Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
FDA accept NDA filing for Antidepressant
Great News
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 $2 million in March 2008 to fund completion of the product development and Cary Pharmaceuticals Inc. acted as the applicant for the submission of the NDA. Upon commercialization of the product, IntelGenx and Cary Pharmaceuticals Inc. would share profits.
re IGXT ..Profitable by next year !!!!
http://www.intelgenx.com/_assets/pdf/Intelgenx-Presentation-2009.pdf
IGXT.OB = Multibagger Potential +++
This stock is vertualy unknown to investors. If you do your homework, you will clearly see that this stock will rise rapidly as soon as it gets noticed.
This is a real sleeper !!!! Please do your own Research .
Intelgenx Technologies (IGXT.OB)
MarketCap : 10,3 Mio US$
Price : 0,51 $
Shares Out : 20,85 M
Check out their fantastic Pipeline !
http://www.intelgenx.com/products/pipeline.html
Insider activity
http://finance.yahoo.com/q/it?s=IGXT.OB
RECENT OPERATIONAL HIGHLIGHTS ( May 2009)
- Filed NDA with U.S. Food and Drug Administration (FDA) - IntelGenx and Cary Pharmaceuticals filed a New Drug Application (NDA) under CFR 21 section 505(b)(2) for the CPI-300 antidepressant. CPI-300 is a new strength of a leading antidepressant that will provide a more convenient dosing option to patients with major depressive disorder ("MDD").
IntelGenx and Cary Pharmaceuticals 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 acted as the applicant for the submission of the NDA. Upon commercialization of the product, IntelGenx and Cary Pharmaceuticals would share profits.
- Earned Royalty Revenue for the first time in Company's History - IntelGenx earned royalty revenues of approximately $42.9 thousand in Q1, 2009 in respect of commercial activities in November and December 2008. Royalty revenues were earned from commercialization of the first product fully-developed by the Company, a prenatal multivitamin supplement marketed as Gesticare® in the USA, which was commercialized in November 2008.
- Announced Positive Phase 1(b) Clinical Study Results for Relivar - IntelGenx and Cannasat Therapeutics Inc., announced positive results for the Phase 1(b) clinical trial of Relivar, the first buccal dronabinol drug delivery product, which was developed using IntelGenx' proprietary AdVersa buccal delivery technology. Buccal delivery allows for drug absorption from the mouth directly into the bloodstream as opposed to the intestinal tract absorption seen with oral tablet technologies.
In this clinical trial, Relivar delivered twice the amount of dronabinol into the bloodstream versus the reference drug Marinol (as measured by AUC) with no increase in adverse events.
- Signed New Partnership Agreement with European Pharmaceutical Company - IntelGenx announced a new partnership with Circ Pharma Limited, a specialty pharmaceutical company based in Ireland, to develop and commercialize a novel drug for the treatment of hyperlipidemia.
In accordance with the Agreement, IntelGenx will be responsible for the formulation, manufacture and supply to Circ Pharma of the drug product. Circ Pharma will be responsible for commercialization of the product. Circ Pharma will fund the development of the product and IntelGenx will receive royalties from the product's sales.
In announcing the results, Horst Zerbe, President and Chief Executive Officer of IntelGenx, said:
"In the first few months of 2009 IntelGenx has already achieved a number of notable firsts in our corporate history: the 505(b)(2) NDA for the CPI-300 antidepressant was filed, and, for the first time, we earned sales and manufacturing royalties on the first product fully-developed by the Company.
What a great opportunity !!!!!
Analyst Report from March 2009
INTELGENX TECHNOLOGIES CORP. Price: $0.50
Date | March 26, 2009 Target: $ 2.25
SPECULATIVE BUY
• Sales of IntelGenx’ first product (pre-natal vitamins) using
the Company’s proprietary Versatab technology began in the
fourth quarter.
• The Company reported revenues of $0.98 mm, an increase of
13% over the previous year, and a net loss of $2.8 mm, an
increase of 155%.
• The Company has $0.83 mm in cash remaining, of which
$0.28 mm is restricted. We believe this represents 6-10
months of operations, depending on the success of sales of
its pre-natal vitamin.
• The Company has taken somewhat longer than expected to
file their NDA application, so we have adjusted our model to
reflect sales beginning a quarter later than we had expected.
• We are maintaining a Speculative Buy rating and reducing
our target to $2.25 from $2.50.
IMPACT:
Neutral. Sales of IntelGenx’ first product (pre-natal vitamins) using the
Company’s proprietary Versatab technology began in the fourth quarter and the
Company is very close to filing a 505(b)(2) NDA application with the FDA for its
lead product anti-depressant CPI-300.
DETAILS:
IntelGenx has $833,219 in cash (as of Dec 2008), of which $277,220 is restricted for
product development with partners. The Company had a cash burn of
$1,737,032. We estimate that the Company has 6-10 months of cash remaining
depending on how fast the pre-natal vitamin sales build. The vitamins were
launched in Q4/08, but we will only see initial revenue in Q1/09 results.
The Company is very close to filing an NDA for their Anti-depressant drug CPI-
330, which is being developed with Cary Pharmaceuticals. This will be its first
major product, and could be approved and marketed by the end of this year.
The Company has taken somewhat longer than expected to file their NDA
application, so we have adjusted our model to reflect sales beginning a quarter
later than we had expected.
RECOMMENDATION
We are maintaining our Speculative Buy rating and decreasing our target to
$2.25 from $2.50 to reflect the delay in the NDA filing. The primary near-term
drivers for our valuation continue to be the Company filing an NDA for CPI-300 with the FDA and negotiating an Alliance agreement for marketing the drug.
IGXT.OB..The next VNDA !!!!
This stock is vertualy unknown to investors. If you do your homework, you will clearly see that this stock will rise rapidly as soon as it gets noticed.
This is a real sleeper !!!! Please do your own Research .
Intelgenx Technologies (IGXT.OB)
MarketCap : 10,3 Mio US$
Price : 0,51 $
Shares Out : 20,85 M
Check out their fantastic Pipeline !
http://www.intelgenx.com/products/pipeline.html
Insider activity
http://finance.yahoo.com/q/it?s=IGXT.OB
RECENT OPERATIONAL HIGHLIGHTS ( May 2009)
- Filed NDA with U.S. Food and Drug Administration (FDA) - IntelGenx and Cary Pharmaceuticals filed a New Drug Application (NDA) under CFR 21 section 505(b)(2) for the CPI-300 antidepressant. CPI-300 is a new strength of a leading antidepressant that will provide a more convenient dosing option to patients with major depressive disorder ("MDD").
IntelGenx and Cary Pharmaceuticals 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 acted as the applicant for the submission of the NDA. Upon commercialization of the product, IntelGenx and Cary Pharmaceuticals would share profits.
- Earned Royalty Revenue for the first time in Company's History - IntelGenx earned royalty revenues of approximately $42.9 thousand in Q1, 2009 in respect of commercial activities in November and December 2008. Royalty revenues were earned from commercialization of the first product fully-developed by the Company, a prenatal multivitamin supplement marketed as Gesticare® in the USA, which was commercialized in November 2008.
- Announced Positive Phase 1(b) Clinical Study Results for Relivar - IntelGenx and Cannasat Therapeutics Inc., announced positive results for the Phase 1(b) clinical trial of Relivar, the first buccal dronabinol drug delivery product, which was developed using IntelGenx' proprietary AdVersa buccal delivery technology. Buccal delivery allows for drug absorption from the mouth directly into the bloodstream as opposed to the intestinal tract absorption seen with oral tablet technologies.
In this clinical trial, Relivar delivered twice the amount of dronabinol into the bloodstream versus the reference drug Marinol (as measured by AUC) with no increase in adverse events.
- Signed New Partnership Agreement with European Pharmaceutical Company - IntelGenx announced a new partnership with Circ Pharma Limited, a specialty pharmaceutical company based in Ireland, to develop and commercialize a novel drug for the treatment of hyperlipidemia.
In accordance with the Agreement, IntelGenx will be responsible for the formulation, manufacture and supply to Circ Pharma of the drug product. Circ Pharma will be responsible for commercialization of the product. Circ Pharma will fund the development of the product and IntelGenx will receive royalties from the product's sales.
In announcing the results, Horst Zerbe, President and Chief Executive Officer of IntelGenx, said:
"In the first few months of 2009 IntelGenx has already achieved a number of notable firsts in our corporate history: the 505(b)(2) NDA for the CPI-300 antidepressant was filed, and, for the first time, we earned sales and manufacturing royalties on the first
IGXT = Gift of the Year !
This stock is vertualy unknown to investors. If you do your homework, you will clearly see that this stock will rise rapidly as soon as it gets noticed.
This is a real sleeper !!!! Please do your own Research .
Intelgenx Technologies (IGXT.OB)
MarketCap : 10,3 Mio US$
Price : 0,51 $
Shares Out : 20,85 M
Check out their fantastic Pipeline !
http://www.intelgenx.com/products/pipeline.html
Insider activity
http://finance.yahoo.com/q/it?s=IGXT.OB
RECENT OPERATIONAL HIGHLIGHTS ( May 2009)
- Filed NDA with U.S. Food and Drug Administration (FDA) - IntelGenx and Cary Pharmaceuticals filed a New Drug Application (NDA) under CFR 21 section 505(b)(2) for the CPI-300 antidepressant. CPI-300 is a new strength of a leading antidepressant that will provide a more convenient dosing option to patients with major depressive disorder ("MDD").
IntelGenx and Cary Pharmaceuticals 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 acted as the applicant for the submission of the NDA. Upon commercialization of the product, IntelGenx and Cary Pharmaceuticals would share profits.
- Earned Royalty Revenue for the first time in Company's History - IntelGenx earned royalty revenues of approximately $42.9 thousand in Q1, 2009 in respect of commercial activities in November and December 2008. Royalty revenues were earned from commercialization of the first product fully-developed by the Company, a prenatal multivitamin supplement marketed as Gesticare® in the USA, which was commercialized in November 2008.
- Announced Positive Phase 1(b) Clinical Study Results for Relivar - IntelGenx and Cannasat Therapeutics Inc., announced positive results for the Phase 1(b) clinical trial of Relivar, the first buccal dronabinol drug delivery product, which was developed using IntelGenx' proprietary AdVersa buccal delivery technology. Buccal delivery allows for drug absorption from the mouth directly into the bloodstream as opposed to the intestinal tract absorption seen with oral tablet technologies.
In this clinical trial, Relivar delivered twice the amount of dronabinol into the bloodstream versus the reference drug Marinol (as measured by AUC) with no increase in adverse events.
- Signed New Partnership Agreement with European Pharmaceutical Company - IntelGenx announced a new partnership with Circ Pharma Limited, a specialty pharmaceutical company based in Ireland, to develop and commercialize a novel drug for the treatment of hyperlipidemia.
