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RAAALLLLLLLYYYYYYTIIMMMMEEEEEEE
STILL VERY CHEAP !!!!!!!!!!
Bioniche Phase III Clinical Trial with Urocidin(TM) Given Continued Green Light by DMC
* Press Release
* Source: Bioniche Life Sciences Inc.
* On Monday August 24, 2009, 8:47 am EDT
BELLEVILLE, ON, Aug. 24 /CNW/ - 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 Urocidin(TM) 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.
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. On a regular basis, the DMC reviews study results, evaluates the incidence of adverse events, determines whether the basic trial assumptions remain valid, and evaluates whether the overall integrity, scientific merit and conduct of the study remain acceptable.
Data from the full cohort of 105 high-grade bladder cancer patients from this trial, coupled with additional safety information to be collected from a second clinical trial that is expected to start later this year, will be used to support regulatory submissions under the FDA's Accelerated Approval program.
Second Phase III Registration Trial
Bioniche is working with its new licensing partner, Endo Pharmaceuticals Inc., on setting up clinical trial sites for a second registration trial that will directly compare the efficacy and safety of Urocidin with BCG in the first-line treatment of non-muscle-invasive bladder cancer.
In September, 2007, the Company 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 Urocidin when the trial endpoints are achieved. This indication for MCC received Fast Track designation by the FDA last year.
Bioniche Phase III Clinical Trial with Urocidin(TM) Given Continued Green Light by DMC
* Press Release
* Source: Bioniche Life Sciences Inc.
* On Monday August 24, 2009, 8:47 am EDT
BELLEVILLE, ON, Aug. 24 /CNW/ - 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 Urocidin(TM) 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.
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. On a regular basis, the DMC reviews study results, evaluates the incidence of adverse events, determines whether the basic trial assumptions remain valid, and evaluates whether the overall integrity, scientific merit and conduct of the study remain acceptable.
Data from the full cohort of 105 high-grade bladder cancer patients from this trial, coupled with additional safety information to be collected from a second clinical trial that is expected to start later this year, will be used to support regulatory submissions under the FDA's Accelerated Approval program.
Second Phase III Registration Trial
Bioniche is working with its new licensing partner, Endo Pharmaceuticals Inc., on setting up clinical trial sites for a second registration trial that will directly compare the efficacy and safety of Urocidin with BCG in the first-line treatment of non-muscle-invasive bladder cancer.
In September, 2007, the Company 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 Urocidin when the trial endpoints are achieved. This indication for MCC received Fast Track designation by the FDA last year.
3$ target coming soon
What a great Opportunity !!!
Load up the truck at current levels eom ..
Another good day
RALLLYYYYYYTIMEEEEEEE
Still a great Opportunity ...
Clinical Data licenses cancer drug for $252M
CombinatoRx licenses myeloma drug candidate from Clinical Data for up to $252 million
* On Thursday August 13, 2009, 11:32 am EDT
o
Buzz up! 0
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*
Companies:
o Clinical Data, Inc.
NEW YORK (AP) -- Clinical Data Inc. said Thursday it licensed a potential cancer treatment to CombinatoRx in a deal worth as much as $252 million, plus royalties on sales.
The drug candidate, designated ATL313, is in preclinical testing. It is seen as a possible treatment for multiple myeloma, a cancer of blood plasma cells, and cancers that affect the immune system's B-cells. Clinical Data will get up to $252 million if the drug advances through testing, is approved for sale, and reaches sales targets.
Clinical Data has an option to co-promote the drug, and can exercise that option after mid-stage clinical testing is complete. The Newton, Mass., company said there are about 74,000 new cases of multiple myeloma diagnosed each year, and the disease kills 45,000 people worldwide annually.
Great move ..
Up from 1,80$ to 2,75 $ ..Still a big Opportunity !
re Swine-flu stock flying under Radar !
Warnex and Rosetta Genomics Announce Exclusive Distribution Agreement for Rosetta's microRNA-Based Assays in Canada
Warnex will distribute Rosetta Genomics' three recently launched miRview(TM) tests in Canada
* Press Release
* Source: Warnex Inc.
* On Monday August 10, 2009, 7:30 am EDT
LAVAL, QUEBEC AND REHOVOT, ISRAEL AND PHILADELPHIA, USA--(Marketwire - Aug. 10, 2009) - Warnex Medical Laboratories, a division of Warnex Inc. (TSX:WNX - News), and Rosetta Genomics, Ltd. (NASDQ:ROSG), the leading developer of microRNA-based molecular diagnostics, announced today they have signed an exclusive distribution agreement in Canada for three currently-available diagnostic tests. Under the terms of the agreement, Warnex will market Rosetta Genomics' miRview(TM) tests. Samples will be sent from Canada to Rosetta Genomics' Philadelphia-based CLIA-certified laboratory for analysis. The terms of the deal were not disclosed.
"We are pleased to add these new tests to our growing portfolio of pharmacogenetic tests," said Mark Busgang, President & CEO of Warnex. "These tests offered by Rosetta Genomics will allow oncologists to accurately trace the origin of the tumour in the body and to better characterize the tissue type, which can lead to a more efficient chemotherapy treatment."
"We are excited to have a well established molecular diagnostic laboratory such as Warnex as our distribution partner in Canada, noted Ronen Tamir, Chief Commercialization Officer at Rosetta Genomics. "Canada is an important market, and this agreement is a significant step as we expand the market for our products in North America. This agreement joins our existing contracts with Prometheus Laboratories in the U.S., and with Teva Pharmaceuticals in Israel and Turkey. We continue in our efforts to expand our global distribution network to other parts of the world, and expect to have additional agreements in place in the near future."
The miRview(TM) tests leverage proprietary microRNA technology developed by Rosetta Genomics, and measure the expression level of specific microRNA biomarkers in tumor samples. The following tests will be distributed by Warnex:
- miRview(TM) mets - This test can accurately identify the primary tumor site in patients presenting with metastatic cancer, as well in patients whose tumor has not been identified, and consequently been labeled Cancer of Unknown Primary (CUP). As metastases need to be treated according to their primary origin, accurate identification of the metastases' primary origin can be critical for determining appropriate treatment. Current diagnostic methods to identify the origin of a metastasis include a wide range of costly, time consuming, and at times inefficient tests. miRview(TM) mets offers physicians a fast, accurate, and easy to interpret diagnosis of the predicted primary origin.
- miRview(TM) squamous - Using a single microRNA, miRview(TM) squamous differentiates squamous from non-squamous, non-small cell lung cancer (NSCLC) patients. When administered targeted therapy, whether currently available or under development, patients with squamous cell carcinoma of the lung have demonstrated varying response patterns ranging from a high incidence of severe or fatal internal bleeding in the lungs to overall poor response to treatment. Current methods for differentiating squamous from non-squamous non-small cell lung cancer are not standardized, are difficult to reproduce, and have low accuracy. miRview squamous produces a single score which indicates whether a sample is squamous or non squamous NSCLC.
