advisory committee meeting w
ill be scheduled. Their decisions on these items will
be communicated to Telesta in the FDA’s official
filing communication known as the “Day-74 letter”.
Telesta will communicate the FDA’s filing decisions upon receipt.
Telesta’s BLA submission has been made following
extensive and ongoing dialogue with the US FDA,
including a formal pre-BLA meeting in November, 2014
and a Type C facility meeting in February, 2015.
As part of this process, Telesta has incorporated
the FDA’s recommendations into the current submission
and the Company has also been work
ing with top tier regulatory consultants to ensure that their BLA
submission meets all current regulatory requirements.
Concurrently with this BLA submission, Telesta c
onfirmed the completion of a number of upgrades and
improvements to Telesta’s manufacturing facilit
y and operating procedures, undertaken following
recommendations received from the FDA at the Type C fa
cility meeting held in February. As previously
announced, these improvements were implemented by Telest
a to ensure that their manufacturing facility is
well positioned for the FDA pre-approval inspection that
will take place as part of the FDA’s formal review
process.
“The BLA submission for MCNA marks a major step to
wards our ultimate goal of providing bladder cancer
patients and the medical professionals in the urology co
mmunity, with a therapeutic alternative to radical
cystectomy,” said Dr. Michael Berendt, CEO & Chief Scien
tist of Telesta Therapeutics. “There is an urgent
and unmet medical need to develop new therapies
for bladder cancer patients who have not seen new
therapies approved for almost 20 years. I am incr
edibly proud of Telesta’s dedicated and talented
employees, many of whom have been working for more
than a decade to advance th
is important therapeutic
agent, for their hard wo
rk and professionalism that has permitted
us to achieve this key corporate
milestone.”
Current practice guidelines for the treatment of high
-risk non-muscle invasive bladder cancer patients who
are refractory to or have relapsed from first line BCG
therapy call for radical cystectomy (surgical removal
1
Mycobacterium phlei cell wall-nucleic acid complex
- -
2
of the bladder and adjacent organs). MCNA was de
veloped to provide a much-needed therapeutic
option for these patients. This BLA submission is the
first step towards the potential regulatory approval
and commercialization of MCNA, which could become
the first approved therapeutic alternative for these
high-risk bladder cancer patients since 1998. The appr
oval of MCNA in the U.S. could occur as early as
Q1/2016 should the FDA designate the MC
NA BLA submission for priority review.
About MCNA
Telesta’s MCNA is a biologic therapy derived from the
cell wall fractionation of a non-pathogenic bacteria.
Its activity is believed to be through a dual mechanism
of immune stimula
tion and direct anti-cancer effects.
MCNA was developed to be delivered as a sterile susp
ension for intravesical administration by urologists
and urology nurses, following the same dosing paradigm
as first-line BCG therapy, with the advantage that
it can be prepared, handled and disposed of easily and safely. The efficacy, duration of responses and safety
data from MCNA’s pivotal Phase 3 trial were re
cently published in the Journal of Urology
2
. Telesta
continues to prosecute novel composition of matter,
methods of use and manufacturing patents in most
regions of the world and recently announced the granti
ng of the key composition of matter patent in the
United States providing intellectual prope
rty coverage of MCNA to 2031.
A recent commercial assessment, conducted
by Medical Marketing Economics (“MME”),
a global leader
in the development of value-based strategies and market research, employed rigorous
qualitative and
quantitative primary market research with payers
(managed care organizations/decision makers both from
the private and public sector) and over 100 urologists (c
ommunity urologists and key opinion leaders), to
define market size, pricing strategy and market
access context as well as reimbursement potential for
MCNA. This study confirmed a commercial U.S. market
opportunity of more than $400 million and clearly
established that the target product profile of MCNA re
presents an extremely interesting therapeutic option
for practicing urologists.
About Telesta Therapeutics Inc.
Telesta Therapeutics Inc. is a late
stage therapeutics company with n
ear term commercial potential focused
on the manufacturing, marketing and licensing/acquisiti
on of proprietary and innovative therapies for the
global health market. The Company’s primary goal is
to develop and commerciali
ze products that advance
human health and increase shareholder value. For more information, please visit
www.telestatherapeutics.com
Except for historical information, this
news release may contain “for
ward-looking statements” and
“forward-looking information”
within the meaning of applicable
securities laws that
reflect the Company’s cu
rrent expectation regarding future events. Forwar
d-
looking statements and information are necessarily based upon
a number of estimates and assump
tions that, while, considered
reasonable by management, are inherently
subject to significant bus
iness, economic and competitive uncertainties and
contingencies. Readers are
cautioned that any such forward-
looking statements and informa
tion are not guarantees and there can
be no assurance that such statements and information will prove
to be accurate, and actual results and future events could diff
er
materially from those anticipated in such statements and inform
ation. These forward-looking stat
ements and information involve
risk and uncertainties, which may cause, but are not limited
to, changing market conditions, the successful and timely completi
on
of clinical studies, the establishment of corporate alliances
, the impact of competitive pr
oducts and pricing, new product
development, uncertainties related to the re
gulatory approval process, and
other risks detailed from time to time in the Compan
y's
ongoing quarterly and annual reporting. The Company
expressly disclaims any intention or
obligation to update or revise any
forward-looking statements and information whether as a result
of new information, future events or otherwise. All written and
oral forward-looking statements and information attributable to
us or persons acting on our behalf are expressly qualified in t
heir
entirety by the foregoing cautionary statements.
For further information:
Donald Olds, Chief Operating Officer
Telesta Therapeutics Inc.
Telephone: (514) 394-7921
Donald.Olds@telestatherapeutics.com
2
Morales A, Herr H, Steinberg
G, et al. Efficacy and safety of MCNA in
patients with nonmuscle invasive bladder
cancer at high risk for recurrence and progression after fail
ed treatment with bacillus Calmette-Guérin. J Urol. 2015;
193: 1135-1143