In accordance with the Agreement, IntelGenx will be responsible for the formulation, manufacture and supply to Circ Pharma of the drug product. Circ Pharma will be responsible for commercialization of the product. Circ Pharma will fund the development of the product and IntelGenx will receive royalties from the product's sales.
In announcing the results, Horst Zerbe, President and Chief Executive Officer of IntelGenx, said:
"In the first few months of 2009 IntelGenx has already achieved a number of notable firsts in our corporate history: the 505(b)(2) NDA for the CPI-300 antidepressant was filed, and, for the first time, we earned sales and manufacturing royalties on the first product fully-developed by the Company.
PDUFA Date 15 July .MCap 21 M$= Big Bounce
Rally already begins ..Target 3$ soon !!!!!!!!
Approval will be huge for ARDM.OB .Big bounce is coming
ARDM.OB
Marketcap 21 Mio $
Cash 19,8 Mio $
Price 0,14 $
The FDA accepted this resubmission as a complete response, providing the new Prescription Drug User Fee Act (PDUFA) review date of July 15, 2009.
In August 2006, we sold all of our assets related to the Intraject needle-free injector technology platform and products, including 12 United States patents along with foreign counterparts, to Zogenix, Inc., a private company. Zogenix is responsible for further development and commercialization efforts of Intraject (now rebranded under the name DoseProtm). We received a $4.0 million initial payment from Zogenix, and we will be entitled to a milestone payment upon initial commercialization, and royalty payments upon any commercialization of products in the U.S. and other countries, including the European Union, that may be developed and sold using the DosePro technology. In December 2007, Zogenix submitted a New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") for the migraine drug sumatriptan using the needle-free injector DosePro ("Sumaveltm DosePro"). The NDA was accepted for filing by the FDA in March 2008. The same month, Zogenix entered into a license agreement to grant exclusive rights in the European Union to Desitin Pharmaceuticals, GmbH to develop and commercialize Sumavel DosePro in the European Union. On October 31, 2008, Zogenix received a Complete Response Letter from the FDA on its NDA. On February 18, 2009, Zogenix disclosed that the Complete Response letter from the FDA cited the need for a single additional in vitro test to be conducted and that Zogenix recently submitted the requested information to the FDA. The FDA accepted this resubmission as a complete response, providing the new Prescription Drug User Fee Act (PDUFA) review date of July 15, 2009. Zogenix stated that it is their intention to launch Sumavel DosePro following FDA approval in the second half of 2009.
We recommend investors to take advantage of the current price weakness to purchase ARDM. At a market cap of $11 million and $22 million in cash as of February 2009, we do not believe the value for Aradigm’s pipeline including ILC or the inhaled Remodulin partnership is at all reflected in the current valuation. We strongly reiterate our BUY rating. The reduction of our price target to $3.30 from $6.00 is largely a function of the significant increase in the number of shares outstanding to 95 million from 54 million as a result of the recent 40 million share financing which was priced at $0.10 per share. Our price target is based on a 25x multiple of our 2012 fully-diluted EPS of $0.28 discounted back at 35% (see Table 2 below for details).
Time to buy !!!!!!!!!!!!
Psivida (PSDV)
MarketCap : 32,8 M$
Cash : 8,02 M$
Price : 1,80$
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.
For the quarter ended March 31, 2009, the Company reported a consolidated net loss of $636,000, or $0.03 per share, compared to a consolidated net loss of $5.5 million, or $0.30 per share, for the quarter ended March 31, 2008. Revenues for the three months ended March 31, 2009 were $3.2 million compared to revenues of $542,000 for the three months ended March 31, 2008. Cash and cash equivalents totaled $8.0 million at March 31, 2009.
Big news coming soon !!!
Cytosorbents will have a presentation at the In3East Conference.
CytoSorbents also announced it will present at the upcoming In3 East medical device conference at the Westin Copley Place Hotel in Boston, MA on Wednesday, June 24, 2009, hosted by Medtech Insight and Windhover Information Inc. Dr. Chan is scheduled to present at 2:10PM EDT. The In3 conference is the largest East Coast strategic partnership and investment conference for medical device companies. MedTech Insight and Windhover, also known as Elsevier Business Intelligence, are subsidiaries of Elsevier, the world's leading publisher of science, technical and health information.
PSDV..Significantly Undervalued
This stock is vertualy unknown to investors. If you do your homework, you will clearly see that this stock will rise rapidly as soon as it gets noticed.
Pfizer is biggest Shareholder (1,9 million shares)
Psividia (PSDV)
MarketCap : 32,8 M$
Cash : 8,02 M$
Price : 1,80$
Shares Out : 18,26 M
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.
For the quarter ended March 31, 2009, the Company reported a consolidated net loss of $636,000, or $0.03 per share, compared to a consolidated net loss of $5.5 million, or $0.30 per share, for the quarter ended March 31, 2008. Revenues for the three months ended March 31, 2009 were $3.2 million compared to revenues of $542,000 for the three months ended March 31, 2008. Cash and cash equivalents totaled $8.0 million at March 31, 2009.
A lifetime Chance ..Please do your own Research
Medasorb ( MSBT.OB )
MarketCap : 1,8 Mio US$
Cash : 2,9 Mio US$
Price 0,06 $
Shares Out : 30,5 million ( 59% held by Insider´s)
CytoSorbents, Inc. Recognized as "Company Most Likely to Succeed" at the 2009 New Jersey Venture Conference and Provides Clinical Update
MONMOUTH JUNCTION, NJ--(MARKET WIRE)--Mar 30, 2009 -- CytoSorbents, Inc., the wholly-owned operating subsidiary of MedaSorb Technologies Corporation (OTC BB:MSBT.OB - News), announced it was chosen as "Company Most Likely to Succeed" by independent judges at the 2009 New Jersey Technology Council Venture Conference on March 27, 2009. The Company was one of 60 healthcare and technology companies presenting at the conference who were eligible for this coveted all-around award. "We feel extremely honored to have received this award, particularly against such solid competition," stated Dr. Phillip Chan, CEO. "It is especially gratifying that others recognize the significant value we are building and the potential of our technology to treat severe sepsis, one of the top medical causes of death in the world. We are committed to increasing shareholder value by making significant progress on key milestones and objectives, including our European Sepsis Trial. Among other means, we will continue to foster increased awareness of our Company through venues such as the New Jersey Technology Council Venture Conference and the In3 West Conference that we presented at in early March. Our story has been getting stronger and has been well-received because it is based on compelling science and our unique CytoSorb(TM) blood purification technology."
CytoSorbents provides the following clinical update on its current European Sepsis Trial:
-- Twenty-two patients have been enrolled to date from three trial sites.
-- Recruitment is now expected to accelerate with a current total of ten
initiated clinical sites.
-- The CytoSorb(TM) treatment has been well-tolerated by patients and
easily administered by hospital staff on standard dialysis equipment.
-- There have been no serious device related adverse events associated
with CytoSorb(TM) treatment in more than 450 human treatments,
approximately 90 of which have been in septic patients.
-- The Company continues to expect trial completion in 2009 with the goal
of CE Mark approval and initial commercial sales in Europe next year.
--------------------------------------
RedChip Visibility Initiates Research On MedaSorb Technologies
2006-08-22 13:49 ET - News Release
ORLANDO, Fla., Aug. 22, 2006 (PRIMEZONE) -- RedChip Visibility, a division of RedChip Companies, announced today that they have initiated research on MedaSorb Technologies (OTCBB:MSBT).
Patrick Murphy, CFA, RedChip Research Analyst, wrote in the report:
"We believe it is reasonable to expect that MedaSorb will get its products to market in the time frame projected by management, and that the upside potential is more than sufficient to justify the many risks associated with an investment today. Assuming CytoSorbT (MedaSorb's primary product which is used in the treatment of the symptoms associated with sepsis, cardiopulmonary bypass surgery, organ donation transplantation, and drug overdoses.) makes it to market in 3 years, MedaSorb will be
worth at least $375 million, 3 years from now."
re MSBT.OB ..Any thoughts on this?
No comments ?
CytoSorbents, Inc to Present at the BIO International Convention and the In3 East Conference
* On Friday May 15, 2009, 9:15 am EDT
* MedaSorb Technologies Corporation
MONMOUTH JUNCTION, NJ--(MARKET WIRE)--May 15, 2009 -- CytoSorbents, Inc, and its parent MedaSorb Technologies Corporation (OTC BB:MSBT.OB - News), a clinical trial stage medical device company evaluating CytoSorb(TM) -- a novel blood purification device for the treatment of severe sepsis, announced that Phillip Chan, MD, PhD, Chief Executive Officer, will present at the BIO International Convention at the Georgia World Congress Center in Atlanta, GA on Tuesday, May 19, 2009. CytoSorbents' presentation is scheduled to begin at 4PM EDT in Room 314. CytoSorbents was one of a select group of companies chosen to make a presentation. The Biotechnology Industry Organization (BIO) represents more than 1,200 biotechnology companies and related organizations from the United States and more than 30 other countries. The conference is the largest biotechnology event in the world, attracting in excess of 20,000 attendees each year from 68 countries.
CytoSorbents also announced it will present at the upcoming In3 East medical device conference at the Westin Copley Place Hotel in Boston, MA on Wednesday, June 24, 2009, hosted by Medtech Insight and Windhover Information Inc. Dr. Chan is scheduled to present at 2:10PM EDT. The In3 conference is the largest East Coast strategic partnership and investment conference for medical device companies. MedTech Insight and Windhover, also known as Elsevier Business Intelligence, are subsidiaries of Elsevier, the world's leading publisher of science, technical and health information. (http://www.windhover.com/mti/template.asp?page=in3_east09&eventID=16)
Copies of the presentations and an investor package are available upon request.
About CytoSorbents and CytoSorb(TM)
CytoSorbents, Inc, with its parent MedaSorb Technologies Corporation, is in clinical trials to treat severe sepsis, often called "overwhelming infection", with a novel blood purification device called CytoSorb(TM). Severe sepsis is typically caused by bacterial infections like pneumonia, or viral infections like influenza (including virulent avian and swine influenza strains). It afflicts an estimated 18 million people worldwide each year. In countries practicing modern medicine, it still kills one in every three, making it a leading medical cause of death despite the best treatment. In the U.S., more die from severe sepsis than from either heart attacks, strokes or any single form of cancer. Much of the organ failure and mortality in severe sepsis is caused by the abnormal massive production of cytokines by the immune system, often called "cytokine storm." CytoSorb(TM) is a patented highly porous polymer resin that acts as a cytokine filter and was designed to reduce potentially fatal cytokine storm. As blood is pumped through a cartridge of these blood compatible beads using standard dialysis equipment, cytokines and other toxins are captured by the beads and removed from blood. The treated blood is then returned to the patient. The Company is currently conducting its European Sepsis Trial -- a multi-center, randomized, controlled clinical trial using its flagship CytoSorb(TM) device to treat up to 100 patients with severe sepsis in the setting of respiratory failure. CytoSorb(TM) is one of a number of different resins designed for different medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, treatment of rhabdomyolysis in trauma, drug detoxification and others.
