Celox sent me this report comparing Hemcon and Z-medica with Celox HERE (its a verified safe Pdf download from adrive).
Given the positive results I was left wondering why this product was not the sole choice of the Military, in particular the US forces?
So I emailed Craig Hardy, CEO, MedTrade Products Ltd and asked him........
Me: According to the Jan. ’08 Portsmouth pdf study (comparing Celox with Hemcon and Z-medica’s, Quikclot) the results indicate Celox shows a 100% survival rate. Is this product currently undergoing any evaluation by the military?
Craig: Yes. Celox is used in some performance critical areas of the military and being evaluated in many others. Its an ongoing process.
Me: Given that Medtrade is a U.K. based company what (if any) impact has this had for the uptake of Celox by the U.S. military?
Craig: In the US, Celox is distributed to the Military through Sam Medical in Portland Oregon. The UK is a very close ally of the US. We have heard of no decisions made on the basis of location. However our head office location means we are not as politically connected as some competitors and I believe this may have a significant effect.
Sunday, June 8, 2008
Saturday, June 7, 2008
ZymoGenetics to Webcast Presentation at Needham Conference
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ: ZGEN) announced today that James A. Johnson, Executive Vice President and Chief Financial Officer, will provide an update on company activities at the Needham Biotechnology and Medical Technology Conference in New York on Wednesday, June 11, 2008 at 11:30 a.m. Eastern Time.
A live webcast of the presentation can be accessed by going to: www.zymogenetics.com. The webcast will be archived for 30 days.
Here are some slides from a previous presentation
A live webcast of the presentation can be accessed by going to: www.zymogenetics.com. The webcast will be archived for 30 days.
Here are some slides from a previous presentation
Thursday, June 5, 2008
Orthovita to Present at the Seventh Annual Biotechnology and Medical Technology Conference
MALVERN, Pa.--(BUSINESS WIRE)--Orthovita, Inc. (NASDAQ:VITA), a spine and orthopedic biosurgery company, announced today that it will present at the Needham & Company, LLC Seventh Annual Biotechnology and Medical Technology Conference in New York. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Thursday, June 12th, at 2:30 p.m. Eastern Time, at The New York Palace Hotel, 455 Madison Avenue, New York, NY. A live audio webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting HERE.
Wednesday, June 4, 2008
Entegrion
Just received this video to share with you of Entegrion created Stasilon and its mode of action.
Haemacure Achieves Major Milestone - Starts Processing Plasma in Its New Fractionation Facility
MONTREAL, June 4 /CNW Telbec/ - Haemacure Corporation (TSX : HAE), aMontreal-based specialty bio-therapeutics company developing high-value humanplasma-derived protein products for commercialization, announces that it has started processing plasma in its new fractionation facility for the production of its proprietary all-human fibrin sealant for pivotal Phase II/Phase IIIclinical trials, leading to commercial launch. Haemacure has reached an important milestone this week with the commencement of plasma fractionation in its new manufacturing facility.Haemacure also confirms that it is on schedule and on budget to produce clinical material during the third quarter of 2008 and file an amendment to its existing IND with the U.S. Food and Drug Administration during the fourth quarter of 2008, in order to begin clinical trials in the first quarter of2009. The new fractionation facility incorporates the Hynetics(R) single-use bio-processing plastic containers technology, which has resulted in significant savings in capital expenditures and will also result in significant savings in operating costs, as compared to a stainless steel facility. The use of this technology also minimizes the risks
of cross-contamination between production batches. "Now that our fractionation facility is operational and that we have started processing plasma, Haemacure is truly engaged in its transformation from a development to a manufacturing company." said Joseph Galli, Chairmanand CEO of Haemacure. "The upcoming availability of clinical material willenable Haemacure to pursue its clinical plans in hemostasis and to expand into additional indications, such as adhesion prevention." concluded Mr. Galli.
Tuesday, June 3, 2008
Plasma Derived Products:Pathogen Safety of EVITHROM™
Here is a link through to a presentation by Bernard Horowitz, Ph.D. discussing the safety of (Omrix manufactured) J&J's Evithrom, you have to register first.