What is the difference between BNHLF & BNC? They are both Telesta Therapeutics, yes? Why is their no board for BNHLF on Ihub? This is the Pink Sheets Ticker (BNHLF) that the company lists on their website for the U.S. Market? And is supposedly doing very big things over the next 12 months. However, I'd hate to think after FDA Approval in 2016 that I'm invested in the wrong company..lol.

Telesta Charts

New Presentation

http://telestatherapeutics.com/cms/phpjDm0WL.pdf

Investment Opportunity

•New management team has led transformative change
•Focused on unencumbered, late stage, near-commercial asset for bladder cancer

•BLA filing targeted in Q2/2015 with potential US approval in Q1/2016

•Significant dialogue with US FDA to minimize regulatory risk

•Independent assessment of U.S. market opportunity, market access and pricing

•MCNA specialty product profile validated by 3rd party expressions of interest

•Multiple opportunities to create shareholder value through the achievement of significant regulatory milestones, potential partnering or company sale before or after the US FDA’s BLA decision

Took a starter position here today, GLTA

Share Structure looks really good!
http://ycharts.com/companies/BNHLF/shares_outstanding

BNHLF (MC $33 M) BLA Filing for BIG Bladder Cancer vaccine in this Quarter .

Runup to FDA decision and Approval could drive this Stock close or over $2 per Share ! GL

Market Cap: $33 Million
Cash: $10 Million
Price: $0.19

Presention fron last month
http://www.bioniche.com/pdf/2014/CEO%20Presentation%202014%20Annual%20General%20Meeting.pdf

Bioniche will file BLA with the US FDA, seeking approval for the commercialization of MCNA based on existing clinical data; Target filing date: Q1/2015 . Near term revenue opportunity in the U.S
Potential for marketing approval as early as end of 2015/early 2016 .Exploring potential for US listing .
Pivotal phase 3 study (completed) shows it can delay (or prevent) need for cystectomy (bladder removal) in 25% of patients with high-risk non-muscle invasive bladder cancer (NMIBC) who failed first line BCG treatment

Supported by strong intellectual property coverage
•Patent term expiration: 2031
•Automatic 12 year market exclusivity for novel biologic in US

Of all cancers, bladder cancer has the greatest lifetime treatment cost per patient diagnosed (US, 2010) $230,000 . 80,000 new cases/year in North America .Potential for peak U.S. sales of $200M plus .

Comparable or greater market opportunity ex-US

•NMIBC BCG-failure population only
•50% market penetration
•$3,000 per dose

Bioniche Life Science Inc. changed to Telesta Therapeutics Inc.:

http://otce.finra.org/DailyList

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

Thanks for posting. It's so hard to find info on this stock in the US

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

The offering ($1,50 per Share) creates a great buying Opportunity .Now we know that Urocidin definitely works in Bladder Cancer means this is the next Blockbuster . Market-cap of 125 million$ is wayyy undervalued .Offering will be complete in mid December and the Rally will continue .This Stock is still under Radar .

This is a once in a Lifetime Opportunity .