MSBT.OB ..Any thoughts on this?
Looks very interesting
Medasorb ( MSBT.OB )
MarketCap : 1,8 Mio US$
Cash : 2,9 Mio US$
Price 0,06 $
CytoSorbents, Inc. Recognized as "Company Most Likely to Succeed" at the 2009 New Jersey Venture Conference and Provides Clinical Update
http://finance.yahoo.com/news/CytoSorbents-Inc-Recognized-iw-14784558.html
-- Twenty-two patients have been enrolled to date from three trial sites.
-- Recruitment is now expected to accelerate with a current total of ten
initiated clinical sites.
-- The CytoSorb(TM) treatment has been well-tolerated by patients and
easily administered by hospital staff on standard dialysis equipment.
-- There have been no serious device related adverse events associated
with CytoSorb(TM) treatment in more than 450 human treatments,
approximately 90 of which have been in septic patients.
-- The Company continues to expect trial completion in 2009 with the goal
of CE Mark approval and initial commercial sales in Europe next year.
MONMOUTH JUNCTION, NJ--(MARKET WIRE)--Mar 30, 2009 -- CytoSorbents, Inc., the wholly-owned operating subsidiary of MedaSorb Technologies Corporation (OTC BB:MSBT.OB - News), announced it was chosen as "Company Most Likely to Succeed" by independent judges at the 2009 New Jersey Technology Council Venture Conference on March 27, 2009. The Company was one of 60 healthcare and technology companies presenting at the conference who were eligible for this coveted all-around award. "We feel extremely honored to have received this award, particularly against such solid competition," stated Dr. Phillip Chan, CEO. "It is especially gratifying that others recognize the significant value we are building and the potential of our technology to treat severe sepsis, one of the top medical causes of death in the world. We are committed to increasing shareholder value by making significant progress on key milestones and objectives, including our European Sepsis Trial. Among other means, we will continue to foster increased awareness of our Company through venues such as the New Jersey Technology Council Venture Conference and the In3 West Conference that we presented at in early March. Our story has been getting stronger and has been well-received because it is based on compelling science and our unique CytoSorb(TM) blood purification technology."
CytoSorbents provides the following clinical update on its current European Sepsis Trial:
re:synthetic heparin ANDA accepted by FDA
Great news eom
Alchemia - Fondaparinux ANDA accepted by FDA for Review Mon, 11 May 2009 10:13:00 +1000
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.
This Undiscovered Stock is ready to explode
Please read this great Article
http://seekingalpha.com/article/136044-access-pharma-low-valuation-big-potential?source=yahoo
Access Pharma (ACCP.OB)
Marketcap : 33 Mio US$
Price : 1,50 US$
350 Million US$ Potential for MuGard
Access Pharmaceuticals Announces the European Launch of MuGard(TM) by its European Partner, SpePharm
* On Wednesday April 22, 2009, 9:00 am EDT
DALLAS, April 22 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP - News), announced today that MuGard(TM), its proprietary polymer-based oral mucositis product has been launched in Germany, Italy, UK, Greece and the Nordic countries by its European commercial partner, SpePharm, a pan-European specialty pharmaceutical company dedicated to the provision of high medical value medicines in supportive and critical care.
Under a license from Access Pharmaceuticals Inc, SpePharm is responsible for manufacturing, regulatory approval and commercialization in the 27 countries of Europe. In October 2008, MuGard was granted CE Mark certification by the Dutch Notified Body (KEMA). SpePharm plans to launch MuGard in the rest of Europe over the coming 12 to 18 months. Access will receive significant royalties on net sales.
"SpePharm and Access are pleased with the commercial launch of MuGard in Europe, and while it is still in the early days, initial feedback has been positive," said Phillip Wise, Vice President of Business Development at Access. "SpePharm is also working hard to secure reimbursement from the individual governmental regulators, which we believe will greatly enhance initial product adoption and ongoing marketing efforts to reach and penetrate the target population of patients requiring this important treatment option. We look forward to further commercial launches from our other MuGard commercialization partners," he continued.
MuGard is a ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or radiotherapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.
MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.
Nuvo Research Inc. (TSX: NRI), a Canadian drug development company focused on the research and development of drug products that are delivered to and through the skin using its topical and transdermal drug delivery technologies, today announced its financial and operational results for the quarter ended March 31, 2009.
<<
Recent Corporate Developments:
- Successfully completed all Pennsaid(R) studies necessary to resubmit
the application for Pennsaid approval to the United States Food and
Drug Administration (FDA). The FDA confirmed that it has accepted
this filing as a complete response to its Approvable Letter for
Pennsaid dated December 28, 2006 and pursuant to the Prescription
Drug User Fee Act provided the Company with a date of August 5, 2009
(the PDUFA Date) by which the FDA intends to advise Nuvo on
Pennsaid's approvability
- Received net proceeds of $3.7 million from the exercise of warrants
under the warrant incentive program
- Was awarded the bronze medal in the Science and Medical category of
the 2009 Edison Awards for the Company's High Throughput
Experimentation platform
- Was advised that PAIN(R) , the world's leading publication on pain
research and treatments and the official journal of the International
Association for the Study of Pain will be publishing an article
outlining the successful results of the Company's 112 efficacy trial
in its June 2009 issue
>>
"With our PDUFA Date rapidly approaching, we remain highly optimistic about Pennsaid's potential for approval and are continuing discussions with potential United States licensing partners," said Henrich Guntermann, President and Chief Executive Officer of Nuvo Research.
Parkinson disease Positive PIII data ...
Newron Pharma (NRWN.SW) Listed on Swiss Exchange
MarketCap : 99,97 Mio CHF ( 88,26 Mio US$ )
Cash : 62,38 Mio CHF ( 55,07 Mio US$ )
Price : 16,5 CHF
Shares Out : 6,03 Mio
Pipeline
http://www.newron.com/uploads/pipeline_111November3.pdf
Safinamide Significantly Improved Motor Function in Patients with Advanced
Parkinson’s Disease in a Phase III Pivotal Trial
http://www.newron.com/uploads/SAfinamidePIIIresultsNewronENG3Feb.pdf
Homepage
http://www.newron.com/default.asp
By Julia Mengewein 11.03.2009
Of DOW JONES NEWSWIRES
ZURICH -(Dow Jones)- The ongoing late-stage trial for Newron Pharmaceuticals SpA's (NWRN.EB) back-pain drug candidate ralfinamide is going ahead as planned, Chief Financial Officer Stefan Weber told Dow Jones in an interview Wednesday.
"The trial is going according to plan," Weber said.
News from this study will be pivotal for outlicensing ralfinamide, which could be the first treatment for neuropathic lower back pain, analysts say. Newron plans to release full data of the trial early in 2010, but may strike a deal before then.
"Then (early in 2010) at the latest, we will outlicense the drug," Weber said. He added that talks with potential partners are already ongoing, but declined to elaborate further.
Intermediate data so far has shown that the drug is reducing pain for patients and increasing their quality of life and sleep.
Analysts see sales potential of up to $1.5 billion for ralfinamide in its best years, with market entry expected for around 2012.
Newron, based in Milan, Italy, but listed in Switzerland, will need another late-stage trial of ralfinamide for market approval.
"We want to carry out the second study with a partner," Weber said.
Those companies which specialize in pain should be interested in ralfinamide, analysts say. Among the companies proficient in this area are Pfizer Inc. (PFE), GlaxoSmithKline PLC. (GSK) and also AstraZeneca PLC. (AZN.LN).
Hep C Phase 1b/2a results soon
Biotron (BIT.AX)
MarketCap: 11,4 MioA$ ( 8,3 MioUS$)
Price : 0,09 A$
Your support of your Company at this time is critical to:
Completion of the Phase Ib/IIa Hepatitis C virus ('HCV') clinical trial.
Ensuring that commercialisation negotiations following the completion of the HCV clinical trial are
undertaken with the Company in a position of financial security.
The Directors encourage all eligible shareholders to support the Company and take advantage of this
opportunity to acquire Biotron shares without brokerage or other transaction costs and at a discount of
approximately 15% to the weighted average share price for the five business days preceding the date that the
SPP was announced.
Introduction
Biotron has achieved great success in its antiviral drug development program to date, culminating in its lead
investigation drug, BIT225, currently being trialed in HCV positive patients.
This human trial will provide the first evidence of the efficacy (the antiviral effectiveness) of BIT225 in HCV
positive patients. The successful completion of this human trial will represent the most significant milestone
achievement for the Company to date and is the result of many years of painstaking work.
The vast majority of potential drugs never reach this stage of development and the significance of BIT225
reaching this stage of development and the work completed to get BIT225 to this stage should not be
underestimated.
Following a successful completion of this human trial, the Company will focus its efforts on completing a
commercial deal with a pharmaceutical company to continue the development of BIT225 to a marketable drug.
Discussions with a number of pharmaceutical companies have been ongoing for some time and BIT225 is well
known in the drug development industry. The Directors are keen to ensure that completion of commercial deal
is not hurried or compromised by the Company's short term financial constraints. The success of a commercial
deal will be assisted by the support of shareholders at this critical time.
History
In late 2007, the Company completed a successful Phase I, first-in-human study of BIT225 in healthy
volunteers.
Following this success, the first half of 2008 was spent designing the Phase Ib/IIa trial of BIT225 in patients
infected with HCV – the first study of the drug in a patient population.
2
In consultation with experts in the field, the trial design was finalised, and documentation prepared for obligatory
ethics and regulatory submissions. Approval for commencement of the Phase Ib/IIa trial was given in August
2008. The trial, code-named BIT225-003, is a placebo-controlled, randomised study of the safety,
pharmacokinetics and antiviral activity of BIT225 in patients with HCV infection designed to assess the safety
and tolerability of BIT225, to assess the pharmacokinetics of BIT225 and to assess the antiviral efficacy of
BIT225 in these patients.
Eighteen patients are being randomly assigned to receive one of two dose levels of BIT225 or placebo. The
trial is being conducted at two trial sites, based in Sydney and Brisbane, to expedite the trial by maximising the
eligible patient recruitment rate.
Patient recruitment was initially slower than expected, however, modifications to the trial which have been made
with ethics and regulatory approvals have resulted in a significant improvement in patient recruitment rates. To
date, a total of 6 patients have successfully completed the trial and a further 6 patients are currently in a pre-trial
process and are expected to be dosed within the next two weeks, subject to passing the pre-trial eligibility
criteria.