- miRview(TM) meso - This test leverages microRNA's high specificity as biomarkers, to differentiate mesothelioma, a cancer connected to asbestos exposure, from other carcinomas in the lung. As mesothelioma patients require specific treatment regimens, accurately diagnosing mesothelioma is critical. Currently, there is no single diagnostic test that is entirely conclusive for this differentiation. In addition, pathological diagnosis may suffer from significant inter-observer variability, and in the absence of a single specific and reliable marker, mesothelioma can be difficult to identify from other cancers. miRview(TM) meso is highly accurate test which may also assist physicians to rule out mesothelioma in patients diagnosed with adenocarcinoma in the lung who have been exposed to mesothelioma-related substances, primarily asbestos particles and heavy metals.
About microRNAs
MicroRNAs (miRNAs) are recently discovered, naturally occurring, small RNAs that act as master regulators and have the potential to form the basis for a new class of diagnostics and therapeutics. Since many diseases are caused by the abnormal activity of proteins, the ability to selectively regulate protein activity through microRNAs could provide the means to treat a wide range of human diseases. In addition, microRNAs have been shown to have different expression in various pathological conditions. As a result, these differences may provide for a novel diagnostic strategy for many diseases.
Approval is coming soon !!!
"On March 23, 2009, Neuromed announced that Exalgo met the primary endpoint in a pivotal phase III clinical trial. On May 22, 2009, Neuromed submitted a response to an Approvable Letter to the U.S. Food and Drug Administration seeking approval for Exalgo for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. On June 12, 2009, the FDA informed Neuromed that the Exalgo submission would be classified as a Complete, Class 2 Response with a corresponding PDUFA date of November 22, 2009."
PDUFA date 22 November 2009
CombinatoRx looks very attractive -
CRXX
MarketCap 67 Mio$
Price 0,95 $
CombinatoRx and Neuromed Sign Merger Agreement
-- Merger to Create a Sustainable Biotechnology Company: Brings Together Significant Product Assets, Unique Discovery Capabilities and Financial Resources –
- Conference Call Scheduled for Today at 8:30am ET -
* Press Release
* Source: CombinatoRx, Incorporated
* On Wednesday July 1, 2009, 7:30 am EDT
CAMBRIDGE, Mass. & VANCOUVER, British Columbia--(BUSINESS WIRE)--CombinatoRx, Incorporated (NASDAQ: CRXX - News) and Neuromed Pharmaceuticals, Inc., a privately-held biopharmaceutical company, today announced they have entered into a definitive merger agreement under which CombinatoRx and Neuromed will merge in an all-stock transaction. Under the terms of the merger agreement, CombinatoRx is expected to issue approximately 36 million new shares of its common stock to Neuromed stockholders with each party owning approximately 50% of the voting power of the merged organization upon closing. Relative ownership of CombinatoRx will then be adjusted based upon the outcome of the FDA’s review of the NDA product candidate, Exalgo™.
Related Quotes
Symbol Price Change
CRXX 0.95 +0.08
Chart for CombinatoRx, Incorporated
{"s" : "crxx","k" : "c10,l10,p20,t10","o" : "","j" : ""}
This merger brings together the product assets and financial resources of both organizations, including potential Exalgo™ milestones and royalty revenue and Neuromed’s proven drug development expertise, with the CombinatoRx portfolio of product candidates and its unique drug discovery capabilities. The rights to Exalgo™, designed to be a once-daily, oral hydromorphone treatment seeking FDA approval for chronic to severe pain, were recently acquired by Mallinckrodt Inc., a subsidiary of Covidien plc, for $15 million in upfront payments, additional development funding of up to $16 million to cover internal and external costs associated with Exalgo, an approval milestone of $30 million, which could potentially increase up to $40 million, and tiered royalties on Exalgo™ net sales after approval. Neuromed has filed a New Drug Application for Exalgo™ with the FDA, which has a November 22, 2009 PDUFA review date.
“By combining forces with Neuromed, we can create a sustainable biotechnology company that has significant product assets, unique discovery capabilities and substantial financial resources. In addition, Christopher Gallen and the rest of the Neuromed management team will bring their considerable product development expertise to bear on the CombinatoRx pipeline and discovery platform. Collectively, the Neuromed team have contributed significantly to more than 10 successful NDAs or other major regulatory submissions and they have launched over 10 pharmaceutical products” said Robert Forrester, Interim President and CEO of CombinatoRx. “Further, this is a unique merger structure, with a contingent valuation element providing downside protection and upside participation for shareholders. This merger with Neuromed will leverage the operational efficiencies created by CombinatoRx’s recent restructuring, including workforce reductions and divestiture of our Singapore subsidiary, to focus on our core technology, simplification of our balance sheet and reduced cash burn going forward. As a result, we expect to have sufficient cash to continue operations into 2012,” concluded Forrester.
“Through this merger with CombinatoRx, we have the opportunity to build a biopharmaceutical organization with a novel approach to drug discovery and development,” commented Christopher Gallen, MD, Ph.D., President and CEO of Neuromed. ”CombinatoRx’s unique discovery approach and the multiple mid- and early-stage product candidates in the CombinatoRx pipeline, combined with Neuromed’s clinical development experience, project management driven culture and ion channel inhibitor programs, will enable the potential creation of new therapeutics. The recent CombinatoRx-Novartis oncology collaboration further recognizes the potential of the CombinatoRx technology by combining the innovative discovery for which Novartis is well known with the systematic exploration of combination therapy made possible by the CombinatoRx platform.”
Details of the Proposed Transaction
Under the terms of the transaction agreements, CombinatoRx will issue shares of common stock to Neuromed stockholders with each party’s pre-merger stockholders owning approximately 50% of the voting power of the merged organization upon closing. Based on the timing of the FDA’s approval decision on Exalgo™, the percentage ownership will be adjusted by issuing shares out of escrow to former Neuromed holders or returning shares from escrow back to CombinatoRx.
* If Exalgo™ approval is received by December 31, 2009, pre-merger CombinatoRx stockholders will own 30% of the combined company.
* If approval is received between January 1, 2010 and September 30, 2010, pre-merger CombinatoRx stockholders will own 40% of the combined company.
* If approval is received between October 1, 2010 and December 31, 2010, pre-merger CombinatoRx stockholders will own 60% of the combined company.
* If approval is not received by December 31, 2010, pre-merger CombinatoRx stockholders will own 70% of the combined company.
The boards of directors of both CombinatoRx and Neuromed have approved the proposed merger transaction, which is subject to customary closing conditions, including receipt of various required approvals from the CombinatoRx and Neuromed stockholders. Subject to customary closing conditions, including receipt of various required approvals from the CombinatoRx and Neuromed stockholders and the effectiveness of an amendment to the organizational documents of Neuromed Canada to facilitate the conversion of its outstanding indebtedness, the transaction is currently expected to close during the fourth quarter of 2009. CombinatoRx stockholders representing approximately 35% of the voting shares of CombinatoRx have already committed to vote in favor of the transaction. Neuromed stockholders representing in excess of 60% of the voting shares of Neuromed have committed to vote in favor of the transaction. Upon closing of the merger, the combined company will have the CombinatoRx name and is expected to trade under the stock symbol (CRXX) on the NASDAQ Global Market. Wedbush Morgan Securities Inc. acted as financial advisor to CombinatoRx in this transaction and JMP Securities acted as exclusive financial advisor to Neuromed. Goodwin Procter served as legal advisors to CombinatoRx and WilmerHale served as legal advisors to Neuromed.
PDUFA date 22 November 2009 .
Time to get in eom !!!
