A novel handheld device delivers a powder based on collagen to help surgeons achieve hemostatic bleeding control during surgical procedures.
The Biom’Up (Saint-Priest, France) HemoBlast Bellows is a sterile delivery device that is preloaded with a dry, sterile powder made of highly purified porcine collagen, glucose, chondroitin sulfate, and thrombin. The hemostatic powder is applied to the source of the bleeding by squeezing the bellows. Once applied, the powdered collagen and glucose components start the coagulation process by absorbing blood, concentrating coagulation factors and platelets, and providing a surface for autologous coagulation to begin.
In addition to collagen, the thrombin component, collected from pooled human plasma (an ancillary blood derivative) is included in the powder to boost the effect of the hemostatic agent. The thrombin facilitates the conversion of fibrinogen to fibrin, which allows the blood to clot. The chondroitin sulfate powder component provides cohesion between the hemostatic wound and the surrounding tissue. Users do not need to thaw, mix, or heat the powder, which is absorbed by the body within four weeks.
“As the first active hemostatic powder, it will support surgeons in their care for their patients with a simple, effective, and holistic solution for the management of bleeding” said Etienne Binant, CEO of Biom’up. “Biom'up has created innovative and clinically proven products that cover many different surgical specialties - orthopedics, spinal, cardiac, general, and maxillo-facial and dental.”
Studies have shown that during general surgical procedures, the HemoBlast Bellows device achieved 93% efficacy for hemostasis within six minutes, with a significantly shorter preparation time. Common adverse events included abnormal bloodwork, anemia, arrhythmia, and pain, none of which were related to the device itself. No unanticipated adverse device effects occurred.
Collagen is the main structural protein of connective tissue, making up 25-35% of the whole-body protein content. It is one of the body’s key natural resources and a component of skin tissue that can benefit all stages of the wound healing process. The importance of re-establishing a functional extracellular matrix (ECM) in chronic wounds has led to a renewed interest in collagen-based wound healing products, which can be applied either in the surgical or clinical setting, serving as a natural wound dressing with properties that artificial wound dressings do not possess.
Showing posts with label thrombin. Show all posts
Showing posts with label thrombin. Show all posts
Tuesday, January 2, 2018
Hemostasis Solution Controls Bleeding during Surgery
Labels:
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Collagen,
powdered agents,
thrombin
Monday, November 3, 2014
Monday, August 5, 2013
Medicines Co. wraps $240M deal to buy ProFibrix following PhIII success
The Medicines Company has swooped in to buy out the Dutch biotech ProFibrix, chipping in $90 million in cash on top of a $10 million option anted up in June as Phase III data on a lead surgical therapy loomed. And the buyer has agreed to pay up to $140 million more for a set of unspecified milestones.
The Medicines Company ($MDCO) is landing Fibrocaps in the deal, an easy-to-use dry-powder formulation of fibrinogen and thrombin that can be used to stop bleeding during surgery, a process referred to as hemostasis. In their release today the companies noted that the lead biologic hit all primary and secondary endpoints on four surgical indications: spinal surgery, hepatic resection, soft tissue dissection and vascular surgery. Investigators recruited 719 patients for the Phase III study.
The plan now is to file for EU approval in the fourth quarter of this year, with an FDA application following in the first quarter of 2014, commented ProFibrix CEO Jan Ohrstrom. And The Medicines Company believes it can earn more than $300 million a year on the product, provided it wins key approvals.
"The company was founded in 2007 with an A round from Index Ventures," adds Ohrstrom. Phase I was run in 2008 and investigators are now wrapping a 5-year clinical program, with more work scheduled on laparoscopic surgery as well as a pediatric program. The CEO says more indications are also being "toyed with," but he declined to elaborate. The company's lab in Leiden will stay operational, says Ohrstrom, the former chief medical officer of ZymoGenetics. ProFibrix currently has 25 employees in Leiden and Seattle, where it has a clinical development site.