Patient recruitment for the trial is expected to be completed by the end of March 2009.
Due to the design of the trial, results are not available until the end of the study. The trial is blinded, with
patients receiving one of two dose levels of BIT225 or placebo and the study will only be unblinded at the
conclusion of the trial.
While data from the patients dosed to date is incomplete and unknown to the Company, there have been no
reported serious adverse events and the trial continues. It is truly a case of 'no news is good news'.
Financial History
The Company has been strictly managed financially, having raised a total of only $19.1 million from
shareholders and only seeking shareholder support on three occasions since its initial public offering in
December 2000.
At the time of the last capital raising in late 2007, Biotron anticipated leveraging shareholder funds, as it had
done so before, by accessing matching funding for the Phase Ib/IIa trial through the Federal Government’s
Commercial Ready grant program. Regrettably and without any indication to do so, the Federal Government
cancelled the Commercial Ready grant program in the May 2008 Federal budget, right at the time that Biotron
was finalising protocols. Biotron had not anticipated having to fully fund the trial, so the cancellation of the grant
program has had a significant adverse impact on the financial position of the Company.
The cancellation of the Commercial Ready grant program caused the Company to hold the commencement of a
second Phase Ib/IIa clinical trial for the treatment of HIV and focus the Company's financial resources on the
HCV clinical trial. The HIV clinical trial, which has finalised protocols ready for submission for ethical and
regulatory approvals, could be commenced quickly with sufficient financial resources.
The Company is focused on achieving a successful outcome from the HCV trial, and has been progressing
discussions with potential pharmaceutical companies in anticipation of finalising a deal once the trial has been
completed. The trial has been designed to benefit shareholders through significantly increasing the value of
Biotron in the market and to its future pharmaceutical company partners.
It is critical that the Company be sufficiently funded to enable full analysis and review of the data, and to enable
negotiation of a partnership/licensing deal with an international pharmaceutical company at the conclusion of
the trial. To this end, the Directors believe it is prudent at this time to raise additional capital to ensure that
maximal value can be extracted from the trial for shareholder value creation. Being in a strong financial position
will put Biotron in a stronger negotiating position with potential partners. The Directors also believe it
appropriate to offer existing eligible shareholders the opportunity to participate in this exciting time of the
Company's development by way of the SPP.
Purpose of the Capital Raising
The funds raised by the SPP will be used to support the Company's ongoing operational costs, including
funding the completion of the Phase Ib/IIa HCV clinical trial and ensuring the Company is in a position to
complete negotiation of a licensing deal.
re best in class topical NSAID for osteo-arthritis
Pennsaid(R) Phase 3 study results to be published in leading international PAIN journal
4/23/2009 7:00 AM - Canada NewsWire
MISSISSAUGA, ON, Apr 23, 2009 (Canada NewsWire via COMTEX News Network) --
Nuvo Research Inc. (TSX: NRI), a Canadian drug development company focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies, today announced that study results demonstrating that the Company's lead product, Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), is an efficacious treatment for the symptoms of osteoarthritis of the knee will be published in the June 2009 edition of PAIN.
PAIN is the world's leading publication on pain research and treatments and the official journal of the International Association for the Study of Pain (IASP(R)). The IASP, founded in 1973, is the leading professional forum for science, practice, and education in the field of pain and has more than 6,500 members in 118 countries who are professionals involved in the research, diagnosis and treatment of pain.
The scientific article details Nuvo's previously announced study results, which demonstrated that Pennsaid is efficacious for the relief of symptoms in patients with knee osteoarthritis. In addition, the study demonstrated that Pennsaid is as effective as oral diclofenac at relieving knee osteoarthritis symptoms but with less NSAID-related systemic toxicity. The article, titled, "Efficacy and safety of topical diclofenac containing dimethyl sulfoxide (DMSO) compared with those of topical placebo, DMSO vehicle and oral diclofenac for knee osteoarthritis", was written by Dr. Lee Simon as lead author, and Dr. Lisa Grierson, Zahid Naseer, Dr. Arthur A.M. Bookman, M.D., and Dr. J. Zev Shainhouse as co-authors. It is currently available on the PAIN website.
"The publication of this article in the premier international pain journal further confirms Pennsaid's unique and compelling efficacy and safety profile among all other topical NSAIDs," said Dr. Brad Galer, Vice President and General Manager of Nuvo's Pain Group. "This published data provides further support to our conclusion that Pennsaid, when approved by the U.S. Food and Drug Administration (FDA), will be the best-in-class product available in the United States."
Nuvo resubmitted its application for Pennsaid approval to the FDA in February 2009. The FDA has indicated that it intends to advise Nuvo of its decision regarding the approval of Pennsaid by August 5, 2009 (the "PDUFA Date") under the Prescription Drug User Fee Act.
The subject of the PAIN article is Nuvo's Phase 3 trial, Study 112, which enrolled 775 patients in the U.S. and Canada with symptoms of primary osteoarthritis of the knee. Patients in this five-arm, double-blind, 12-week trial applied a topical solution and took an oral pill. The five arms were: 1) Pennsaid plus oral placebo, 2) topical placebo containing a small amount of DMSO for blinding purposes (DMSO facilitates delivery of diclofenac to the knee) plus oral placebo, 3) topical vehicle-control (containing the same concentration of DMSO as in Pennsaid) plus oral placebo, 4) topical placebo plus oral diclofenac and 5) Pennsaid plus oral diclofenac.
Pennsaid (arm 1) was superior to placebo (arm 2) with statistically significant improvement in all three primary clinical endpoints required by the FDA: pain relief (p=0.019), improvement in physical function (p=0.046) and improved patient overall health assessment (POHA) (p(less than)0.0001).
Additional results from the trial show that Pennsaid (arm 1) was superior to vehicle control (arm 3) (pain, p=0.009; physical function, p=0.026; POHA, p=0.016). There was no difference between vehicle control (arm 3) and placebo (arm 2) indicating that DMSO alone is ineffective against the symptoms of knee osteoarthritis (p greater than 0.05). There was no difference between Pennsaid (arm 1) and oral diclofenac (arm 4) for all three efficacy endpoints (p greater than 0.05). Arm 5 was included in the trial at the FDA's request to review the side effect profile of Pennsaid if combined with an oral NSAID. This combination showed no increased incidence of the usual systemic side effects, just the expected additive profiles of Pennsaid alone plus oral diclofenac alone.
Dry skin was the most common adverse event with Pennsaid use. Fewer digestive system adverse events and laboratory abnormalities (decreased hemoglobin and increased AST, ALT and creatinine) were observed with Pennsaid as compared to oral diclofenac.
re best in class topical NSAID for osteo-arthritis
Pennsaid(R) Phase 3 study results to be published in leading international PAIN journal
4/23/2009 7:00 AM - Canada NewsWire
MISSISSAUGA, ON, Apr 23, 2009 (Canada NewsWire via COMTEX News Network) --
Nuvo Research Inc. (TSX: NRI), a Canadian drug development company focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies, today announced that study results demonstrating that the Company's lead product, Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), is an efficacious treatment for the symptoms of osteoarthritis of the knee will be published in the June 2009 edition of PAIN.
PAIN is the world's leading publication on pain research and treatments and the official journal of the International Association for the Study of Pain (IASP(R)). The IASP, founded in 1973, is the leading professional forum for science, practice, and education in the field of pain and has more than 6,500 members in 118 countries who are professionals involved in the research, diagnosis and treatment of pain.
The scientific article details Nuvo's previously announced study results, which demonstrated that Pennsaid is efficacious for the relief of symptoms in patients with knee osteoarthritis. In addition, the study demonstrated that Pennsaid is as effective as oral diclofenac at relieving knee osteoarthritis symptoms but with less NSAID-related systemic toxicity. The article, titled, "Efficacy and safety of topical diclofenac containing dimethyl sulfoxide (DMSO) compared with those of topical placebo, DMSO vehicle and oral diclofenac for knee osteoarthritis", was written by Dr. Lee Simon as lead author, and Dr. Lisa Grierson, Zahid Naseer, Dr. Arthur A.M. Bookman, M.D., and Dr. J. Zev Shainhouse as co-authors. It is currently available on the PAIN website.
"The publication of this article in the premier international pain journal further confirms Pennsaid's unique and compelling efficacy and safety profile among all other topical NSAIDs," said Dr. Brad Galer, Vice President and General Manager of Nuvo's Pain Group. "This published data provides further support to our conclusion that Pennsaid, when approved by the U.S. Food and Drug Administration (FDA), will be the best-in-class product available in the United States."
Nuvo resubmitted its application for Pennsaid approval to the FDA in February 2009. The FDA has indicated that it intends to advise Nuvo of its decision regarding the approval of Pennsaid by August 5, 2009 (the "PDUFA Date") under the Prescription Drug User Fee Act.
The subject of the PAIN article is Nuvo's Phase 3 trial, Study 112, which enrolled 775 patients in the U.S. and Canada with symptoms of primary osteoarthritis of the knee. Patients in this five-arm, double-blind, 12-week trial applied a topical solution and took an oral pill. The five arms were: 1) Pennsaid plus oral placebo, 2) topical placebo containing a small amount of DMSO for blinding purposes (DMSO facilitates delivery of diclofenac to the knee) plus oral placebo, 3) topical vehicle-control (containing the same concentration of DMSO as in Pennsaid) plus oral placebo, 4) topical placebo plus oral diclofenac and 5) Pennsaid plus oral diclofenac.
Pennsaid (arm 1) was superior to placebo (arm 2) with statistically significant improvement in all three primary clinical endpoints required by the FDA: pain relief (p=0.019), improvement in physical function (p=0.046) and improved patient overall health assessment (POHA) (p(less than)0.0001).
Additional results from the trial show that Pennsaid (arm 1) was superior to vehicle control (arm 3) (pain, p=0.009; physical function, p=0.026; POHA, p=0.016). There was no difference between vehicle control (arm 3) and placebo (arm 2) indicating that DMSO alone is ineffective against the symptoms of knee osteoarthritis (p greater than 0.05). There was no difference between Pennsaid (arm 1) and oral diclofenac (arm 4) for all three efficacy endpoints (p greater than 0.05). Arm 5 was included in the trial at the FDA's request to review the side effect profile of Pennsaid if combined with an oral NSAID. This combination showed no increased incidence of the usual systemic side effects, just the expected additive profiles of Pennsaid alone plus oral diclofenac alone.