Upcoming Milestones:

Start of the Global Phase 3 Study in 2010 << trigger a Milestone payment from Endo

Econiche approval in early 2011 (jan or feb) << Major share price driver



INVESTMENT HIGHLIGHTS

• With the recent positive results from Urocidin™’s bladder cancer Phase III
trial, Bioniche’s co-developer, Endo, has committed to invest considerable
financial and other corporate resources to an expanded bladder
cancer programme.

• Endo will commence a large, multi-country, multi-centre additional
clinical trial in refractory patients to gain registration of Urocidin™ in
the USA and Canada.

• Urocidin™ is expected to address a material unmet need in the treatment
of bladder cancer where the current standard of care, BCG, dates
back over 30 years and, the Company believes, has issues with respect
to its efficacy, safety and tolerability.

• Bioniche has invested more than 10 years and approximately C$130 million
in bringing the Urocidin™ technology to its current stage.

• The Animal Health division provides the Company with ongoing cash
flow and is a world market leader in a number of its product offerings.

• With full licensing approval in Canada, the Food Safety division has
developed the world’s first fully licensed cattle vaccine designed to
reduce the E. coli O157 infection rates in humans resulting from consumption
of contaminated beef products, as well as infections related
to exposure to contaminated water and produce.

• The Company is currently investing in the development of other food
safety vaccines including a vaccine to prevent Salmonella in swine,
cattle and chickens.

PHASE 3 SUCCESS IN BLADDER CANCER YIPPIIIIII

PHASE 3 SUCCESS FOR BIONICHE (BNC.TO) .LOAD UP THE TRUCK WE HAVE A HUGE WINNER HERE .MARKET CAP OF 120 MIL$ IS RIDICULOUS .

BNC.TO WILL BE THE NEXT BIG CASH COW .


http://finance.yahoo.com/news/UrocidinTM-Phase-III-Trial-prnews-3143154188.html?x=0&.v=11

Urocidin(TM) Phase III Trial Results Trigger Milestone Payment to Bioniche from Endo

The current milestone payment was triggered by Urocidin™ attaining a contractual efficacy goal from an ongoing U.S. Food and Drug Administration (FDA) Phase III registration trial. Urocidin™ is a product for non-muscle-invasive bladder cancer that is refractory to current first-line therapy. The clinical trial providing results was initiated in late 2006, prior to the execution of the agreement between the parties.

Great News from Endo on Monday 1 Nov 2010..

[B]The Fantastic News is around the corner .THIS SLEEPING GIANT WILL AWAKE VERY SOON .Remember there is NO Insider selling , NO Dilution even after 400% increase in Share price all this indicates that much much higher Share Price and good news is coming . Patience will pay off here big time![/B]

http://www.morningstar.com/earnings/PrintTranscript.aspx?id=18732547


[B]Asa final note, we plan to begin enrolling patients in the next study of Urocidin in refractory bladder cancer during the fourth quarter. This will serve as a registration trial comparing Urocidin to Mitomycin, the current standard treatment for this condition. Urocidin is a novel treatment for bladder cancer and reflects our commitment to this therapeutic area.

I am pleased with our clinical progress and look forward to resolving our marketing applications that are pending before the FDA.[/B]

Ivan Gergel, M.D. - EVP, Research & Development: Soon AVEED, as you know we met with FDA earlier this year. We are still considering the outcome of that meeting. We are still very muchcommitted to AVEED. We believe it has a significant place to play in theworld of testosterone replacement therapy. [B]The other one, the Urocidin study, the phase III study that was just completed. We are finalizing some of the data review, but we hopefully will be able to release date for that quite shortly – from that study quite shortly.[/B]

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

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 .

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 ...

MARKET CAP OF 130 MILLION $ IS STILL RIDICULOUS FOR THIS BEAUTIFUL COMPANY .

RELAX AND ENJOY THE RIDE TO THE FAIR VALUE LEVEL (7-10$) .STAY LONG AND BE STRONG .

THE NEXT 2-3 WEEKS WILL BE VERY VERY INTERESTING .HAVE A NICE WEEKEND ALL.