"Subject to regulatory approval, we believe Fibrocaps can become an important hemostatic product--complementary to Recothrom (Thrombin, topical [Recombinant])," says Clive Meanwell, the CEO at The Medicines Co. "We anticipate leverage of our work with U.S. surgery centers and entry into the European market. … ProFibrix also has a proprietary recombinant fibrinogen development program which potentially allows us to create the world's first recombinant thrombin and recombinant fibrinogen combination products. We plan to integrate the ProFibrix team with our existing Recothrom team--expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering and improve the economic efficiency of leading hospitals worldwide."
The market for hemostatic products has been busy with new developments for years. Just a few weeks ago Omrix Biopharmaceuticals won a recommendation from the CHMP in Europe for the sealant matrix Evarrest, which also combines fibrinogen and thrombin. But The Medicines Company is hoping that ProFibrix's off-the-shelf technology will quickly win converts.
The Medicines Company ($MDCO) is landing Fibrocaps in the deal, an easy-to-use dry-powder formulation of fibrinogen and thrombin that can be used to stop bleeding during surgery, a process referred to as hemostasis. In their release today the companies noted that the lead biologic hit all primary and secondary endpoints on four surgical indications: spinal surgery, hepatic resection, soft tissue dissection and vascular surgery. Investigators recruited 719 patients for the Phase III study.
The plan now is to file for EU approval in the fourth quarter of this year, with an FDA application following in the first quarter of 2014, commented ProFibrix CEO Jan Ohrstrom. And The Medicines Company believes it can earn more than $300 million a year on the product, provided it wins key approvals.
"The company was founded in 2007 with an A round from Index Ventures," adds Ohrstrom. Phase I was run in 2008 and investigators are now wrapping a 5-year clinical program, with more work scheduled on laparoscopic surgery as well as a pediatric program. The CEO says more indications are also being "toyed with," but he declined to elaborate. The company's lab in Leiden will stay operational, says Ohrstrom, the former chief medical officer of ZymoGenetics. ProFibrix currently has 25 employees in Leiden and Seattle, where it has a clinical development site.
"Subject to regulatory approval, we believe Fibrocaps can become an important hemostatic product--complementary to Recothrom (Thrombin, topical [Recombinant])," says Clive Meanwell, the CEO at The Medicines Co. "We anticipate leverage of our work with U.S. surgery centers and entry into the European market. … ProFibrix also has a proprietary recombinant fibrinogen development program which potentially allows us to create the world's first recombinant thrombin and recombinant fibrinogen combination products. We plan to integrate the ProFibrix team with our existing Recothrom team--expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering and improve the economic efficiency of leading hospitals worldwide."
The market for hemostatic products has been busy with new developments for years. Just a few weeks ago Omrix Biopharmaceuticals won a recommendation from the CHMP in Europe for the sealant matrix Evarrest, which also combines fibrinogen and thrombin. But The Medicines Company is hoping that ProFibrix's off-the-shelf technology will quickly win converts.
Labels:
fibrinogen,
fibrocaps,
ProFibrix,
recombinant,
recothrom,
thrombin
Sunday, May 12, 2013
RECOTHROM Becomes the First and Only Topical Thrombin Indicated for Use in Children Greater Than or Equal to One Month of Age
PARSIPPANY, NJ--(Marketwired - May 9, 2013) - The Medicines Company (NASDAQ : MDCO ) today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for RECOTHROM®, Thrombin topical (Recombinant) to include use in pediatric patients, following completion of a post-approval pediatric clinical trial commitment. RECOTHROM is a recombinant topical thrombin now indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adult and pediatric populations greater than or equal to one month of age. RECOTHROM provides patients greater than one month of age an alternative to bovine or human plasma derived thrombin.
"Pediatric patients, in various surgical settings, have an increased chance of repeat surgeries. RECOTHROM has been studied in pediatric patients and shown to have a low rate of immunogenicity, and offers an important tool for use in this patient population," said Kevin N. Foster, MD, MBA, FACS, Chief, Burn Services, The Arizona Burn Center at Maricopa Medical Center.