Dry skin was the most common adverse event with Pennsaid use. Fewer digestive system adverse events and laboratory abnormalities (decreased hemoglobin and increased AST, ALT and creatinine) were observed with Pennsaid as compared to oral diclofenac.
re Very attractive Company from France
http://www.bioalliancepharma.com/eng/Press-room/Communiques-de-presse2/Press-releases
21/04/2009
BioAlliance Pharma presents results on its new oral Irinotecan nanoparticle formulation for the treatment of advanced colorectal cancer at the American Association for Cancer Research (AACR) 100th Annual Meeting in Denver, April 18 to 22, 2009 (PDF - 86 Ko)
21/04/2009
BioAlliance Pharma presents results on its new biotherapy plasmid AMEP™ for metastatic melanoma at the American Association for Cancer Research (AACR) 100th Annual Meeting in Denver, April 18 to 22, 2009 (PDF - 89 Ko)
Very attractive Company from France
This stock is Significantly Undervalued ...Please do your own Research .
BioAlliance Pharma ( BIO.PA ) << France Stock
MarketCap : 30,3 Mio €....( 41,4 M$ )
Cash : 32 Mio €... ( 43,4 M$ )
Price: 2,30 €
Shares Out : 12,9 million
Pipeline
http://www.bioalliancepharma.com/eng/R-D/Projects
Presentation March 2009 << Please read
http://www.bioalliancepharma.com/eng/content/download/3173/33942/version/1/file/090506EN_SFAF%20annual%20results%202008.pdf
Cash and cash equivalents as of December 31 2008 amounted to €31.7 million. Furthermore, and setting aside any new agreements signed in the coming years, BioAlliance Pharma expects to receive up to $21.5 million in milestone payments in 2009-2010 under the terms of its existing licensing and collaboration agreements. The company is also expecting to receive €4 million as a research tax credit.
Comments on the group's business activity in the first quarter of 2009, and outlook
On February 27, 2009, BioAlliance Pharma reacquired the sales rights to Loramyc® in Europe and terminated the exclusive license contract signed in 2007 with the company SpeBio. In order to obtain compensation for losses suffered as a result of delays in commercialization and sale of Loramyc®, BioAlliance Pharma has initiated legal proceedings against SpeBio at the Paris trade tribunal.
Despite the pharmaceutical market slow-down and a turbulent macro-economic situation, BioAlliance Pharma is confident of its ability to ensure the continued Europe-wide commercialization of Loramyc® directly via its own sales teams in some countries and through specialist oncology partners in others.
Furthermore, in March, BioAlliance Pharma was awarded marketing approval for Loramyc® in South Korea and has now initiated pricing and reimbursement procedures with its partner, Handok.
The next key steps in BioAlliance Pharma's development are as follows:
acceptance of US filing for Loramyc® in the United States: Q2 2009.
a new European sales organization for Loramyc®: 2009.
completion of the first Phase III trial of acyclovir Lauriad in Europe: H2 2009.
integration of an advanced project (nursing): Q2 2009.
new alliances in 2009.
approval of Loramyc® by the FDA: Q1 2010.
the European launch of ondansetron RapidFilm™: H1 2010.
Filing for registration of ondansetron Oral Spray: H1 2010.
Commenting on BioAlliance Pharma's 2008 performance, Dominique Costantini (the company's President and CEO) declared: "At the end of the full first year of Loramyc® sales in France, we can see that our first marketed product is integrating well into prescribing habits and expert recommendations. Loramyc® has been administered to nearly 20,000 patients and consolidated sales have reached the symbolic €1 million threshold. We are going to build on this success in 2009. Internationally, we signed two new license agreements on Loramyc® in south-east Asia and prospects for the North American market are looking good, following this year's positive results in our Phase III study".
Dominique Costantini added, "In 2008, we sought to maximize the potential for value creation. This meant that in order to optimize our commercial organization, we licensed-in two complementary cancer supportive care products for Europe. The two products are close to registration and will generate commercial synergies in the near future. Lastly, we have refocused our resources on the most promising R&D projects by capitalizing on our unique technological know-how. Today, BioAlliance Pharma is in good shape to tackle the challenges of 2009 and pursue its balanced growth track".
re synthetic heparin << ANDA filing
on the move ....
http://finance.yahoo.com/q/bc?s=ACL.AX&t=5d&l=on&z=m&q=l&c=
17-Mar-2009
Investor Presentation
http://www.alchemia.com.au/IRM/Company/ShowPage.aspx?CPID=1387&PageName=Investor%20Presentation
Summary
ANDA submitted to US FDA for fondaparinux
Launch anticipated in H2 2009
Significant revenue opportunity
Preparing for pivotal Phase III trial of HA-irinotecan
Opportunity to commence metastatic colorectal cancer trial in 2009
Multiple opportunities for HyACT technology
Supergenerics
Lifecycle management
Antibodies
24months cash, sufficient to reach fondaparinux revenues
synthetic heparin << ANDA filing
Fantastic news
Alchemia Limited( ACL.AX )
Marketcap : 25 million A$
Cash : 11 million A$
Price : 0,22 A$
Sydney - Friday - March 13: (RWE Australian Business News) -
Alchemia Ltd (ASX:ACL) today announced its global manufacturing and US
marketing partner, NYSE-listed Dr Reddy's Laboratories, had submitted an
Abbreviated New Drug Application (ANDA) with the United States Food and
Drug Administration (FDA) for Fondaparinux Sodium for Injection in
2.5mg, 5.0mg, 7.5mg and 10.0mg doses.
The application has been filed with a Paragraph II certification
indicating that there is no remaining patent listed for the drug.
Fondaparinux is marketed by GlaxoSmithKline under the brand name
Arixtra. It is an anticoagulant currently approved for a number of
indications including the treatment and prevention of deep vein
thrombosis (blood clots) in a number of medical settings such as
post-operative knee and hip surgery.
In 2008, global sales of Arixtra were $US315m (+58pc) and sales
in the US market were $US163m (+50pc).
"The filing of the ANDA is a major achievement for Alchemia. Of
all the drugs used in modern medicine, fondaparinux is one of the most
challenging molecules to synthesise, and we are proud to have
accomplished this feat with Dr Reddy's, our partner for its
manufacturing and commercialisation," said Dr Pete Smith, chief
executive of Alchemia.
"Whilst the key patents on Arixtra expired in 2002, no company
has filed for the approval of its generic until now, and we are not
aware of any other generic manufacturers currently capable of making
this molecule at commercial scale.
"Because we do not foresee the entry of other competitors in the
near term, we expect pricing, market share and profitability to remain
higher compared to a typical generic product."
re : AGY gigantic Potential
Allergy Therapeutics Pollinex Quattro Phase III trial meets efficacy goal UPDATE
LONDON (Thomson Financial) - Allergy Therapeutics plc (LSE: AGY.L - news) ADVERTISEMENT
, the specialist pharmaceutical company focused on allergy vaccination, today announces positive results from its Pollinex Quattro Grass Phase III study, G301, the largest controlled allergy vaccine study ever conducted, it said.
The result clears the way for the company to apply for marketing approval in the European Union, with the submission planned for the first quarter of next year.
The company currently has development in the US on hold while the FDA has a clinical stay in place.
Keith Carter, chief executive officer of Allergy Therapeutics, said this is the most important piece of news in the 70-year history of the company.
He told Thomson Financial News in a telephone interview: 'We've invested very hard, this is why we went public to fund these trials and it's really great to be able to announce that it's all been worthwhile. Clearly this is a huge step forward not just for us but for allergen vaccination generally and for patients who suffer from allergies.'
He added that the trial also showed that Pollinex Quattro had a good safety profile and patients complied well with the dosing requirement.
Marketing director Kevin Wilkinson estimated that the market in Europe for allergy vaccines was about 500 million euro.
The announcement is expected to boost current sales of Pollinex Quattro, which are on a named-patient basis, as well as boost future sales after registration.
Carter explained that the announcement would help the company in licensing talks. 'We would like to partner to accelerate the introduction of the product across Europe and these results will allow us to have very meaningful conversations with partners,' he said.
Nomura Code Securities, in a note to clients, said it viewed the results as 'highly encouraging'.
'We view these results as highly encouraging for out-licensing prospects and EU approval. We continue to believe that the FDA clinical hold will be lifted and reiterate our 'Buy' recommendation with a price target of 118p, based only on approval and sales in the EU.'
AGY.L << Great News
Allergy Therapeutics (AGY.L)
MarketCap .. 6 million GBP << 8,7 million US$
Price.. 7p
http://finance.yahoo.com/q?s=agy.l&x=62&y=20
Allergy Therapeutics plc
("Allergy Therapeutics" or "the Company")
Pollinex® Quattro Grass Dossier Submitted for European Union ('EU') Regulatory Review
Allergy Therapeutics (AGY), the specialist pharmaceutical company focused on allergy vaccination, announces that it has submitted its Pollinex Quattro Grass dossier for regulatory approval in the EU.
The dossier has been submitted to the German Regulatory authority, the Paul Ehrlich Insitut ("PEI"), recognised to be the European authority most expert in the allergy vaccine field. The PEI has agreed to act as 'Reference Member State' for Europe-wide registration under the European Union Mutual Recognition Procedure ('MRP'). Following the German national phase, which is expected to take approximately one year, the MRP will commence.
In the initial phase of MRP, the Company has elected to apply for authorisation in the markets with the greatest revenue potential for Pollinex Quattro and, if the submission to the PEI is successful, approvals could be expected from 2010 with launches taking place in these countries across the following two years.
This is the first submission for an injected therapeutic allergy vaccine aimed at EU-wide approval and marks the culmination of a development programme in which the Company has invested more than £20 million over several years. The submission follows the positive outcome, announced last year, of Allergy Therapeutics' Pollinex Quattro Grass Phase III study, G301, the largest controlled allergy vaccine study ever conducted. The study met its primary efficacy endpoint and demonstrated that Pollinex Quattro has significant clinical benefits over placebo.
Keith Carter, Chief Executive of Allergy Therapeutics, said:
"Injected vaccines are the preferred immunotherapy option for allergy specialists because of the excellent compliance levels. As the injections are controlled by the physicians, they can ensure that the patients receive a full course of therapy. This is especially the case with Pollinex Quattro because of the ultra short four-shot dosing course.
"Completion of the regulatory process in the EU will open up new markets as well as enabling us to improve pricing and market share in those European countries where named patient sales are currently already possible.
"Pollinex Quattro Grass has already been through the most rigorous clinical evaluation of any allergy vaccine, delivering clear efficacy benefits as well as excellent levels of tolerability. We look forward to progressing the EU mutual recognition process.
"The development of a pharmaceutical from the pre-clinical stage to registration application by a single company, unpartnered, is a rare achievement in any market. For a small life sciences company to do so in a major disease is a first ever achievement in the United Kingdom biotech industry and represents a significant milestone for Allergy Therapeutics."
Prof Chris Corrigan, Department of Asthma, Allergy & Respiratory Science at King's College London School of Medicine, Guy's Hospital, said:
"The submission of Pollinex Quattro Grass brings closer the day when this ultra short course allergy vaccine will become widely available to patients and their physicians."