CRXX
MarketCap 70 Mio$
Cash 45 Mio$
Price 0,95 $
CombinatoRx and Neuromed Sign Merger Agreement
-- Merger to Create a Sustainable Biotechnology Company: Brings Together Significant Product Assets, Unique Discovery Capabilities and Financial Resources –
- Conference Call Scheduled for Today at 8:30am ET -
* Press Release
* Source: CombinatoRx, Incorporated
* On Wednesday July 1, 2009, 7:30 am EDT
CAMBRIDGE, Mass. & VANCOUVER, British Columbia--(BUSINESS WIRE)--CombinatoRx, Incorporated (NASDAQ: CRXX - News) and Neuromed Pharmaceuticals, Inc., a privately-held biopharmaceutical company, today announced they have entered into a definitive merger agreement under which CombinatoRx and Neuromed will merge in an all-stock transaction. Under the terms of the merger agreement, CombinatoRx is expected to issue approximately 36 million new shares of its common stock to Neuromed stockholders with each party owning approximately 50% of the voting power of the merged organization upon closing. Relative ownership of CombinatoRx will then be adjusted based upon the outcome of the FDA’s review of the NDA product candidate, Exalgo™.
Related Quotes
Symbol Price Change
CRXX 0.95 +0.08
Chart for CombinatoRx, Incorporated
{"s" : "crxx","k" : "c10,l10,p20,t10","o" : "","j" : ""}
This merger brings together the product assets and financial resources of both organizations, including potential Exalgo™ milestones and royalty revenue and Neuromed’s proven drug development expertise, with the CombinatoRx portfolio of product candidates and its unique drug discovery capabilities. The rights to Exalgo™, designed to be a once-daily, oral hydromorphone treatment seeking FDA approval for chronic to severe pain, were recently acquired by Mallinckrodt Inc., a subsidiary of Covidien plc, for $15 million in upfront payments, additional development funding of up to $16 million to cover internal and external costs associated with Exalgo, an approval milestone of $30 million, which could potentially increase up to $40 million, and tiered royalties on Exalgo™ net sales after approval. Neuromed has filed a New Drug Application for Exalgo™ with the FDA, which has a November 22, 2009 PDUFA review date.
“By combining forces with Neuromed, we can create a sustainable biotechnology company that has significant product assets, unique discovery capabilities and substantial financial resources. In addition, Christopher Gallen and the rest of the Neuromed management team will bring their considerable product development expertise to bear on the CombinatoRx pipeline and discovery platform. Collectively, the Neuromed team have contributed significantly to more than 10 successful NDAs or other major regulatory submissions and they have launched over 10 pharmaceutical products” said Robert Forrester, Interim President and CEO of CombinatoRx. “Further, this is a unique merger structure, with a contingent valuation element providing downside protection and upside participation for shareholders. This merger with Neuromed will leverage the operational efficiencies created by CombinatoRx’s recent restructuring, including workforce reductions and divestiture of our Singapore subsidiary, to focus on our core technology, simplification of our balance sheet and reduced cash burn going forward. As a result, we expect to have sufficient cash to continue operations into 2012,” concluded Forrester.
“Through this merger with CombinatoRx, we have the opportunity to build a biopharmaceutical organization with a novel approach to drug discovery and development,” commented Christopher Gallen, MD, Ph.D., President and CEO of Neuromed. ”CombinatoRx’s unique discovery approach and the multiple mid- and early-stage product candidates in the CombinatoRx pipeline, combined with Neuromed’s clinical development experience, project management driven culture and ion channel inhibitor programs, will enable the potential creation of new therapeutics. The recent CombinatoRx-Novartis oncology collaboration further recognizes the potential of the CombinatoRx technology by combining the innovative discovery for which Novartis is well known with the systematic exploration of combination therapy made possible by the CombinatoRx platform.”
Details of the Proposed Transaction
Under the terms of the transaction agreements, CombinatoRx will issue shares of common stock to Neuromed stockholders with each party’s pre-merger stockholders owning approximately 50% of the voting power of the merged organization upon closing. Based on the timing of the FDA’s approval decision on Exalgo™, the percentage ownership will be adjusted by issuing shares out of escrow to former Neuromed holders or returning shares from escrow back to CombinatoRx.
* If Exalgo™ approval is received by December 31, 2009, pre-merger CombinatoRx stockholders will own 30% of the combined company.
* If approval is received between January 1, 2010 and September 30, 2010, pre-merger CombinatoRx stockholders will own 40% of the combined company.
* If approval is received between October 1, 2010 and December 31, 2010, pre-merger CombinatoRx stockholders will own 60% of the combined company.
* If approval is not received by December 31, 2010, pre-merger CombinatoRx stockholders will own 70% of the combined company.
The boards of directors of both CombinatoRx and Neuromed have approved the proposed merger transaction, which is subject to customary closing conditions, including receipt of various required approvals from the CombinatoRx and Neuromed stockholders. Subject to customary closing conditions, including receipt of various required approvals from the CombinatoRx and Neuromed stockholders and the effectiveness of an amendment to the organizational documents of Neuromed Canada to facilitate the conversion of its outstanding indebtedness, the transaction is currently expected to close during the fourth quarter of 2009. CombinatoRx stockholders representing approximately 35% of the voting shares of CombinatoRx have already committed to vote in favor of the transaction. Neuromed stockholders representing in excess of 60% of the voting shares of Neuromed have committed to vote in favor of the transaction. Upon closing of the merger, the combined company will have the CombinatoRx name and is expected to trade under the stock symbol (CRXX) on the NASDAQ Global Market. Wedbush Morgan Securities Inc. acted as financial advisor to CombinatoRx in this transaction and JMP Securities acted as exclusive financial advisor to Neuromed. Goodwin Procter served as legal advisors to CombinatoRx and WilmerHale served as legal advisors to Neuromed.
PSDV on the move !!!!
Still a big Opportunity eom
Time to buy more !!!
This stock will go much higher very soon !!
Swine-flu stock flying under Radar !
Warnex ( WNX.TO )
MarketCap : 12,86 Mio C$
Cash : 3,5 Mio C$
Price : 0,20 $
Warnex Launches Test for Influenza A H1N1 Virus
* On Tuesday June 2, 2009, 10:05 am EDT
http://finance.yahoo.com/news/Warnex-Launches-Test-for-ccn-860819425.html?x=0&.v=3
Presentation 2009
http://www.warnex.ca/docs/en/corporate/36.Corporate_Presentation_May_2009.pdf
5/12/2009 5:01:40 PM - Market Wire
Record quarterly revenues of $7.6 million and net earnings of $1.1 million
LAVAL, QUEBEC, May 12, 2009 (MARKETWIRE via COMTEX News Network) --
Warnex Inc. (TSX: WNX) today announced its financial results for the first quarter ended March 31, 2009.
Operating Highlights
- Record quarterly revenues of $7.6 million
- Net earnings of $1.1 million compared to a net loss of $0.3 million for the same quarter last year
- EBITDA of $2.0 million
- Cash and cash equivalents totalling $3.1 million
- Launched a new test in the field of personalized medicine: K-ras mutation analysis for patients with colorectal cancer
- Successfully passed a Health Canada inspection of Warnex's analytical facilities in Laval and Blainville
"This quarter, Warnex achieved an all-time quarterly record of $7.6 million in revenues and continued to generate profits and cash flow," said Mark Busgang, President and CEO of Warnex. "This exceptional quarter is the result of some very profitable projects in our Bioanalytical division which began in the last quarter of 2008 and completed during the first quarter of 2009. Going forward, we will continue to focus on improving efficiency and productivity in our operations, delivering earnings and cash flow, and evaluating new business opportunities and potential acquisitions to increase critical mass."