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


------------

BIONICHE GETS THE HIGHEST RATING AGAIN = STRONG BUY

http://www.nasd100.com/2010/10/best-rated-canadian-stocks-oct-17-2010.html

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 <<<<<<<<<<<<<<<BIONICHE>>>>>>>>>>>>>>

---------------------------------------

ANOTHER STRONG BUY FOR BNC
http://www.barchart.com/quotes//BNC.TO

-----------------------------------------

3 x HIGHEST RATING ON REUTERS TOO = BUY
http://in.reuters.com/finance/stocks/analyst?symbol=BNC.TO

------------------------------------------

this stock is also listed in OTC

BIONICHE LIFE SCIENC
(Public, PINK:BNHLF)

Clarification of Bioniche Experiences Increased Trading Activity


BELLEVILLE, ON, Sept. 27 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology driven Canadian biopharmaceutical company, has noted substantial share trading volume and share price increase over recent days. Management believes that this market activity is driven by expectation of a disclosure concerning its U.S. Food and Drug Administration (FDA) Phase III Fast Track clinical trial with Urocidin(TM) a product for non-muscle-invasive bladder cancer that is refractory to current first-line therapy. Such disclosure is expected to become available within the next several weeks.

This clinical trial involves the use of an intravesical formulation of a patented mycobacterial cell wall composition: Mycobacterial Cell Wall-DNA Complex (MCC), known as Urocidin(TM) (or "EN3348") for treatment-refractory non-muscle-invasive bladder cancer. The trial completed recruitment of patients in March, 2009, with the last patient reaching his/her one-year assessment this spring. Data compilation has been ongoing since that time, with the Company's development partner, Endo Pharmaceuticals Inc., conducting detailed analyses of the data. Such analyses are still ongoing.

The Company's development partner is the party responsible for oversight of the Urocidin(TM) clinical development program. Status updates on the program and future plans to further develop Urocidin(TM) are being defined and will be disclosed by Endo.

It was announced on August 19, 2010 that the parties are finalizing a protocol for an additional clinical trial - expected to begin enrolling patients in 2010.

About Bladder Cancer

In North America, bladder cancer is the fourth most common cancer in men and is in the top ten for women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year and 500,000 living patients have been affected. The cancers of many of the 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 and, on appropriate regulatory approvals, might be eligible for multiple treatments with Urocidin(TM).

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(TM) is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.

Under the licensing agreement, Bioniche received an up-front payment of US$20 million in July, 2009, and has the potential to receive a total of US$110 million in payments associated with the achievement of certain clinical, regulatory and commercial milestones. Four development milestones have been achieved by the Company since November, 2009, resulting in total payments of US$19 million. Future milestones will be announced as they are achieved and, with its exclusive manufacturing supply contract, Bioniche will also receive a net-sales-based revenue stream upon product approval.

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 to be repaid 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 211 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. For more information, please visit www.Bioniche.com.

Except for historical information, this news release may contain forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.


SOURCE Bioniche Life Sciences Inc.

BNC products and pipelines:

http://www.bioniche.com/products.cfm

Bioniche Life Sciences - Gearing Up For D-Day


http://www.rttnews.com/Content/TopStories.aspx?Id=1421944

BNC.TO HITS ANOTHER HIGH TODAY //// ENJOY THE RIDE TO $10+ .

POSITIVE PHASE 3 RESULTS WILL PUSH THIS STOCK TO $6-8 EASILY .PHASE 3 SUCCESS WILL TRIGGER A 60 MIL$+ MILESTONE PAYMENT TO BNC


POSITIVE PHASE III RESULTS IS COMING IN A FEW DAYS .DONT MISS THE NEXT HGSI OR DNDN .YOU´LL BE SORRY .


Bioniche Life Sciences (BNC.TO)

Market Cap: 130 Mil$
Cash: 22 Mil $
Price: 1,80 $

this has potential like DNDN

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

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


-----------------------------------------------------------------------------------------------------------------------------------------------------------


More Information about Bioniche :

http://www.stockhouse.com/Bullboards/MessageDetail.aspx?s=BNC&t=LIST&m=28632016&l=0&pd=0&r=0

going to 10$

carl.pechstein aka scumface ,He is an excellent contraindicator as I have said all along.


THIS HOMO PECHSTEIN BASHES BSDM AT $1 .One week later the stock explodes to 3,50$
http://messages.finance.yahoo.com/Business_%26_Finance/Investments/Stocks_%28A_to_Z%29/Stocks_B/threadview?bn=79227&tid=16194&mid=16198

look what happen 8 days later ..bawahahaha
http://finance.yahoo.com/q/hp?s=BSDM+Historical+Prices


The same story with IPCI .Bought at 1,60$ and sold at 3,20$ .This loser bashes Ipci stock at 1,40$ with his another alias magic_dog2001 one week before the stock explodes to 5$+ .Bawahahaha what a facking Bastard

look at date 2 March 2010
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_I/threadview?m=tm&bn=100164&tid=402&mid=402&tof=1099&frt=2

look what happen one week later
http://finance.yahoo.com/q/hp?s=IPCI&a=00&b=1&c=2010&d=02&e=19&f=2010&g=d


THIS IS A FANTASTIC SIGN FOR BIONICHE ..