Allergy vaccine Company << sleeping Giant
The G301 study will form the basis of a submission in early 2009 to the European authorities for the licensure of Pollinex Quattro Grass << Will happen soon
Agy is a fantastic Opportunity ..Please do your own research
Allergy Therapeutics (AGY.L)
MarketCap .. 6 million GBP << 8,7 million US$
Price.. 7p
Major Shareholder
http://www.allergytherapeutics.com/Major-Shareholders.aspx
Presentation 2008
http://www.allergytherapeutics.com/uploads/1ginvestorpresentationsept2008final.pdf
Outlook
Over the coming months we shall be discussing the way forward with the European regulator regarding the approval of Pollinex Quattro Grass and we shall be continuing to prepare our sales and marketing operation across Europe for the launch of the product. In addition, we shall be continuing discussions with the FDA to lift the clinical hold on Pollinex Quattro in the US.
Allergy Therapeutics' core European business remains strong and growing, funded by its existing bank facilities and the cash it increasingly generates. As Allergy Therapeutics moves from the extended period of R&D and operational investment to a core-business focused operating company with growing sales generated by Pollinex Quattro, particularly once approved, its profit margins are expected to improve to the industry average, creating an attractive financial profile for investors.
EU Registration
The G301 study will form the basis of a submission in early 2009 to the European authorities for the licensure of Pollinex Quattro Grass, with the first registration anticipated in or before 2010. The initial target market will be Germany, followed by Italy, Spain, UK and Austria, in each of which we have an existing commercial infrastructure, and France and the Netherlands. These seven countries represent the biggest commercial potential in Europe for the product.
In summary, it has been a year of achievement after many years of investment and hard work by all involved. Allergy Therapeutics today has the first ever clinically proven ultra-short course allergy vaccine and we are poised for submission for registration with the operational infrastructure being prepared to exploit it.
Pivotal Phase III Studies
The successful outcome of G301, Allergy Therapeutics' pivotal Phase III study of Pollinex Quattro Grass, announced on 14 May 2008 was undoubtedly the most important event during the financial year. Conducted predominantly in the United States, G301 was the largest ever Phase III double blind placebo controlled study in the allergy vaccine field and to date is the only study of its type to achieve its primary efficacy endpoint.
After the financial year end we were delighted to learn that R301, a similar phase III trial with our Ragweed allergy vaccine, also met its primary efficacy endpoint which was particularly pleasing as this was the study most negatively effected by the FDA's clinical hold which occurred in the middle of the treatment phase of this study. At the time of writing the data is still being assessed, but achieving a phase III clinical trial end-point when fewer than 40% of the subjects were given the full four-shot treatment is very encouraging and speaks volumes for the efficacy of the Pollinex Quattro range.
Variability characterises clinical trials in the field of allergy. The pollen seasons vary from country to country, area to area, and year to year. The patients recruited into studies vary. The subjective assessment of symptom scores by patients in the studies is prone to variation. The compliance of the subjects to the study protocols is geographically highly variable. During 2007, three other allergy vaccine products were in Phase III studies in the United States and all 'failed'. One of these was a successful European product in the same allergen, in the same geography and even using some of the same study centres as G301. We are therefore very pleased that Pollinex Quattro has been successful in this most stringent of tests.
One of the striking features of the G301 outcome is the robustness of the result. All of the key prospectively defined analyses are positive, showing a robust, clear and statistically significant benefit over placebo. Another feature, which bodes well for the future patient experience with Pollinex Quattro, is the unusually high levels of compliance; all but 5% of the patients completed the course of treatment. In most allergy vaccine studies, including those of sub-lingual products where the main proposed advantage is patient convenience, the compliance levels have been significantly worse and of course in real life, outside the controlled conditions of the clinical trial, compliance is likely to be poorer still. The excellent compliance with Pollinex Quattro is explained by the small number of injections, just four, and the speed of the treatment; it can be completed in as little as three weeks and as close as three weeks to the start of the pollen season. We believe that the result in terms of patients actually receiving the treatment as intended by their physicians will make ultra-short course injected allergy vaccines the treatment of choice for allergy specialists and their moderate to severe allergic patients.
FDA seize contaminated heparin
Friday, November 07, 2008
As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.
The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.
"This action will help prevent this contaminated heparin from finding its way into the marketplace," said Mike Chappell, acting associate commissioner for regulatory affairs, FDA.
Heparin is a blood-thinning drug. An API is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. Heparin Sodium USP is an API that may be incorporated into finished drug products. Heparin Lithium is used in certain medical devices including vacutainer blood collection tubes, some in vitro diagnostic assays, and as a coating for capillary tubes. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.
OSCS contaminant in injectable drug products containing heparin has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008. Since then, the FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products contaminated with OSCS. The seized Celsus heparin - which had entered the United States before the establishment of import controls for the drug - was tested for the presence of OSCS as part of this FDA effort.
To date, the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.
The FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company's actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall. The agency advises manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.
The FDA has notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.
http://www.fda.gov/
Cerepro(R) Phase III results meet primary endpoint
some analyst comments ...
Ark therapeutics (AKT.L)
Marketcap: 139 million GBP ( 283 million US$ )
Cash : 65,1 million GBP ( 129 million US$ )
Price : 66p
Yesterday's trading: Biotech boosted by cancer drug
Geoff Foster, Daily Mail
31 July 2008, 7:33am
Followers of Britain's beleaguered biotech sector got a shot in the arm when Ark Therapeutics soared 32¾p to 80¼p on a hefty turnover of 6.3m shares.
Buyers dosed up with stock after hearing of positive results from the company's fourth Data Safety Monitoring Board review of the ongoing Phase III trial of its Cerepro brain cancer drug. It reported a 42-day improvement in patients' lifespan when Cerepro is added to standard of care treatment.
Ark's buoyant chief executive Nigel Parker said the firm is the first in the cutting-edge field of gene therapy to get a product into Phase III trials in cancer, and that in itself represents a significant breakthrough for medicine.
There is still a substantial amount of further information to come and the company will update the analysis in early 2009.
Samir Devani, analyst at Nomura Code, reckons the announcement significantly enhances the chances of Cerepro successfully reaching the market and gaining regulatory approval by the second half of 2009.
Fair value for the stock would then rise to £2, which compares with his current target price of around 135p.
-------
Ark gains on hopes for cancer drug
By Alistair Dawber
Thursday, 31 July 2008
Ark Therapeutics, the gene therapy group, gave the beleaguered UK biotech industry a shot in the arm yesterday when it said that the third phase trial of its brain cancer treatment, Cerepro, has shown good initial results and that it now expects to be able to market the drug by next year.
The company's shares rocketed on the news closing the day up 69 per cent at 80.25p. Ark had earlier said that the topline results of the tests showed that patients using the treatment were on average surviving 42 days longer than people not using Cerepro.
The results come from tests on 183 patients with the company expected to give details of another 53 cases early next year, after which it will apply to European regulators for a licence to sell the drug.
Ibraheem Mahmood, an analyst at Investec, said that while yesterday's news was encouraging, the real tonic for the group is that the positive tests validate Ark's gene based technology and that should lead to interest from some of the pharmaceutical giants. "While the news is certainly good, it is really only a by-product," he said. "Cerepro will be worth between about $500m and $1bn, but it is the first time that the technology has been shown to work and that makes it appealing to buyers."
The news will also be welcomed by the wider UK biotech market, which has a poor record of converting potential drugs in trial into commercial successes. In recent weeks two other groups, Alizyme and Oxford Biomedica, have disclosed pivotal phase three failures, which sent the share price of both companies crashing.
However, the news on Cerepro was not greeted with universal praise. KBC analyst Paul Cuddon pointed out that Cerepro will need to compete against existing medicines. "In order for the trial to be considered a success, and for the company to claim they have a blockbuster, it has to show that it is better than what is already out there, and these trials do not show that," he said. "Ark needed to show that Cerepro is more effective than Temador [another brain cancer treatment] and they have not done that. I still have major concerns."
Mr Mahmood countered that Temador, which had annual sales of $861m last year, has side effects akin to the symptoms suffered by AIDS sufferers, giving patients a poor quality of life.
Hep C trial for Biotron
Biotron commences phase Ib/IIa testing of HCV treatment
Dylan Bushell-Embling 07/08/2008 15:54:52
Biotron [ASX: BIT] has started Phase Ib/IIa clinical trials of its BIT225 hepatitis C candidate.
The study will enlist 18 hep C positive patients, who will be sorted into two dosage groups and a placebo control group.
The trial is primarily a safety and tolerability study, but determining the pharmacokinetics and effectiveness of the drug are secondary objectives of the trial.
Biotron expects to conclude the trial by the end of the year.
BIT225 targets the p7 protein of HCV, and has demonstrated good antiviral activity in surrogate models of HCV infection. This trial follows on from a successful Phase I trail conducted in healthy volunteers.
Biotron began as the commercialisation arm of the John Curtin School of Medical Research at ANU.
Cerepro(R) Phase III results meet primary endpoint
Ark Therapeutics Group PLC 30 July 2008
# Secondary endpoints yet to be established with 45% of patients still alive -
London, UK 30 July 2008 - Ark Therapeutics Group plc (AKT:LSE) today announces that the preliminary analysis of Study 904, a Phase III study of Cerepro(R), its novel gene-based therapy being developed as an Orphan Drug for the treatment of operable primary malignant glioma, demonstrates that the trial has met its primary endpoint. Cerepro(R) treatment resulted in significant improvements in median survival on the primary endpoint compared with various control groups. In the secondary endpoints, with 45% of patients still alive, benefits have yet to be established.
Study 904 was a multicentre, standard care controlled, pivotal trial in 236 patients designed, following advice from the EMEA, to confirm the safety and efficacy of Cerepro(R) in patients with operable high grade glioma (brain cancer) against current standard care treatment options. Patients were randomised to either standard care plus Cerepro(R) or standard care alone. Standard care was surgery and radiotherapy or surgery and radiotherapy followed by temozolomide, depending on the investigating centres' standard practice and patient suitability, giving four treatment groups. This allowed comparison of the efficacy of Cerepro(R) and temozolomide in the same trial without denying patients what physicians considered the appropriate established standard care. The primary endpoint was survival, defined as time to death or re-intervention(1). At randomisation, the treatment groups were well matched in terms of demographics and the standard prognostic features (age, Karnofsky Score etc).
The overall combined controls primary endpoint analysis in the Intention to Treat (ITT) population (n=236) compared Cerepro(R) with and without temozolomide against controls with and without temozolomide. It showed a 42 day improvement in median survival (310 days vs 268 days) and the improvement over standard care reached significance (p<0.032). The analysis was performed approximately 14 months after completion of recruitment.