Financial Results
Consolidated revenue for the three-month period ended March 31, 2009, increased by 23% to $7.6 million compared to $6.1 million during the same period last year.
Net earnings for the quarter amounted to $1.1 million or $0.02 per share compared to a net loss of $0.3 million or $0.01 per share for the same quarter in 2008.
Earnings before interest, taxes, depreciation and amortization (EBITDA) for the quarter amounted to $2.0 million versus $0.5 million for the same quarter last year.
Gross margins for the three-month period ended March 31, 2009, amounted to $3.1 million or 41% of sales compared to $1.6 million or 26% of sales for the same quarter last year. The increase of $1.5 million in gross margin is mainly explained by the execution of high margin projects in the Bioanalytical division which began in the last quarter of 2008 and were completed during the first quarter of 2009, as well as a lower amortization expense compared to last year.
Selling and administrative expenses for the three-month period ended March 31, 2009, remained similar to last year at $1.5 million. In proportion of revenue, administrative and selling expenses were lower than last year at 20% in 2009 (2008 - 25%).
Financial expenses decreased by $53,086, from $364,025 in the first quarter of 2008 to $310,939 in the first quarter of 2009, mainly due to less interest following repayments made on the long term debt and debentures.
As of March 31, 2009, the Company had $3.1 million in cash and working capital of $3.0 million.
Very bullish
PSDV was above the 200 day moving average and today crossed the 50 day moving average. This is a very bullish buy signal.
Cheapest biotech stock on Nasdaq
Big news coming soon !
nice move today
up 14% looks good
Phase 3 Data in October
This stock will explode soon eom
Psivida (PSDV)
MarketCap : 31 M$
Cash : 8,02 M$
Price : 1,70$
Shares Out : 18,26 M .... Pfizer is biggest Shareholder (1,9 million shares)
Iluvien™ NDA filing remains on schedule for early calendar 2010
Positive 12 month interim safety and efficacy data from Iluvien PK study
PDSV has two ophthalmic sustained delivery products approved by the FDA for treatment of back of the eye diseases
With our existing partnerships and planned cash burn, we believe we can fund our operations as currently conducted without needing to access the capital markets prior to FDA approval of Iluvien. If approved, we are due to receive a $25 million milestone payment and, once commercialized, a 20% profit share.”
“We are confident in our strategy to capitalize on our core strength of developing drug delivery systems and bringing products to a point where they can be partnered or further developed by the Company,” stated Dr. Paul Ashton, President and CEO of pSivida. “Following the independent Data Safety Monitoring Board’s final review recommending the continuation of the Iluvien Study for the treatment of DME, an NDA filing remains on schedule for early calendar 2010.”
Dr. Ashton noted that the Company’s net cash burn has averaged $1.5 million per quarter during the past six months. “With our existing partnerships and planned cash burn, we believe we can fund our operations as currently conducted without needing to access the capital markets prior to FDA approval of Iluvien. If approved, we are due to receive a $25 million milestone payment and, once commercialized, a 20% profit share.”
An ongoing PK study running concurrently with the pivotal Phase III clinical trials is also designed to provide information on the safety and efficacy of Iluvien in the DME population. Twelve month data from this study was recently presented at the ARVO annual meeting. “We were extremely pleased with the safety and efficacy data from the 12 month PK study readout,” said Dr. Ashton. “There were no adverse events related to IOP (intra ocular pressure) in the low dose patients and even the high dose patients had a lower incidence of IOP compared to the published Retisert DME data. Additionally, the efficacy data continues to be consistent with our expectations.” pSivida’s partner, Alimera Sciences, has worldwide marketing rights to Iluvien.
DME is a potentially blinding disease that affects over one million people in the United States. Currently there are no FDA approved drugs for the treatment of DME.
synthetic heparin nearing approval
US approval within two months eom ...
Alchemia ( ACL.AX )
Marketcap 61 M A$ ( 50 M US$ )
Price 0,38 A$
Alchemia - Fondaparinux ANDA accepted by FDA for Review Mon, 11 May 2009
ASX / Media Release 11 May 2009 Abbreviated New Drug Application for Fondaparinux Accepted by US Food and Drug Administration Brisbane, Australia, 11 May 2009: Australian drug developer, Alchemia Limited (ASX:ACL), today announced that its global manufacturing and U.S. marketing partner Dr Reddy’s Laboratories (NYSE:RDY) has received notice of acceptance of its Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (FDA) for Fondaparinux Sodium. Dr Reddy’s filed the ANDA in March 2009 and this notice of acceptance indicates that the ANDA will now enter a period of formal review.
Being the first generic version of fondaparinux, the application has been marked for priority review under FDA’s Generic Initiative for Value and Efficiency (the GIVE initiative). First generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. The manufacturing process for fondaparinux used by Dr Reddy’s utilizes a novel, synthetic pathway developed by Alchemia.
About Abbreviated New Drug Applications (ANDA) According to the FDA’s Center for Drug Evaluation and Research (CDER), an ANDA contains data that provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product as an alternative to the branded drug. A generic drug product is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.
Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical and clinical data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is equivalent to the branded drug. About Alchemia Limited – www.alchemia.com.au Alchemia is a drug discovery and development company founded on its chemistry expertise.
The Company’s lead program is fondaparinux (synthetic heparin, a generic version of GlaxoSmithKline’s Arixtra®) which is expected to generate near term revenues for the company and is partnered with Dr Reddy’s Laboratories Inc. for the U.S. market.
Alchemia’s pipeline of assets is built on two platform technologies: HyACT® (targeted cancer delivery) and VASTTM (drug discovery). HA-irinotecan, for the treatment of colorectal cancer, recently achieved positive Phase II clinical trial results. Arixtra® is a registered trademark of GlaxoSmithKline.
BNC.TO ..Outperform Rating
http://www.haywood.com/pdffiles/BNCJul142009.pdf
SECTOR OUTPERFORM; Target: (+$0.20) $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 $0.50/shr. We note the US$20M upfront from the Endo
agreement is worth ~$0.25/shr alone. We disagree with the market that
the Human Health division with Urocidin is currently worth zero to BNC
and investors.
BNC.TO ..Outperform Rating
http://www.haywood.com/pdffiles/BNCJul142009.pdf
SECTOR OUTPERFORM; Target: (+$0.20) $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 $0.50/shr. We note the US$20M upfront from the Endo
agreement is worth ~$0.25/shr alone. We disagree with the market that
the Human Health division with Urocidin is currently worth zero to BNC
and investors.
Great Interview...
http://ceocfointerviews.com/interviews/MSBT-MedaSorb.htm
Upcoming Milestones
Bladder Cancer PIII update in July 2009
Econiche Vaccine (E.coli) US approval in August or September 2009
BNC.TO
Marketcap 43 Mio $
Cash 28 Mio &
Price 0,50 $
This stock is a Gift at this price ...