The recent FDA approval is based, in part, on data from a completed Phase 4, open-label, single-group safety and immunogenicity study. This study was conducted in 30 pediatric patients greater than one month of age undergoing synchronous burn wound excision and skin grafting. The safety of RECOTHROM in pediatric patients greater than or equal to one month of age is supported by these data and by extrapolation of efficacy from adequate and well-controlled studies of RECOTHROM in adults. Safety and efficacy has not been established in neonates.
"Our purpose is to save lives, alleviate suffering and improve the economic efficiency of the approximately 2,500 leading hospitals in the world," said Brent Furse, Senior Vice President and Chief Customer Officer of The Medicines Company. "There are several hundred leading hospitals in the United States that conduct thousands of surgical procedures in pediatric patients each year. We believe the expanded pediatric indication for RECOTHROM provides an opportunity to make this topical hemostat available to a broader range of surgical patients."
About The Medicines CompanyThe Medicines Company (NASDAQ : MDCO ) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well-being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com.
Wednesday, February 13, 2013
MDCO, Bristol-Myers Squibb begin global alliance for Recothrom
The global license and two-year collaboration signed between the Medicines Company (MDCO) and Bristol-Myers Squibb (BMS) for Recothrom, a recombinant thrombin approved by the US Food and Drug Administration (FDA) for use as a topical hemostat to control non-arterial bleeding during surgical procedures has become effective.
The agreement was first announced in December 2012. The companies have satisfied all required regulatory and closing conditions. Glenn Sblendorio, president and chief financial officer of The Medicines Company, said, "We look forward to the start of our global license and collaboration for Recothrom. We believe that completing this deal is another step to establish The Medicines Company as a leader in acute and intensive care medicine globally." Recothrom is a surgical hemostat that is applied topically to stop bleeding during surgery. Its active ingredient is recombinant human thrombin (rThrombin) and the product is indicated as an aid to hemostasis whenever control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. Recothrom is part of a class of surgical hemostats commonly referred to as "active" hemostats. Other classes of surgical hemostats include mechanical hemostats, flowable hemostats and fibrin sealants. Recothrom was approved in the United States in January 2008 and in Canada in December 2010. The Medicines Company provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. |
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recombinant,
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thrombin
Sunday, December 16, 2012
The Medicines Company and Bristol-Myers Squibb Agree to Global Alliance For Recothrom
The Medicines Company builds on portfolio and capabilities in acute and intensive care hospital medicine with marketed perioperative biologic
Parsippany, NJ, and Princeton, NJ, USA I December 12, 2012 I The Medicines Company (NASDAQ:MDCO) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the companies have signed a global license and two year collaboration for Recothrom®, a recombinant thrombin approved by the U.S. Food and Drug Administration for use as a topical hemostat to control non-arterial bleeding during surgical procedures.
Clive Meanwell, M.D., Ph.D., Chairman and CEO of The Medicines Company said, “As a marketed, growing product to control blood loss in the hospital, we believe Recothrom is a strategic fit that enables operating leverage with The Medicines Company’s emerging perioperative care portfolio. The financial structures and net revenues fit well with our strategy for aggressive and sustainable growth in acute and intensive care medicine. Of course, thrombin is also a hemodynamic target we know well based on our experience with Angiomax® (bivalirudin), a thrombin inhibitor.”
“The Medicines Company’s expertise in advancing the treatment of critical care patients in hospital settings worldwide makes it the natural partner to bring Recothrom to patients and physicians,” said Giovanni Caforio, President, U.S. Pharmaceuticals of Bristol-Myers Squibb. “This agreement is part of Bristol-Myers Squibb’s ongoing efforts to simplify operations, improve our efficiency and better position ourselves to focus on our important work in areas of significant unmet medical need that are critical to our long-term success."
Recothrom net revenues in 2011 were $65 million. The product is currently commercially available in the United States and Canada. The intellectual property license agreement is global and The Medicines Company anticipates pursuing approvals in additional countries.
The transaction is expected to be accretive to earnings per share (EPS) for The Medicines Company in 2013.