On the primary endpoint, the group given Cerepro(R) and temozolomide showed an improvement of 68% in median survival time compared with standard care surgery and radiotherapy controls (350 days vs 208 days). Against the same controls, treatment with Cerepro(R) alone showed an improved median survival trend approaching 50%, similar to those given treatment with temozolomide alone after surgery and radiotherapy (300 days and 307 days respectively vs 208 days with standard care). Improvements in the combined Cerepro(R) and temozolomide treatment group (n=58) and temozolomide alone group (n=76) were significant (p<0.05). In the smaller Cerepro(R) alone treatment group (n=61), the effect is approaching significance (p<0.065) with 16% still to report an event. Of the total 53 patients still to report an event, only 7 are in the surgery and radiotherapy control group and thus confidence intervals and statistical significance levels in all treatment groups might be expected to improve with time.
On the secondary endpoints, which include MRI based progression, all-cause mortality, safety and quality of life, the effects of Cerepro(R) treatment have yet to be established with around 45% of patients still alive. Data from a further time point analysis are needed to fully elucidate this.
Whilst increases were observed in hemiparesis, aphasia and pyrexia following therapy, the serious adverse event reports for Cerepro(R) were in line with those in previous studies, indicating that the product has an acceptable safety profile.
An updated analysis will be conducted in January 2009 according to the plan and all patients with be tracked until death in accordance with the gene therapy regulations.
The results of the study are expected to be presented at the European Association of Neuro-Oncology in Barcelona on 11-14 September 2008.
Commenting on the results Dr David Eckland, R&D Director at Ark, said: "We are very gratified that Cerepro has demonstrated efficacy in this multi-centre Phase III gene therapy study. This is in keeping with our experience and expectation of the product and we now have further evidence to show Cerepro(R) has an anti-cancer effect. Our next steps are to complete the full analysis and meet with our EMEA rapporteur to determine the way forward."
Dr Nigel Parker, CEO at Ark, added: "This is the first gene therapy product to successfully reach its primary endpoint in a major Phase III trial. With a number of patients in the trial still to report an event, there is a substantial amount of further information to come and we will update the analysis after the turn of the year in parallel with our regulatory activities. Malignant glioma is one of the most aggressive of all human diseases and to have seen a positive effect for Cerepro(R) in this disease area is very encouraging. Ark's adenoviral delivery technology has the potential to deliver a new era of gene-based therapies for acute and chronic human disease."
(1) Re-intervention is defined as any kind of treatment (surgery, chemotherapy or radiotherapy) given to prolong survival after tumour recurrence.
A conference call for analysts will be held at 9.00am today, 30 July 2008. Please call Claire Rowell on 0207 269 7285 for details.
EPCT --Positive EU Opinion for Ceplene up 210%
Ceplene(R) Receives Positive European Opinion for Approval From CHMP
Friday July 25, 5:44 am ET
Marketing Authorization Normally Anticipated within 67 Days in the EU
Conference Call to be Held July 28 at 9:00 a.m. Eastern Time
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion regarding the marketing authorization for Ceplene® (histamine dihydrochloride), for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. Ceplene is to be administered in conjunction with low-dose interleukin-2 (IL-2). This positive opinion was issued following a request made by EpiCept to have the initial negative opinion of March 2008 re-examined by the CHMP. Ceplene has been designated as an orphan medicinal product, and as such is entitled to 10 years of marketing exclusivity in the EU.
ADVERTISEMENT
EpiCept attended an oral explanation hearing at the CHMP’s plenary meeting on July 22, 2008. Following this oral explanation, the CHMP recommended that Ceplene be granted a full marketing authorization under the provision of Exceptional Circumstances.
As part of granting of the marketing authorization under Exceptional Circumstances, EpiCept has agreed to perform two post-approval clinical studies. One of the studies seeks to further elucidate the clinical pharmacology of Ceplene by assessing certain biomarkers in AML patients in first remission. The other study will assess the effect of Ceplene/IL-2 on the development of minimal residual disease in the same patient population. EpiCept is entitled to seek further guidance on the design of such studies from the EMEA through the protocol assistance procedure.
“We are thrilled with the positive opinion reached by the CHMP and are pleased by the overwhelming support for Ceplene we received from key opinion leaders in hematology across Europe during this successful re-examination effort,” stated Jack Talley, President and CEO of EpiCept. “Ceplene, in conjunction with IL-2, is the first therapy shown to significantly prolong leukemia-free survival and prevent relapse in AML patients in first remission.”
The CHMP’s recommendation will now be forwarded to the European Commission for issuing a marketing authorization in the form of a Commission Decision, which normally occurs within 67 days. The marketing authorization with unified clinical usage for Ceplene granted under the Centralized Procedure will be valid for the entire European Union as well as in Iceland, Liechtenstein and Norway.
“We are highly optimistic about the commercial prospects for Ceplene and we intend to pursue its commercial introduction as expeditiously as possible,” continued Mr. Talley. “We are evaluating all of our strategic options for the marketing of Ceplene, and will continue to work towards realizing the drug’s potential to fulfill an important unmet medical need for AML patients in Europe.”
Conference Call
EpiCept announced that it will host a conference call to discuss this opinion and the Ceplene program on Monday, July 28, 2008 at 9:00 a.m. Eastern Daylight Time.
Undiscovered Stock....Allergy Vaccine Successful in PIII
Allergy Therapeutics (AGY.L)
http://finance.yahoo.com/q?s=agy.l
Marktkap: 29 million GBP ( 57,5 million US$ )
Cash: 8 million GBP ( 15,8 million US$ )
Kurs: 35 p
Pipeline:
http://www.allergytherapeutics.com/uploads/pipeline2.jpg
The vaccine that could cure hay fever forever
By JENNY HOPE - More by this author »
Last updated at 02:22am on 15th May 2008
http://www.dailymail.co.uk/news/article-566513/The-vaccine-cure-hay-fever-forever.html
15 May 2008
Allergy Therapeutics Pollinex Quattro Phase III trial meets efficacy goal UPDATE
LONDON (Thomson Financial) - Allergy Therapeutics plc (LSE: AGY.L - news) (Advertisement)
, the specialist pharmaceutical company focused on allergy vaccination, today announces positive results from its Pollinex Quattro Grass Phase III study, G301, the largest controlled allergy vaccine study ever conducted, it said.
The result clears the way for the company to apply for marketing approval in the European Union, with the submission planned for the first quarter of next year.
The company currently has development in the US on hold while the FDA has a clinical stay in place.
Keith Carter, chief executive officer of Allergy Therapeutics, said this is the most important piece of news in the 70-year history of the company.
He told Thomson Financial News in a telephone interview: 'We've invested very hard, this is why we went public to fund these trials and it's really great to be able to announce that it's all been worthwhile. Clearly this is a huge step forward not just for us but for allergen vaccination generally and for patients who suffer from allergies.'
He added that the trial also showed that Pollinex Quattro had a good safety profile and patients complied well with the dosing requirement.
Marketing director Kevin Wilkinson estimated that the market in Europe for allergy vaccines was about 500 million euro.
The announcement is expected to boost current sales of Pollinex Quattro, which are on a named-patient basis, as well as boost future sales after registration.
Carter explained that the announcement would help the company in licensing talks. 'We would like to partner to accelerate the introduction of the product across Europe and these results will allow us to have very meaningful conversations with partners,' he said.
Nomura Code Securities, in a note to clients, said it viewed the results as 'highly encouraging'.
'We view these results as highly encouraging for out-licensing prospects and EU approval. We continue to believe that the FDA clinical hold will be lifted and reiterate our 'Buy' recommendation with a price target of 118p, based only on approval and sales in the EU.'
At 10.16 am shares were up 26.96 percent, or 7.75 pence, to 36.5 pence/share, bringing the market capitalisation up to 24 million pounds.
Presentation March 2008
http://www.allergytherapeutics.com/uploads/InterimResultsPresentationMarch08Final.pdf
More Info
http://www.iii.co.uk/investment/detail?code=cotn:AGY.L&display=news&it=le
Another great Day
http://finance.yahoo.com/q?s=nri.to
Aberforth Partners increases stake in Ark Therapeutics....
to more than 10% and now holds 20,822,415 shares.
22 May 2008
http://moneyextra.uk-wire.com/cgi-bin/articles/200805221327020879V.html
Ark therapeutics (AKT.L)
Marketcap: 143 million GBP ( 283 million US$ )
Cash : 65,1 million GBP ( 129 million US$ )
Price : 70p
http://finance.yahoo.com/q?s=akt.l
HIGHLIGHTS
Cerepro(R) * Phase III study completes recruitment
* Two successful Data Safety and Monitoring Board ("DSMB")
meetings advise no major safety concerns and recommend
trial continuation
* Clearance from the EMEA of historically difficult
technical barriers represents major breakthrough for
Cerepro(R) and the new gene-based therapeutic area
overall
Trinam(R) * Special Protocol Assistance (SPA) opened for Phase III
trial
* US Recombinant DNA Advisory Committee (RAC) gives early
clearance for Phase III trial, expected to commence in
H1 2008
VitorTM * Successful pre-Phase III FDA and EMEA scientific advice
meetings. Pilot Phase III trial expected to commence
H1 2008
Pre-clinical * Three gene-based products being prepared for Phase
I/IIa trials
* Ark Therapeutics-led consortium awarded Euro2.5m European
Commission grant for baculoviral vectors research
* Scavidin(R) demonstrates pre-clinical effectiveness in
third cancer model
Wound care * Wound care portfolio strengthened with the addition of
Kerraped(R)
Corporate/ * Formal grant of key patent for stroke in Europe
Commercial * Placing and Open Offer completed in November, raising
£35.4m net of expenses
* Cash and money market investments of £65.1m at 31
December 2007 (£48.4m at 31 December 2006)
Post-period events * January 2008 DSMB meeting confirms timing of preliminary
results from Phase III Cerepro(R) trial due Q3 2008
* Acquisition of Lymphatix Oy strengthens gene research
technology and secures licences for VEGF C and VEGF
D genes
* Finnish manufacturing facility completes validation
review to USA standards
* Neuropad(R) in-licensed and launched in the UK
(see separate press release)
Pipeline Review
Pharmaceuticals
Cerepro(R)
Throughout 2007 we continued to manufacture commercial grade batches of Cerepro
(R) to the rigorous standards agreed with the EMEA. In the first half we
pioneered the process controls necessary for approval of adenoviral gene
medicines in Europe and we believe that the patents for these will, once
granted, help maintain our leading position for both Cerepro(R) and in this area
overall. At the end of 2006 the DSMB had reviewed the first 133 patients
recruited into the Cerepro(R) Phase III corroborative study and recommended the
study continue as planned. In early Q2 we completed recruitment of the full 250
patients and in July the DSMB again recommended continuation of the study. Also
in Q2, the EMEA concluded its first review of our application for conditional
marketing approval which we filed on the basis of the existing Phase II trials.