Omrix do concede that "Our products are derived from human plasma, and are therefore subject to the risk of biological contamination inherent in plasma-derived products. This risk could adversely affect our ability to obtain raw materials and market our products. " In THIS document
Info from Omrix Biopharmaceuticals tells us Bernard Horowitz, Ph.D. has served as a member of our Board since February 2006. Since January 2000, he has been a principal of Horowitz Consultants, LLC, a company providing assistance in strategic planning, process development, viral safety, clinical trial design and new product regulatory compliance. From 1995 to 1999, Dr. Horowitz served as chief scientific officer, executive vice president and director of V.I. Technologies, Inc., now Panacos Pharmaceuticals, Inc., a now publicly held company he helped found as a spin-out from the New York Blood Center. Dr. Horowitz has served as a scientific consultant to the National Institutes of Health, the Food and Drug Administration, the National Hemophilia Foundation, the International Association of Biological Standardization, and the World Health Organization. Dr. Horowitz is a co-inventor of over 25 issued U.S. patents. Dr. Horowitz received his B.S. in biology from the University of Chicago and his Ph.D. in biochemistry from Cornell University Medical College. He is a director of Protein Therapeutics, Inc.
US Department of Defense Recommends Soldiers Carry WoundStat™
BETHESDA, Md.--(BUSINESS WIRE)--TraumaCure Inc. announced today that the DOD Joint Committee on Tactical Combat Casualty Care (CoTCCC) has recommended that U.S. soldiers from all services carry the company’s hemostatic agent, WoundStat™. The CoTCCC based its recommendations upon the results of extensive studies conducted by both the Army’s Institute for Surgical Research (ISR) and the Naval Medical Research Center (NMRC). In those studies, no other product was as effective across the board in terms of survival, post treatment blood loss, and duration of hemostasis.
This is the first time ever that all branches of the military have come together and jointly recommended the same product for the most severe injuries involving high-pressure bleeding.
“Severe bleeding is the number one cause of death for soldiers injured in battle. The ISR study clearly shows WoundStat works consistently to stop serious bleeding quickly. In light of these study results, WoundStat will be a critical product in the field available to all soldiers in harm’s way, where and when it is needed most,” said Ron Blanck, retired US Army Surgeon General. “Approximately 80% of injuries in the current conflict are from improvised explosive devices (IEDs), which result in the severe and irregular wounds that WoundStat is specifically designed to treat. In those situations, WoundStat works in seconds, not minutes.”
Four different studies—including the one conducted by the Army’s ISR, along with others conducted at Virginia Commonwealth University, the Air Force, and NAMSA—have now proven that WoundStat is the most effective hemostat available for high pressure arterial wounds. In each of these studies, WoundStat was the only product that resulted in 100% survival. The novel wound treatment works through standing blood and has the added advantage that, should re-bleeding occur, a wound can be re-packed with the WoundStat already present—a real advantage in combat conditions.
“The Joint Committee on TCCC recognized WoundStat’s overall advantage in both effectiveness and safety. It is now clearly proven that, with its consistent reliability and efficacy, combined with its speed of use, WoundStat offers the highest level of operational field capability for our warfighters,” noted Devinder S. Bawa, CEO of TraumaCure.
TraumaCure has enough WoundStat in stock to equip every soldier currently deployed in the Middle East theater. The cost of WoundStat is about one-third that of the product the Army has been using for the past several years. WoundStat is also available for domestic use by emergency responders and others who need to be prepared for treating traumatic injuries.
Monday, June 2, 2008
Recothrom, Evithrom, Thrombin JMI
Anyone interested in Thrombin, Zymogenetics, King and J&J should follow this blog by Joe Tartakoff.
During last week's ZymoGenetics conference call, Ed Tenthoff of Piper Jaffray asked ZymoGenetics CEO Bruce Carter if he was noticing any moves by Johnson & Johnson.
Here's the exchange:
Tenthoff: Can you just update us on where pricing is for RECOTHROM and how some of the competitors have responded, and there's, you know, we've noticed very little in terms of noise from Evithrom ...
Carter: With the bovine thrombin, we are seeing a limited discounting... And like your search for J & J (Johnson & Johnson), I guess it's fair to say they are out there, but perhaps not as much as one might have expected from the name Johnson & Johnson. In fact, I could go stronger, surprisingly little considering it's Johnson & Johnson.
Omrix Biopharmaceuticals, which sells Evithrom along with Johnson & Johnson, begs to disagree.
During Omrix's conference call to report its results, CEO Robert Taub was asked how he would characterize "your market share for thrombin versus competitors, including both King and ZymoGenetics."
His response:
"I think we -- well we'll put it this way. Obviously our market share of thrombin is lower than King and it is higher than ZymoGenetics."