This SICK BASTARD post under many multiple aliases to create the illusion that there are many people who hate a stock and a company.

http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_B/threadview?m=tm&bn=83477&tid=512&mid=512&tof=5&frt=2

Here is the updated aliases list:

bingabro
dovetai1sthomas
carl.pechstein a
profit.zero
magic_dog2001
vasreallysux
thegovernor_elect
equity_addict
notpeterlynch
pumpy_pumpster

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

NEW 52W HIGH woooohooooo.. MAJOR BREAKOUT COMING
http://ih.advfn.com/p.php?pid=webchart&symbol=TSE:BNC&period=0&size=19&volume=1

BUYOUT IS COMING !!!

http://finance.yahoo.com/news/Endo-Pharmaceuticals-Looks-ibd-4281469438.html?x=0&.v=1

Endo Pharmaceuticals Looks For Acquisitions
On Friday August 27, 2010, 4:40 pm EDT

To broaden its product base, Endo has also done some in-licensing. In July, 2009, Endo acquired exclusive rights from Bioniche Life Sciences to develop and market phase-three drug Urocidin for bladder cancer in the U.S. with a global marketing option.

Having bought Penwest, Endo can now make all the decisions about Opana without consultation.[B] It also won't need to pay Penwest the 22% in royalties[/B] that were part of the previous partnership deal.

re THE RUNUP HAS JUST BEGUN !!!!

BREAKOUT COMING

Bioniche & University of Ottawa Sign Exclusive Global License Agreement for Natural Health Technology - Yahoo! Finance
http://finance.yahoo.com/news/Bioniche-University-of-Ottawa-cnw-3715696021.html?x=0

Press Release Source: Bioniche Life Sciences Inc. On Wednesday August 25, 2010, 7:00 am

- potential animal health and human health applications for reduction of anxiety -

THE RUNUP HAS JUST BEGUN !!!! get in now before its too late .this stock is a lifetime opportunity .

Bioniche life science (BNC.TO) . Market cap of 80 mil$ is a big joke ..

Positive Phase 3 results coming next month .Urocidin for bladder cancer is a real Blockbuster (1-2 Billion Dollars Potential) .

Positive results will trigger a big milestone payment for Bioniche .

In 2009, Bioniche licensed Urocidin’s U.S. commercial rights to Endo Pharmaceuticals . Based on incidence of bladder cancer and possible pricing, he figures the global market opportunity for Urocidin in the refractory population could be $800 million. If the second Phase 3 trial expands the Urocidin label to first-line treatment, the market opportunity could grow to an estimated $2 billion.


HUGE BREAKOUT IS COMING ...
http://3.bp.blogspot.com/_4f_p2K3hwOo/THHOw07Y25I/AAAAAAAAKBA/jj2FGUf0ybE/s1600/bnc.png" rel="nofollow" target="_blank" >http://3.bp.blogspot.com/_4f_p2K3hwOo/THHOw07Y25I/AAAAAAAAKBA/jj2FGUf0ybE/s1600/bnc.png

http://www.barchart.com/cheatsheet.php?sym=BNC.TO" rel="nofollow" target="_blank" >http://www.barchart.com/cheatsheet.php?sym=BNC.TO

Positive results is coming ......

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

Phase 3 Data within 2 months


about urocidin ..12 min 30 sec ..listen
http://webcastingplayer.corporate-ir.net/player/playerHOST.aspx?c=123046&EventId=3228838&StreamId=1530678&TIK={e045afef-fae6-4f6c-bb2c-289b145e1274}&RGS=3&IndexId=

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 .

--------------------------------------------------------------------

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

Rally will start very soon

UPDATE

USDA 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. Good Luck to All !!!!!!

Bioniche Life Science (BNC.TO) !!!

Market Cap: 74,6 Mio $
Cash: 22 Mio $
Price: 1,03 $


Buy rating by Dundee Sec (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 .

--------------------------------------------------------------------

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



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-a
dditional-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. <<<<<< HUGE MILESTONE

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 <<<<<<<<<HUGE MILESTONE

2011 Belleville, ON vaccine manufacturing centre operational