Great Article ..
http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=51437
Bioniche to Get up to $130M in Urology Deal with Endo
By Catherine Hollingsworth
Staff Writer
Canadian biopharmaceutical firm Bioniche Life Sciences Inc. has entered a urology drug deal with U.S-based Endo Pharmaceuticals worth up to $130 million, essentially eliminating the company's cash burn for its bladder cancer program.
Belleville, Ontario-based Bioniche generates revenue from its animal health business, and on the human health side its cash burn "is pretty much, well, it is eliminated" for bladder cancer," Graeme McRae, chairman, president and CEO of Bioniche, told BioWorld Today.
The company's future cash burn would depend on whether Chadds Ford, Pa.-based Endo decides to develop additional indications beyond bladder cancer, he noted.
Under the deal, Endo will develop and market Bioniche's Phase III bladder cancer product, Urocidin, and make an up-front cash payment of $20 million and up to $110 million in potential milestone payments.
Bioniche will be responsible for manufacturing Urocidin, aimed at patients who have not responded or stopped responding to an existing treatment known as BCG, short hand for the vaccine bacilli Calmette-Guerin.
Originally developed in the 1920s for tuberculosis, the live BCG vaccine also is used to activate the immune system against bladder cancer. But treatment with BCG can be irritating to the bladder and, in a small number of cases, can result in TB infection.
The up-front payment will be used for working capital, as Bioniche seeks to reduce its bank debt and makes plans for the next potential indication using its Mycobacterial Cell Wall - DNA complex (MCC) technology. Urocidin is the product developed from the technology.
Under the agreement, Endo has the first right of refusal of other pelvic cancer indications based on that technology. Bioniche has done preliminary work in cervical and ovarian cancer and has completed Phase I testing in prostate cancer.
In addition, Bioniche has completed enrollment for the first Phase III trial of Urocidin, the results of which are expected in April 2010 and will be made publicly available in May 2010. That trial is in patients who are refractory to treatment with BCG.
A second trial of Urocidin is expected to start at the end of the year in patients with newly diagnosed bladder cancer who are at high risk of the disease progressing or recurring. The 800-patient study is expected to complete enrollment in two years, followed by a two-year observation period.
The indications being studied in those trials have been granted fast-track status by the FDA.
Cowen & Co. analyst Ian Sanderson, who tracks Endo, said in a research note that if the Phase III studies succeed, "we project a late 2011 filing and 2012 launch for Urocidin." But Sanderson said that Endo needs to make some more moves to offset the potential loss of its Lidoderm and Opana franchise sales to generic competition between 2012 and 2015.
Phase II results for Urocidin showed that 40 percent to 60 percent of patients who failed the existing therapy achieved a complete response. If Urocidin can achieve a 20 percent response rate in the refractory population, it "will probably be very well accepted" by the FDA, McRae said.
So far, the safety profile has been clean and study patients have not dropped out due to side effects. One reason no new treatments have emerged for bladder cancer is that it is difficult to treat without making the symptoms worse.
While chemotherapy has been tried off-label to treat bladder cancer, the process can be irritating to the bladder. The chemo requires a lengthy period of contact with a tumor to work, but urine in the bladder can dilute the chemo and maintaining the chemo in the bladder for more than hour is a challenge.
Urocidin, on the other hand, is designed to work in 30 minutes and can be maintained at an effective level even with the dilutive effect of urine, McRae explained.
He said only a handful of companies are working on new treatments for bladder cancer using chemotherapy or toxins bound to antibodies. But Bioniche's product candidate is the most advanced and has what McRae called the "crème de la crème of urologists" in its clinical program who hail from top medical institutions such as Memorial Sloan Kettering and Johns Hopkins.
Prior to the deal with Endo, Urocidin was the only advanced product in the urology area that still was unpartnered, McRae noted. Bioniche had been in discussion with multinational companies that claimed to be in the urology space, "but weren't really," he said, adding that he was surprised by the lack of understanding of the field.
Endo had purchased the urology company Indevus, a move that McRae said, "clearly steered Endo toward us." He said Endo and Bioniche had "a lot of synergy" between their clinical and research groups.
In August, Endo plans to launch Valstar for BCG-refractory bladder cancer, David Holveck, president and CEO of Endo said in a statement. "If successful in clinical development, Urocidin has the potential to extend and enhance our recent therapeutic expansion and strengthen the Valstar franchise," Holveck said.
About 70,000 patients in the U.S. are 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.
About 70 percent of bladder cancer patients have the non-muscle-invasive form of bladder cancer at diagnosis and potentially could be eligible for multiple treatments with Urocidin, if approved, according to Bioniche.
Shares in Bioniche (TSX:BNC) were up C12 cents or 26 percent, closing at C58 cents. Shares in Endo (NASDAQ:ENDP) were down 25 cents, closing at $17.09.
Published July 13, 2009
BNC.TO ..Great Article
This Stock is still a big Opportunity ..
http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=51437
Bioniche to Get up to $130M in Urology Deal with Endo
By Catherine Hollingsworth
Staff Writer
Canadian biopharmaceutical firm Bioniche Life Sciences Inc. has entered a urology drug deal with U.S-based Endo Pharmaceuticals worth up to $130 million, essentially eliminating the company's cash burn for its bladder cancer program.
Belleville, Ontario-based Bioniche generates revenue from its animal health business, and on the human health side its cash burn "is pretty much, well, it is eliminated" for bladder cancer," Graeme McRae, chairman, president and CEO of Bioniche, told BioWorld Today.
The company's future cash burn would depend on whether Chadds Ford, Pa.-based Endo decides to develop additional indications beyond bladder cancer, he noted.
Under the deal, Endo will develop and market Bioniche's Phase III bladder cancer product, Urocidin, and make an up-front cash payment of $20 million and up to $110 million in potential milestone payments.
Bioniche will be responsible for manufacturing Urocidin, aimed at patients who have not responded or stopped responding to an existing treatment known as BCG, short hand for the vaccine bacilli Calmette-Guerin.
Originally developed in the 1920s for tuberculosis, the live BCG vaccine also is used to activate the immune system against bladder cancer. But treatment with BCG can be irritating to the bladder and, in a small number of cases, can result in TB infection.
The up-front payment will be used for working capital, as Bioniche seeks to reduce its bank debt and makes plans for the next potential indication using its Mycobacterial Cell Wall - DNA complex (MCC) technology. Urocidin is the product developed from the technology.
Under the agreement, Endo has the first right of refusal of other pelvic cancer indications based on that technology. Bioniche has done preliminary work in cervical and ovarian cancer and has completed Phase I testing in prostate cancer.
In addition, Bioniche has completed enrollment for the first Phase III trial of Urocidin, the results of which are expected in April 2010 and will be made publicly available in May 2010. That trial is in patients who are refractory to treatment with BCG.
A second trial of Urocidin is expected to start at the end of the year in patients with newly diagnosed bladder cancer who are at high risk of the disease progressing or recurring. The 800-patient study is expected to complete enrollment in two years, followed by a two-year observation period.
The indications being studied in those trials have been granted fast-track status by the FDA.
Cowen & Co. analyst Ian Sanderson, who tracks Endo, said in a research note that if the Phase III studies succeed, "we project a late 2011 filing and 2012 launch for Urocidin." But Sanderson said that Endo needs to make some more moves to offset the potential loss of its Lidoderm and Opana franchise sales to generic competition between 2012 and 2015.