Then, another analyst pressed him on why that was the case, considering that the conceptual risks associated with cow-derived thrombin (that patients would develop antibodies against the product) would probably be the same with a human-derived one.
Taub's response:
Bovine thrombin has been around for so many years, and the arguments about antibody formation, it's not very convincing and you have to be very careful. I heard that the FDA gave a warning just two or three days ago to some very aggressive promotional literature by ZymoGenetics on that. So the need, if you want, to change is not very high. So I think what's really driving it is contracts, introduction in the hospitals, bundling, and sales mention and service at this stage.
Still, Taub conceded that the thrombin market was a difficult one to break.
In a release last week announcing its first-quarter results, the company said Evithrom sales "continue moderate growth." Read the release here.
And during the call, Taub used the word "slow" twice to refer to the market for thrombin:
... As we have expected the stand-alone thrombin market is and will change slowly. It's a slow process. While stand-alone thrombin will continue to to be an important product, we also continue to believe that long-term thrombin growth will ultimately be driven by thrombin-based enhanced hemostats, where thrombin is combined with other agents such as various forms of gelatin and which will be easier to use.
Overall, it seems that Evithrom is running into many of the same hurdles as ZymoGenetics, which is having to wait for hospitals that have used the King product for years to vote to allow the use of Recothrom.
Taub:
... There seem to be very low awareness of any risks related to bovine thrombin. And the manufacture of bovine thrombin has been sitting on their market position for a long time and the ramp up is slow, because of the P&T (hospital) committees, and these contracts that have to be done... There is also less way to innovate unless you develop, which we are planning and doing with J & J.
Source: SeattlePI
During last week's ZymoGenetics conference call, Ed Tenthoff of Piper Jaffray asked ZymoGenetics CEO Bruce Carter if he was noticing any moves by Johnson & Johnson.
Here's the exchange:
Tenthoff: Can you just update us on where pricing is for RECOTHROM and how some of the competitors have responded, and there's, you know, we've noticed very little in terms of noise from Evithrom ...
Carter: With the bovine thrombin, we are seeing a limited discounting... And like your search for J & J (Johnson & Johnson), I guess it's fair to say they are out there, but perhaps not as much as one might have expected from the name Johnson & Johnson. In fact, I could go stronger, surprisingly little considering it's Johnson & Johnson.
Omrix Biopharmaceuticals, which sells Evithrom along with Johnson & Johnson, begs to disagree.
During Omrix's conference call to report its results, CEO Robert Taub was asked how he would characterize "your market share for thrombin versus competitors, including both King and ZymoGenetics."
His response:
"I think we -- well we'll put it this way. Obviously our market share of thrombin is lower than King and it is higher than ZymoGenetics."
Then, another analyst pressed him on why that was the case, considering that the conceptual risks associated with cow-derived thrombin (that patients would develop antibodies against the product) would probably be the same with a human-derived one.
Taub's response:
Bovine thrombin has been around for so many years, and the arguments about antibody formation, it's not very convincing and you have to be very careful. I heard that the FDA gave a warning just two or three days ago to some very aggressive promotional literature by ZymoGenetics on that. So the need, if you want, to change is not very high. So I think what's really driving it is contracts, introduction in the hospitals, bundling, and sales mention and service at this stage.
Still, Taub conceded that the thrombin market was a difficult one to break.
In a release last week announcing its first-quarter results, the company said Evithrom sales "continue moderate growth." Read the release here.
And during the call, Taub used the word "slow" twice to refer to the market for thrombin:
... As we have expected the stand-alone thrombin market is and will change slowly. It's a slow process. While stand-alone thrombin will continue to to be an important product, we also continue to believe that long-term thrombin growth will ultimately be driven by thrombin-based enhanced hemostats, where thrombin is combined with other agents such as various forms of gelatin and which will be easier to use.
Overall, it seems that Evithrom is running into many of the same hurdles as ZymoGenetics, which is having to wait for hospitals that have used the King product for years to vote to allow the use of Recothrom.
Taub:
... There seem to be very low awareness of any risks related to bovine thrombin. And the manufacture of bovine thrombin has been sitting on their market position for a long time and the ramp up is slow, because of the P&T (hospital) committees, and these contracts that have to be done... There is also less way to innovate unless you develop, which we are planning and doing with J & J.