Under terms of the agreement, The Medicines Company will pay Bristol-Myers Squibb an upfront collaboration payment of $105 million and an upfront option fee of $10 million. The Medicines Company has also agreed to pay Bristol-Myers Squibb a tiered royalty on annual net revenues of Recothrom during the two-year collaboration term. Bristol-Myers Squibb will retain responsibility for the manufacturing of Recothrom and will be The Medicine Company’s exclusive supplier of Recothrom during the term of the agreement. The option enables The Medicines Company to acquire the Recothrom assets for a purchase price based on average net sales during the two-year collaboration term.
The transaction is expected to be minimally accretive to EPS for Bristol-Myers Squibb in 2013 and 2014.
The transaction is subject to the satisfaction or waiver of closing conditions, including the expiration or termination of applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the delivery by Bristol-Myers Squibb of certain audited financial information relating to the business.
Labels:
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recothrom,
thrombin,
Zymogenetics
Tuesday, September 18, 2012
Childhood Coagulation Marker Levels Distinct From Adulthood
Levels of key coagulation markers significantly vary with age in children, research reveals, potentially affecting the diagnosis and treatment of pediatric thrombotic and hemorrhagic disease.
Young children have significantly lower levels of fibrinogen and factor (F)II, IX, XI, and XII than older children, the researchers report in the Journal of Thrombosis and Haemostasis.
Younger age was also associated with significantly lower levels of Protein C and Protein S, but higher concentrations of D-dimer.
Von Willebrand factor (vWF) levels were also elevated in the first year of life, but there was no associated increase in FVIII levels, expected due to the known impact of vWF on FVIII half life.
vWF levels fell to a nadir at 1 year and then gradually increased to adult levels, but this trend was dependent on blood group type. Blood group O carriers showed only a slight increase from a median of 66% to 88% of adult levels, versus a median 106% in non-O blood group carriers.
The researchers believe this may be due to the increased susceptibility of vWF of blood group O to the proteolytic activity ofADAMTS13 compared with non-O blood groups. In the first months of childhood, when A, B, and H antigens of vWF are low, there may be less pronounced blood group differences in vWF levels.
"Our results underline the need for age-specific reference ranges," write Inge Appel and co-workers, from Erasmus Medical Centre - Sophia Children's Hospital in Rotterdam, the Netherlands.
The greatest variation was between infants in the first year of life versus adults, but inter-individual variability in coagulation factors was highest in the youngest children. The researchers therefore recommend: "In neonates and infants multiple reference samples are required to define the normal range in coagulation proteins for age more precisely."
The team examined blood samples from 218 healthy children aged 1-6 months (n=29), 7-12 months (n=25), 1-5 years (n=57), 6-10 years (n=57), 11-18 years (n=50), and over 19 years (n=52) using two different analyzers; the Behring Coagulation System (Siemens Healthcare Diagnostics Products GmbH, Marburg, Germany) and the CA-1500 system (Sysmex, Kobe, Japan).
There was good correlation between the two systems for all coagulation markers, except prothrombin and activated partial thromboplastin time.
Young children have significantly lower levels of fibrinogen and factor (F)II, IX, XI, and XII than older children, the researchers report in the Journal of Thrombosis and Haemostasis.
Younger age was also associated with significantly lower levels of Protein C and Protein S, but higher concentrations of D-dimer.
Von Willebrand factor (vWF) levels were also elevated in the first year of life, but there was no associated increase in FVIII levels, expected due to the known impact of vWF on FVIII half life.
vWF levels fell to a nadir at 1 year and then gradually increased to adult levels, but this trend was dependent on blood group type. Blood group O carriers showed only a slight increase from a median of 66% to 88% of adult levels, versus a median 106% in non-O blood group carriers.
The researchers believe this may be due to the increased susceptibility of vWF of blood group O to the proteolytic activity ofADAMTS13 compared with non-O blood groups. In the first months of childhood, when A, B, and H antigens of vWF are low, there may be less pronounced blood group differences in vWF levels.
"Our results underline the need for age-specific reference ranges," write Inge Appel and co-workers, from Erasmus Medical Centre - Sophia Children's Hospital in Rotterdam, the Netherlands.
The greatest variation was between infants in the first year of life versus adults, but inter-individual variability in coagulation factors was highest in the youngest children. The researchers therefore recommend: "In neonates and infants multiple reference samples are required to define the normal range in coagulation proteins for age more precisely."