The EMEA concluded that whilst the critical chemistry and manufacturing controls
(CMC), pre-clinical and environmental sections appeared satisfactory and the
safety profile appeared acceptable, an approval based on efficacy from a limited
number of treated patients was insufficient for a new class of drug despite it
being an Orphan Drug. Additional proof of efficacy from the ongoing Phase III
corroborative study was requested by the EMEA as necessary for an approval.
Being cleared through the three key technical CMC, pre-clinical and
environmental sections of the marketing application is a major breakthrough for
Ark and for the biotech sector overall. It has effectively established that,
providing satisfactory clinical data exists, this type of gene medicine is an
approvable platform.
Consequently, since the conditional approval route was no longer the correct
process for an approval based on a full trials programme, the Company withdrew
its application and will apply for a full licence once the results of the
corroborative study are available. Following the January 2008 DSMB meeting,
these are scheduled for Q3 2008.
VitorTM
Following a successful pre-Phase III meeting with the EMEA and the FDA, the
Company applied for Special Protocol Assistance ("SPA") from the FDA. Once
granted, SPA allows the final Phase III programme to be designed with the US
regulators such that, if successful, a rapid review process takes place. Whilst
SPA can delay commencement of the Phase III programme, it usually achieves a
greater time-saving during the approval process and reduces the risk of a
programme design problem preventing an approval. The SPA process opened in Q2
and, following a number of consultation and review meetings with the FDA, the
Company decided to run a pilot Phase III to obtain extra data not available from
early studies, prior to concluding the SPA. Whilst this has delayed the start
of the Phase III programme by around a year, Ark believes this sensible and
cautious approach is correct to ensure the appropriate Phase III programme is
conducted. Recruitment of the first patient is expected H1 2008.
Trinam(R)
The end of Phase II meeting with the FDA in 2006 resulted in Ark being offered
SPA for the Phase III development. In the first half of the year we filed the
relevant applications to the US recombinant advisory committee ("RAC") and to
the FDA to open the SPA. We were encouraged that attitudes to gene medicine in
the US had also advanced when rapid clearance for the Trinam Phase III was given
by RAC mid year, without the need for an oral hearing. The SPA progressed
steadily during the rest of the year and we conducted a further pre-clinical
study, as requested by the FDA, to expand the number of operative procedures for
which Trinam(R) might be used. Whilst we had hoped to conclude the SPA in 2007,
the outbreak of foot and mouth disease in the UK stopped animal movements and
caused us a three month delay, but work was completed at the end of the year and
the SPA process is expected to conclude shortly.
Pre-clinical Research
Our pre-clinical programmes have shown considerable advancement in 2007 and we
have increasingly focused our efforts on the DNA-based areas of our research
where our skill base and resources are world-leading. In January 2007 we held
our first R&D day for analysts and investors at our Kuopio facility. The day
was well attended and gave us the opportunity to show the size and scope of our
new research and manufacturing facilities and to introduce the results of some
of our most promising research programmes. These are advancing the way DNA can
be used as highly selective medicines in conditions where existing treatments
and old pharmaceutical chemistry based approaches are inadequate. We were very
pleased with the positive response from attendees and the coverage which we
received.
In February we announced a Euro2.5m consortium grant to undertake pioneering work
in the use of insect-derived baculoviruses to further their use in the gene
medicine area. Further pre-clinical proof-of-principle results were obtained
mid year for our Scavidin(R) product which showed efficacy in a third cancer
model, giving us confidence to plan the final pre-clinical work and associated
GMP manufacturing to take the product into clinical development. In Q3 we
showed for the first time the extremely exciting results for our VEGF work in
the ischaemic myocardium using the same adenoviral delivery technology as in
Cerepro(R) and Trinam(R). In Q4 we also showed the market further pre-clinical
results for our DNA-based medicines in the areas of foetal growth restriction,
wound healing and coronary artery bypass graft. These are all serious areas of
unmet clinical need, in which our understanding of the disease at the molecular
biology level is enabling us to develop second generation gene medicine products
where the therapeutic gene can be optimised to the problem and be delivered via
our established adenoviral platform.
Late in the year we concluded negotiations with Lymphatix Oy, a Helsinki-based
private biotech company and acquired the business in an all-share transaction at
the start of 2008. This acquisition has given us access to certain scientific
technologies to speed up our pre-clinical programmes, as well as a licence to
the angiogenic and lymphangiogenic applications for VEGF-D and C.
We are also moving towards lead optimisation with our Neuropilin-1 antagonist
programme and our targeted vector and earlier gene science research continues to
advance. Our goal is to move three of our most promising pre-clinical products
through to the first human studies, to gain key first efficacy data in the
target disease.
The strength and quality of our pre-clinical science was reinforced this year by
the European Euro2.5m baculovirus grant, where our application achieved one of the
highest scores possible in review, and by the successful Q4 fundraising where
significant proceeds were raised to progress the pre-clinical gene-based
programmes.
Patent Portfolio Update
In 2007 Ark had 36 new patents granted including the important "ACE stroke"
patent for Europe. We filed 14 new applications and, in accordance with our
constant review policy, abandoned 12 which we felt had no clear commercial
value. At present Ark has 186 patents granted and 160 pending applications and
we continue to demonstrate success in overcoming the various objections and
oppositions in the prosecution process. In the latter part of 2007 we filed
applications covering manufacturing processes which, if granted, would give our
gene-based products protection until 2027.
Wound Care Business
Combined sales of our wound care products showed good growth in 2007. Overall,
our ex-warehouse sales averaged an increase of 66% over 2006. Whilst our wound
care business is still relatively small, we are pleased with the growth and we
believe we are seeing some signs that the NHS is beginning to move from a
containment mode towards an optimisation mode where Ark's new product range,
which stands up to the latest health economic scrutiny, should do well.
Late in the period we introduced Kerraped(R), a special medical shoe which
off-loads pressure from the areas of the foot most prone to diabetic ulcers.
This is the first product of this class to receive reimbursement in the UK.
Early signs are that the market has received the product enthusiastically and
first sales occurred at the very end of the year. Very recently, we have
introduced the Neuropad(R) diagnostic test, to detect peripheral autonomic
neuropathy in the feet of diabetic patients, to UK podiatrists and we will
continue to add further new products to the business to build scale in this
challenging UK healthcare environment.
Summary and Outlook
In 2007 we made substantial progress. The pioneering work on regulatory
standards for gene therapy, progressing our other leads towards Phase III and
the grant of the European stroke patent are some of the most important
achievements in the history of the Company. This success, together with our
pre-clinical progress, catalysed the Placing and Open Offer which has allowed us
to strengthen considerably our balance sheet, thus securing the next stage of
the Company's development and building on our leading position in the gene
therapy area.
During 2008 we expect to maintain this momentum. Our manufacturing facility
recently achieved US production validation standards. Trinam(R) and VitorTM are
expected to enter Phase III studies and we will report the results of the
Cerepro(R) Phase III study. We already have the sales and marketing plan for
launch in place and key managers identified. 2008 should also bring further
developments in the commercialisation of our stroke patent and we expect to
introduce further wound care products to market in the UK. With the Lymphatix
acquisition and strong cash reserves we also expect to make significant progress
with the late stage pre-clinical programmes, moving them towards Phase I/IIa
development in consultation with regulators. We are very excited by our
achievements in 2007 and, whilst there are still some major challenges ahead, we
look forward to translating these plans into reality with confidence.
Undiscovered Stock....Allergy Vaccine Successful in PIII
Allergy Therapeutics (AGY.L)
Marktkap: 29 million GBP ( 57,5 million US$ )
Cash: 8 million GBP ( 15,8 million US$ )
Kurs: 35 p
Pipeline:
http://www.allergytherapeutics.com/uploads/pipeline2.jpg
The vaccine that could cure hay fever forever
By JENNY HOPE - More by this author »
Last updated at 02:22am on 15th May 2008
http://www.dailymail.co.uk/news/article-566513/The-vaccine-cure-hay-fever-forever.html
15 May 2008
Allergy Therapeutics Pollinex Quattro Phase III trial meets efficacy goal UPDATE
LONDON (Thomson Financial) - Allergy Therapeutics plc (LSE: AGY.L - news) (Advertisement)
, the specialist pharmaceutical company focused on allergy vaccination, today announces positive results from its Pollinex Quattro Grass Phase III study, G301, the largest controlled allergy vaccine study ever conducted, it said.
The result clears the way for the company to apply for marketing approval in the European Union, with the submission planned for the first quarter of next year.
The company currently has development in the US on hold while the FDA has a clinical stay in place.
Keith Carter, chief executive officer of Allergy Therapeutics, said this is the most important piece of news in the 70-year history of the company.
He told Thomson Financial News in a telephone interview: 'We've invested very hard, this is why we went public to fund these trials and it's really great to be able to announce that it's all been worthwhile. Clearly this is a huge step forward not just for us but for allergen vaccination generally and for patients who suffer from allergies.'
He added that the trial also showed that Pollinex Quattro had a good safety profile and patients complied well with the dosing requirement.
Marketing director Kevin Wilkinson estimated that the market in Europe for allergy vaccines was about 500 million euro.
The announcement is expected to boost current sales of Pollinex Quattro, which are on a named-patient basis, as well as boost future sales after registration.
Carter explained that the announcement would help the company in licensing talks. 'We would like to partner to accelerate the introduction of the product across Europe and these results will allow us to have very meaningful conversations with partners,' he said.
Nomura Code Securities, in a note to clients, said it viewed the results as 'highly encouraging'.
'We view these results as highly encouraging for out-licensing prospects and EU approval. We continue to believe that the FDA clinical hold will be lifted and reiterate our 'Buy' recommendation with a price target of 118p, based only on approval and sales in the EU.'
At 10.16 am shares were up 26.96 percent, or 7.75 pence, to 36.5 pence/share, bringing the market capitalisation up to 24 million pounds.
Presentation March 2008
http://www.allergytherapeutics.com/uploads/InterimResultsPresentationMarch08Final.pdf
More Info
http://www.iii.co.uk/investment/detail?code=cotn:AGY.L&display=news&it=le
Nuvo Research -- Good Volume today up 15%
Marktkap: 37,4 million C$
Cash : 19 million C$
http://finance.yahoo.com/q?s=nri.to&x=0&y=0
Presentation....must read
http://www.nuvoresearch.com/documents/2007%20-%20Investor%20Presentation.pdf
Nuvo Research -- Good Volume today up 15%
Marktkap: 37,4 million C$
Cash : 19 million C$
http://finance.yahoo.com/q?s=nri.to&x=0&y=0
Presentation....must read
http://www.nuvoresearch.com/documents/2007%20-%20Investor%20Presentation.pdf
Nuvo Research -- Insider Activity
http://canadianinsider.ca/coReport/allTransactions.php?ticker=nri