Phase II results for Urocidin showed that 40 percent to 60 percent of patients who failed the existing therapy achieved a complete response. If Urocidin can achieve a 20 percent response rate in the refractory population, it "will probably be very well accepted" by the FDA, McRae said.
So far, the safety profile has been clean and study patients have not dropped out due to side effects. One reason no new treatments have emerged for bladder cancer is that it is difficult to treat without making the symptoms worse.
While chemotherapy has been tried off-label to treat bladder cancer, the process can be irritating to the bladder. The chemo requires a lengthy period of contact with a tumor to work, but urine in the bladder can dilute the chemo and maintaining the chemo in the bladder for more than hour is a challenge.
Urocidin, on the other hand, is designed to work in 30 minutes and can be maintained at an effective level even with the dilutive effect of urine, McRae explained.
He said only a handful of companies are working on new treatments for bladder cancer using chemotherapy or toxins bound to antibodies. But Bioniche's product candidate is the most advanced and has what McRae called the "crème de la crème of urologists" in its clinical program who hail from top medical institutions such as Memorial Sloan Kettering and Johns Hopkins.
Prior to the deal with Endo, Urocidin was the only advanced product in the urology area that still was unpartnered, McRae noted. Bioniche had been in discussion with multinational companies that claimed to be in the urology space, "but weren't really," he said, adding that he was surprised by the lack of understanding of the field.
Endo had purchased the urology company Indevus, a move that McRae said, "clearly steered Endo toward us." He said Endo and Bioniche had "a lot of synergy" between their clinical and research groups.
In August, Endo plans to launch Valstar for BCG-refractory bladder cancer, David Holveck, president and CEO of Endo said in a statement. "If successful in clinical development, Urocidin has the potential to extend and enhance our recent therapeutic expansion and strengthen the Valstar franchise," Holveck said.
About 70,000 patients in the U.S. are 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.
About 70 percent of bladder cancer patients have the non-muscle-invasive form of bladder cancer at diagnosis and potentially could be eligible for multiple treatments with Urocidin, if approved, according to Bioniche.
Shares in Bioniche (TSX:BNC) were up C12 cents or 26 percent, closing at C58 cents. Shares in Endo (NASDAQ:ENDP) were down 25 cents, closing at $17.09.
Published July 13, 2009
US approval in 4Q 2009 ??
I hope so ..
http://reports.finance.yahoo.com/w0?r=45713429:2
Developments Intelgenx announced that the FDA has finished its preliminary review and accepted Intelgenx’s NDA filing for CPI-300, a 450mg extended release Bupropion tablet. Impact Positive. Intelgenx is keeping to its timeline and we should see the tablet approved by Q4/09 and on the market by Q1/10. Comments The FDA has begun its full review of Intelgenx’s 450mg Bupropion tablet, which is excellent news for the company and maintains their timeline.
US approval in 4Q 2009 ??
I hope so ...
http://reports.finance.yahoo.com/w0?r=45713429:2
Developments Intelgenx announced that the FDA has finished its preliminary review and accepted Intelgenx’s NDA filing for CPI-300, a 450mg extended release Bupropion tablet. Impact Positive. Intelgenx is keeping to its timeline and we should see the tablet approved by Q4/09 and on the market by Q1/10. Comments The FDA has begun its full review of Intelgenx’s 450mg Bupropion tablet, which is excellent news for the company and maintains their timeline.
US approval in 4Q 2009 ??
http://reports.finance.yahoo.com/w0?r=45713429:2
Developments Intelgenx announced that the FDA has finished its preliminary review and accepted Intelgenx’s NDA filing for CPI-300, a 450mg extended release Bupropion tablet. Impact Positive. Intelgenx is keeping to its timeline and we should see the tablet approved by Q4/09 and on the market by Q1/10. Comments The FDA has begun its full review of Intelgenx’s 450mg Bupropion tablet, which is excellent news for the company and maintains their timeline.
Fantastic News boooyaahhh
Bioniche Life Sciences Inc. and Endo Pharmaceuticals Inc. Sign Licensing Agreement for Urocidin(TM)
7/10/2009 8:00 AM - Canada NewsWire
BELLEVILLE, ON and CHADDS FORD, PA, Jul 10, 2009 (Canada NewsWire via COMTEX News Network) --
Bioniche Life Sciences Inc. (TSX: BNC) and Endo Pharmaceuticals Inc. (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 BCG-refractory 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.
Great news for Bioniche Life Science
wooohhooooooohooo
Bioniche Life Sciences Inc. and Endo Pharmaceuticals Inc. Sign Licensing Agreement for Urocidin(TM)
7/10/2009 8:00 AM - Canada NewsWire
BELLEVILLE, ON and CHADDS FORD, PA, Jul 10, 2009 (Canada NewsWire via COMTEX News Network) --
Bioniche Life Sciences Inc. (TSX: BNC) and Endo Pharmaceuticals Inc. (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 BCG-refractory 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.
CMO is optimistic for MCC in Bladder Cancer
An interview with Dr. Francois Charette, Chief Medical Officer at Bioniche Life Sciences Inc.
What is a clinical trial?
Clinical trials or clinical studies test potential treatments to see if they are effective and safe. New products must be studied in laboratory animals first to evaluate potential toxicity before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise are then moved into clinical trials. Clinical trials are an integral part of new product discovery and development, and are required by regulatory authorities before a new product can be commercialized.
Why participate in a clinical trial?
People volunteer to participate in clinical trials for different reasons. Many volunteer because they want to help advance medical knowledge. Others have tried all available treatments for their condition without success. Although efforts are made to control risks to clinical trial participants, some risk may be unavoidable because of the uncertainty inherent in clinical research involving new medical treatments. I have a lot of respect for participants. Without their contribution, we would not be able to develop new products.
Who can participate?
It's important to test new treatments in the people they are meant to help. Trial guidelines, or eligibility requirements, are developed by the researchers and usually include criteria for age, sex, type and stage of disease, previous treatment history, and other medical conditions. Some trials involve people with a particular illness or condition to be studied, while others seek healthy volunteers. Inclusion or exclusion criteria help identify appropriate participants and help to exclude those who may be put at risk by participating in a trial.
What happens in a clinical trial?
Every clinical trial is designed to answer certain research questions. A trial plan called a "protocol" maps out what study procedures will be done, by whom, and why. The clinical trial team includes doctors and nurses as well as other health care professionals. This team checks the health of the participant at the beginning of the trial and assesses whether that person is eligible to participate. Those found to be eligible - and who agree to participate - are given specific instructions, and then monitored and carefully assessed during the trial and after it is completed.
Is Bioniche currently conducting clinical trials?
Bioniche is currently conducting a clinical trial in bladder cancer with Mycobacterial Cell Wall-DNA Complex (MCC). MCC is a formulation of cell wall fragments from a type of mycobacterium which is found in soil, on plants, and in drinking water and which does not cause disease. It contains no animal or preservative by-product, thereby decreasing the risk of any harmful or allergic reactions. MCC is a sterile product, which means that there are no live organisms in the preparation.
What is involved in running the clinical program with MCC for patients with bladder cancer?