The team examined blood samples from 218 healthy children aged 1-6 months (n=29), 7-12 months (n=25), 1-5 years (n=57), 6-10 years (n=57), 11-18 years (n=50), and over 19 years (n=52) using two different analyzers; the Behring Coagulation System (Siemens Healthcare Diagnostics Products GmbH, Marburg, Germany) and the CA-1500 system (Sysmex, Kobe, Japan).
There was good correlation between the two systems for all coagulation markers, except prothrombin and activated partial thromboplastin time.
Labels:
Clinical Papers,
fibrinogen,
thrombin
Friday, June 8, 2012
Study with Fibrocaps(TM) Lead product on track for market launch in 2014
LEIDEN, The Netherlands & SEATTLE, Jun 06, 2012 (BUSINESS WIRE) -- ProFibrix B.V., a leader in the development of innovative bioactive products to stop bleeding (hemostasis), today announced the start of its pivotal Phase III clinical trial with Fibrocaps (FINISH-3) in spine, liver, vascular and soft tissue surgery.
FINISH-3 is a multicenter, randomized, single-blind, controlled Phase III trial of Fibrocaps in 672 surgical patients with mild to moderate surgical bleeding. The main objectives of the study are to demonstrate superior efficacy of Fibrocaps vs. gelatin sponge within each surgical indication, and to confirm the overall safety results from the Phase II Fibrocaps trials completed in 2011.
Dr. Paul Frohna, Chief Medical Officer of ProFibrix said: "We are very pleased to announce the randomization and treatment of the first patients in the international FINISH-3 trial less than 4 months after completing our End-of-Phase II meeting with the U.S. FDA. Based on the excellent Phase II study results, the investigators are very eager to enroll their patients into our study and we remain on track for regulatory filings in the U.S. and EU in 2013. Based on the product's unique properties, and the overwhelmingly positive feedback we are receiving from the surgical community, we believe Fibrocaps should be able to capture a substantial share of the US$ 1 billion topical hemostat market."
The Fibrocaps used in the pivotal Phase III clinical trial has been manufactured by ProFibrix's commercial manufacturing partner Nova Laboratories Limited (Leicester, UK). Peter White, Managing Director of Nova Laboratories said: "It is great to be part of this exciting project and to manufacture the Phase III product and I am looking forward to our long term collaboration."
About Fibrocaps
Fibrocaps is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, and is stable at room temperature.
About the FINISH-3 trial
FINISH-3 is a prospective, randomized (2:1), single-blind, controlled, pivotal Phase III trial of Fibrocaps vs. active control in 672 subjects undergoing spinal (n=168), liver (n=168), vascular (n=168) and soft tissue surgery (n=168). The study will be conducted at 65 sites across Europe and the U.S. Estimated completion date is May 2013.
For more details on the study, please go to http://www.clinicaltrials.gov .
About ProFibrix
ProFibrix ( www.profibrix.com ) was founded in 2004 and is headquartered in Leiden, The Netherlands, with a subsidiary in Seattle, WA, USA. The company leverages its expertise in fibrinogen technology to develop and bring to market innovative products for the hemostasis and regenerative medicine markets. Human fibrinogen plays a pivotal role in blood clotting and tissue healing. ProFibrix is led by a team with extensive commercial, clinical and scientific experience in the hemostasis field.
SOURCE: ProFibrix
Labels:
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fibrocaps,
ProFibrix,
thrombin
Sunday, February 12, 2012
Revealed - UK NHS tests for Transfusion related vCJD. US California new cases.
In More Bad news for purveyors of Bovine derived products and transfusion supporters, thousands of NHS patients could be secretly monitored by the Government for symptoms of the human form of mad cow disease amid concerns that there could be another wave of infections.
Experts advising the Department of Health believe patients who have received more than 80 blood transfusions are most at risk of developing the fatal brain disease because it can be passed on through infected blood.
They say monitoring these patients could give vital clues about the way the disease develops and is transmitted from person to person and could help work out whether there are likely to be further deaths.