Source: SeattlePI
Haemacure Reports on Financing Progress
MONTREAL, June 2 /CNW Telbec/ - Haemacure Corporation (TSX : HAE), a Montreal-based specialty bio-therapeutics company developing high-value humanplasma-derived protein products for commercialization, provides financing update and reports on second quarter results. Financing As a result of the commitments Haemacure has received to-date from key shareholders to exercise their Series B warrants, the Corporation is wellpositioned to meet its objective of commencing the fibrin sealant pivotalPhase II/Phase III clinical trials. The Corporation remains on schedule and onbudget with the construction of its manufacturing facility. "We are very appreciative and encouraged by the strong 
support we have received from our major shareholders, Firebird Management and PinetreeCapital, as demonstrated through the exercise of their Series B warrants."said Joseph Galli, Chairman and CEO of Haemacure. "This support, coupled with the recent addition of Reinaldo Diaz to our Board of Directors and the hiring of senior managers at our facility, are elements of our value creation strategy that will make Haemacure a significant player on the global scale."concluded Mr. Galli.
Reinaldo M. Diaz
Reinaldo Diaz has over 25 years of experience in the biopharmaceutical industry. Prior to joining Celtic Pharma, he was Managing Member and Co-Founder of D&A Capital Management, LLC (“D&A Capital”), a firm focused on asset management and providing advisory services to companies in the Healthcare sector, particularly biopharmaceutical companies. D&A Capital, through affiliated entities, managed the Delta Opportunity Funds (“Delta”), a group of hedge funds with over $100 million in assets under management.
support we have received from our major shareholders, Firebird Management and PinetreeCapital, as demonstrated through the exercise of their Series B warrants."said Joseph Galli, Chairman and CEO of Haemacure. "This support, coupled with the recent addition of Reinaldo Diaz to our Board of Directors and the hiring of senior managers at our facility, are elements of our value creation strategy that will make Haemacure a significant player on the global scale."concluded Mr. Galli.Reinaldo M. Diaz
Reinaldo Diaz has over 25 years of experience in the biopharmaceutical industry. Prior to joining Celtic Pharma, he was Managing Member and Co-Founder of D&A Capital Management, LLC (“D&A Capital”), a firm focused on asset management and providing advisory services to companies in the Healthcare sector, particularly biopharmaceutical companies. D&A Capital, through affiliated entities, managed the Delta Opportunity Funds (“Delta”), a group of hedge funds with over $100 million in assets under management.
Novo Nordisk and Neose Announce Completion of Initial Phase 1 Clinical Trial
COPENHAGEN, Denmark & HORSHAM, Pa.--(BUSINESS WIRE)--Novo Nordisk A/S (NYSE:NVO) and Neose Technologies, Inc. (Nasdaq GM:NTEC) today announced that Novo Nordisk has completed the initial Phase 1 clinical trial with NN7128 (GlycoPEGylated Factor VIIa), a long-acting version of NovoSeven® Coagulation Factor FVIIa (Recombinant) administered intravenously. The trial assessed the safety and pharmacokinetics of NN7128 in 30 healthy subjects.
In the trial a significant prolongation of the half-life of NN7128 was observed. Furthermore, single doses of NN7128 were well tolerated with no serious adverse events.
“We are pleased to report the successful completion of this Phase 1 study and to have demonstrated a prolonged half-life of NN7128,” said Søren Bjørn, Corporate Vice President, Biopharm Research at Novo Nordisk. “As we continue our analysis of the data collected in this study, we look forward to presenting the full results at upcoming scientific and medical meetings.”
“We are encouraged by the safety and pharmacokinetic profile that NN7128 has demonstrated in this Phase 1 study,” said George J. Vergis, Ph.D., Neose President and Chief Executive Officer. “We look forward to continued progress in the clinical development of this compound.”
In the trial a significant prolongation of the half-life of NN7128 was observed. Furthermore, single doses of NN7128 were well tolerated with no serious adverse events.
“We are pleased to report the successful completion of this Phase 1 study and to have demonstrated a prolonged half-life of NN7128,” said Søren Bjørn, Corporate Vice President, Biopharm Research at Novo Nordisk. “As we continue our analysis of the data collected in this study, we look forward to presenting the full results at upcoming scientific and medical meetings.”
“We are encouraged by the safety and pharmacokinetic profile that NN7128 has demonstrated in this Phase 1 study,” said George J. Vergis, Ph.D., Neose President and Chief Executive Officer. “We look forward to continued progress in the clinical development of this compound.”
Subscribe to:
Posts (Atom)