Our first priority in organizing a study for patients with bladder cancer is to make sure that everyone is treated safely with an opportunity of obtaining good results in their treatment against cancer. We write up protocols in collaboration with the top world expert urologists and then collaborate with clinical centres that have the experience in dealing with products under investigation. All centres must receive approval from an Ethical Review Board (ERB) before starting to recruit patients.
What is the design of the first trial that is underway?
One problem in the treatment of bladder cancer is that not everyone can be cured with the available medication. Even if the cancer is still superficial (it has not entered into the wall of the bladder), it is not easy to take out or to treat with drugs that are put in the bladder. Our first trial is for patients that have not responded to a medication called Bacillus Calmette-Guérin (BCG). There are not many options available for these patients. Many of them eventually need to have their bladder removed (a procedure called a cystectomy). We hope that MCC will be able to take care of some of the bladder cancers that have not done well with BCG.
How are patients identified for this trial?
We work very closely with 25 urology centres in North America (Canada and the U.S.). Urologists from these centres propose this product under investigation to the patients that have not done well with BCG. Other patients will, after learning by themselves about MCC, contact us or their urologist to find out if they are eligible for this experimental treatment. They can then be eventually referred to a research site.
When will the first trial be completed?
We anticipate that recruitment in the first trial will be completed by mid-2008. The target is to enroll 105 patients.
How can someone get additional information about this trial?
There are different ways to obtain more information on this trial. Our study is listed on the website www.clinicaltrials.gov. This website provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The National Health Institute (NIH), through its National Library of Medicine, has developed this site in collaboration with all NIH institutes and the FDA.
For more information about the MCC clinical program, please contact Bioniche Therapeutics at 1-800-567-2028 or clinicaltrials@bioniche.com.
When will the results of the first trial be submitted for review by the FDA?
We will follow the patients of this first trial for five years, but will submit results to the FDA after all patients have been in the study for a minimum of one year.
Are you able to discuss the results that you are seeing in the first trial?
We cannot discuss results before the study is completed. The reason for this is to reduce bias (patients or physicians beginning to think that the product is effective or not) before the study results are analyzed. However, during the trial, there is a committee that is independent from our Company that will look at the results regularly to make sure that everything is going well and that there is limited risk for the patients. This committee is called the Data Safety Monitoring Board.
Will the results be available to the patients/public?
We are committed to make the results of all of our trials public. They will be presented at scientific meetings and there will be press releases to announce the results to everyone.
Will the second trial start before the first one ends?
We expect to begin our second trial in the first quarter of 2008, before the first trial ends.
What is the design of that trial?
The second trial will be for all patients that have a superficial (also known as non-invasive) bladder cancer that is at high risk of recurring (coming back) after surgery or at high risk of progression (that may invade the bladder wall). These are usually high grade cancers, which means cancers that are somewhat more dangerous than other types of bladder cancers (low grade). The usual treatment for these cancers after tentative complete surgical removal is to instill (put in the bladder through a small tube) a product called Bacillus Calmette-Guérin (BCG). This treatment is effective most of the time, but there are also patients for whom it is not effective. Many patients have difficulty tolerating this treatment in particular because BCG is a live microbe, a mycobacterium that causes an infection in the bladder. The second trial will compare our product to BCG. At this time, we think that MCC is as good as BCG to support the cure of the patient, but will be better tolerated, with fewer side effects.
What is your expectation for the two Phase III trials with MCC?
I am optimistic that we will be able to show that MCC is an effective and safe product for the treatment of bladder cancer. There is an unmet need for new, better and safer therapies for bladder cancer and I hope we will meet the challenge of addressing this need.
What can you tell us about the Bioniche Therapeutics clinical group?
We have a great team working diligently to advance the science and demonstrate the clinical value of new treatments. The group has considerable expertise in developing new products and strong academic credentials. Moreover, these men and women are dedicated to making it all happen and take pride in their efforts to bring a new product to bladder cancer patients.
Other than bladder cancer, what is the focus for the Bioniche Therapeutics clinical group?
The team will also be looking at the possibility of treating other cancers using the MCC product. The development for these other cancers is much less advanced. There is however, once again, the possibility of advancing medical science for the benefit of patients. This keeps the group very motivated.
re Cancer drug PIII Update + US approval soon
CMO is optimistic for MCC in Bladder Cancer
An interview with Dr. Francois Charette, Chief Medical Officer at Bioniche Life Sciences Inc.
What is a clinical trial?
Clinical trials or clinical studies test potential treatments to see if they are effective and safe. New products must be studied in laboratory animals first to evaluate potential toxicity before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise are then moved into clinical trials. Clinical trials are an integral part of new product discovery and development, and are required by regulatory authorities before a new product can be commercialized.
Why participate in a clinical trial?
People volunteer to participate in clinical trials for different reasons. Many volunteer because they want to help advance medical knowledge. Others have tried all available treatments for their condition without success. Although efforts are made to control risks to clinical trial participants, some risk may be unavoidable because of the uncertainty inherent in clinical research involving new medical treatments. I have a lot of respect for participants. Without their contribution, we would not be able to develop new products.
Who can participate?
It's important to test new treatments in the people they are meant to help. Trial guidelines, or eligibility requirements, are developed by the researchers and usually include criteria for age, sex, type and stage of disease, previous treatment history, and other medical conditions. Some trials involve people with a particular illness or condition to be studied, while others seek healthy volunteers. Inclusion or exclusion criteria help identify appropriate participants and help to exclude those who may be put at risk by participating in a trial.
What happens in a clinical trial?
Every clinical trial is designed to answer certain research questions. A trial plan called a "protocol" maps out what study procedures will be done, by whom, and why. The clinical trial team includes doctors and nurses as well as other health care professionals. This team checks the health of the participant at the beginning of the trial and assesses whether that person is eligible to participate. Those found to be eligible - and who agree to participate - are given specific instructions, and then monitored and carefully assessed during the trial and after it is completed.
Is Bioniche currently conducting clinical trials?
Bioniche is currently conducting a clinical trial in bladder cancer with Mycobacterial Cell Wall-DNA Complex (MCC). MCC is a formulation of cell wall fragments from a type of mycobacterium which is found in soil, on plants, and in drinking water and which does not cause disease. It contains no animal or preservative by-product, thereby decreasing the risk of any harmful or allergic reactions. MCC is a sterile product, which means that there are no live organisms in the preparation.
What is involved in running the clinical program with MCC for patients with bladder cancer?
Our first priority in organizing a study for patients with bladder cancer is to make sure that everyone is treated safely with an opportunity of obtaining good results in their treatment against cancer. We write up protocols in collaboration with the top world expert urologists and then collaborate with clinical centres that have the experience in dealing with products under investigation. All centres must receive approval from an Ethical Review Board (ERB) before starting to recruit patients.
What is the design of the first trial that is underway?
One problem in the treatment of bladder cancer is that not everyone can be cured with the available medication. Even if the cancer is still superficial (it has not entered into the wall of the bladder), it is not easy to take out or to treat with drugs that are put in the bladder. Our first trial is for patients that have not responded to a medication called Bacillus Calmette-Guérin (BCG). There are not many options available for these patients. Many of them eventually need to have their bladder removed (a procedure called a cystectomy). We hope that MCC will be able to take care of some of the bladder cancers that have not done well with BCG.
How are patients identified for this trial?
We work very closely with 25 urology centres in North America (Canada and the U.S.). Urologists from these centres propose this product under investigation to the patients that have not done well with BCG. Other patients will, after learning by themselves about MCC, contact us or their urologist to find out if they are eligible for this experimental treatment. They can then be eventually referred to a research site.
When will the first trial be completed?
We anticipate that recruitment in the first trial will be completed by mid-2008. The target is to enroll 105 patients.
How can someone get additional information about this trial?
There are different ways to obtain more information on this trial. Our study is listed on the website www.clinicaltrials.gov. This website provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The National Health Institute (NIH), through its National Library of Medicine, has developed this site in collaboration with all NIH institutes and the FDA.
For more information about the MCC clinical program, please contact Bioniche Therapeutics at 1-800-567-2028 or clinicaltrials@bioniche.com.
When will the results of the first trial be submitted for review by the FDA?
We will follow the patients of this first trial for five years, but will submit results to the FDA after all patients have been in the study for a minimum of one year.
Are you able to discuss the results that you are seeing in the first trial?
We cannot discuss results before the study is completed. The reason for this is to reduce bias (patients or physicians beginning to think that the product is effective or not) before the study results are analyzed. However, during the trial, there is a committee that is independent from our Company that will look at the results regularly to make sure that everything is going well and that there is limited risk for the patients. This committee is called the Data Safety Monitoring Board.
Will the results be available to the patients/public?
We are committed to make the results of all of our trials public. They will be presented at scientific meetings and there will be press releases to announce the results to everyone.
Will the second trial start before the first one ends?
We expect to begin our second trial in the first quarter of 2008, before the first trial ends.
What is the design of that trial?
The second trial will be for all patients that have a superficial (also known as non-invasive) bladder cancer that is at high risk of recurring (coming back) after surgery or at high risk of progression (that may invade the bladder wall). These are usually high grade cancers, which means cancers that are somewhat more dangerous than other types of bladder cancers (low grade). The usual treatment for these cancers after tentative complete surgical removal is to instill (put in the bladder through a small tube) a product called Bacillus Calmette-Guérin (BCG). This treatment is effective most of the time, but there are also patients for whom it is not effective. Many patients have difficulty tolerating this treatment in particular because BCG is a live microbe, a mycobacterium that causes an infection in the bladder. The second trial will compare our product to BCG. At this time, we think that MCC is as good as BCG to support the cure of the patient, but will be better tolerated, with fewer side effects.
What is your expectation for the two Phase III trials with MCC?
I am optimistic that we will be able to show that MCC is an effective and safe product for the treatment of bladder cancer. There is an unmet need for new, better and safer therapies for bladder cancer and I hope we will meet the challenge of addressing this need.
What can you tell us about the Bioniche Therapeutics clinical group?
We have a great team working diligently to advance the science and demonstrate the clinical value of new treatments. The group has considerable expertise in developing new products and strong academic credentials. Moreover, these men and women are dedicated to making it all happen and take pride in their efforts to bring a new product to bladder cancer patients.
Other than bladder cancer, what is the focus for the Bioniche Therapeutics clinical group?
The team will also be looking at the possibility of treating other cancers using the MCC product. The development for these other cancers is much less advanced. There is however, once again, the possibility of advancing medical science for the benefit of patients. This keeps the group very motivated.
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Approval for their E.coli Vaccine not Cancer drug
http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2009/07/02/MND818HANH.DTL
"While Epitopix may have the first product of its kind in the United States, others have plans to follow. Bioniche Life Sciences Inc. of Canada is also working on getting a USDA conditional license for a vaccine and hopes to have approval by August or September, said Gary Weber, president of food and safety for the firm's U.S. division. "
Cancer drug PIII Update + US approval soon
Up 20% today ..
Bioniche Life Science (BNC.TO)
MarketCap 33 Mio C$
Price 0,38 C$
Upcoming Milestones :
Bladder Cancer PIII Update in July
US approval for E.coli Vaccine in August or September 2009
Econiche - World's First Cattle Vaccine to Reduce E. coli O157 Gets Approval in Canada
http://www.scientificblogging.com/news_releases/econiche_worlds_first_cattle_vaccine_reduce_e_coli_o157_gets_approval_canada
http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2009/07/02/MND818HANH.DTL
"While Epitopix may have the first product of its kind in the United States, others have plans to follow. Bioniche Life Sciences Inc. of Canada is also working on getting a USDA conditional license for a vaccine and hopes to have approval by August or September, said Gary Weber, president of food and safety for the firm's U.S. division. "
Bioniche Phase III Clinical Trial with Urocidin(TM) Progressing Well
* Press Release
* Source: Bioniche Life Sciences Inc.
* On Friday May 22, 2009, 4:00 pm EDT
*
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BELLEVILLE, ON, May 22 /CNW/ - 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 Urocidin(TM) in the treatment of bladder cancer. On March 31st, the Company announced that recruitment had been completed in its initial 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 Safety Monitoring Committee (DSMC) held its eighth meeting regarding this clinical trial earlier this 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 July.
The DSMC 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. On a regular basis, the DSMC reviews study results, evaluates the incidence of adverse events, determines whether the basic trial assumptions remain valid, and evaluates whether the overall integrity, scientific merit and conduct of the study remain acceptable.
Data from the full cohort of 105 high-grade bladder cancer patients from this trial, coupled with additional safety information to be collected from a second clinical trial that is expected to start later this year, will be used to support regulatory submissions under the FDA's Accelerated Approval program.
Second Phase III Registration Trial
Bioniche plans to conduct a second registration trial that will directly compare the efficacy and safety of Urocidin with BCG in the first-line treatment of non-muscle-invasive bladder cancer. In September, 2007, the Company 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 Urocidin when the trial endpoints are achieved. This indication for MCC received Fast Track designation by the FDA last year. The Company expects to start this trial at such time as it has a development and marketing partner in place.
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FDA accept NDA filing for Antidepressant !
Marketcap only 10 M$ eom
IntelGenx Corp. Announces FDA Acceptance for Filing of NDA for CPI-300 Antidepressant
On Tuesday June 23, 2009, 6:00 am EDT
IntelGenx Corp. (TSX-V: IGX)(OTC.BB: IGXT) ("IntelGenx") today announced that the New Drug Application filing for their antidepressant CPI-300 has been accepted by the U.S. Food and Drug Administration (FDA) for standard review. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, IntelGenx expects the FDA will complete its review or otherwise respond to the NDA by February 6, 2010.
"Formal FDA acceptance of the NDA clears the path towards review and approval of CPI-300 within the timeframe expected" said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "We are especially pleased to note that the FDA has confirmed that our NDA was sufficiently complete to permit a substantive review. As CPI-300 represents our very first NDA, this is not only a testament to the expertise of our staff but also to the strength of our partners."
IntelGenx and Cary Pharmaceuticals Inc. entered into a Collaborative Agreement in November 2007 to jointly develop and commercialize CPI-300 using IntelGenx's proprietary oral delivery technology. Under the terms of the Collaborative Agreement, IntelGenx raised $2 million in March 2008 to fund completion of the product development and Cary Pharmaceuticals Inc. acted as the applicant for the submission of the NDA. Upon commercialization of the product, IntelGenx and Cary Pharmaceuticals Inc. would share profits.