Thousands of NHS patients could be secretly monitored by the Government for symptoms of the human form of mad cow disease amid concerns that there could be another wave of infections
It could also inform officials whether the risk from blood donations needs to be treated more seriously.
But they are considering conducting their surveillance secretly because they fear that informing patients they are at risk and are being monitored will cause unnecessary alarm.
The proposals have been discussed by a powerful panel of leading scientists and doctors, which advises the Government on the disease, known as variant CJD.
More...
The panel's report, published online, suggests conducting 'covert health surveillance' of around 30,000 patients known to have received a high number of blood transfusions.
Experts would expect to see at least 150 cases of vCJD in this group of patients, based on scientific evidence that between one in 4,000 and one in 20,000 of the population may be infected.

Experts believe patients who have received more than 80 blood transfusions are most at risk of developing the fatal brain disease as it can be passed on through infected blood
But this has so far not been seen and may either mean the risk is lower than previously thought, or that it is taking longer for cases to develop.
The 'highly transfused' group includes people suffering life-threatening illnesses including acute leukaemia, aplastic anaemia and the blood disorder thalassemia - as well as those with multiple injuries due to road accidents, or heavy blood loss from aneurysms.
The report acknowledges that following patients without their consent is 'ethically problematic'.
But the panel, a subcommittee of the Advisory Committee on Dangerous Pathogens, has asked the Health Protection Agency to set out the various options for monitoring these patients based on seeking their consent or not.
Chris James, chief executive of the Haemophilia Society, said: 'We are shocked to learn there was ever any suggestion of non-consensual monitoring.
'Given the history of contaminated blood in the 1970s and 1980s, the maintenance of medical ethics is especially important to the haemophilia community.
'Any proposed framework must be reviewed by an ethics committee and open to challenge from individuals and organisations such as ourselves through a formal consultation process.'
Latest official figures show seven NHS patients have died from vCJD after having blood transfusions.
Four are known to have been given blood from people who were infected with fatal vCJD, and the other three had previously had transfusions although it is not known whether the blood was contaminated.
Since the first vCJD cases emerged in the mid-1990s, 175 people in Britain have died from the brain wasting disease, which is linked to eating beef infected with BSE.
Experts predicted that hundreds more could die after receiving blood infected with the disease. But they now admit they are baffled as to why these cases have failed to emerge.
One theory is that some people have a genetic advantage and may only carry the disease without developing symptoms. However, they can still infect others if they give blood.
In one case, a patient is known to have been exposed to vCJD in a blood transfusion and is still alive 24 years later.

A memorial plaque to victims of Human BSE on the Riverside Walk near Westminster Bridge, London
At the moment, patients are only informed that they are at increased risk of developing vCJD if they have been exposed to blood from more than 80 donors and if they are about to have brain, spinal or complex eye surgery.
But this threshold may now be raised to only inform patients if they are exposed to 300 or more blood donors because the lack of vCJD cases so far may indicate that the risk of catching vCJD in blood may be lower than previously suspected.
Judy Kenny, of the CJD Support Network, whose husband Deryck died aged 69 in 2003 after being given contaminated blood, said: 'If the authorities are going to do any monitoring, patients should be aware of it.
'There is no grey area - if they are thinking about unconsented monitoring, then it is wrong.'

CJD occurs when nerve-tissue proteins called prions (illustration above) turn 'bad' and gradually destroy the brain
Professor Chris Bunce, science director of charity Leukaemia and Lymphoma Research, said: 'The extent of the risk [of vCJD] to patients who receive regular blood transfusions as part of their treatment is as yet uncertain.
'One way to ascertain the risk would be to monitor the distribution of the pathogen among people in this group.
'But with that comes the moral question of whether patients should be informed or not, and this is the dilemma of the Health Protection Agency.'
A Department of Health spokesman said: 'No decisions have been taken on any unconsented follow-up of highly transfused patients.
'No unconsented follow-up has taken place and none would without appropriate ethical approval and on the basis of legal advice.
Meanwhile Stateside...
(Sacramento, CA)
Friday, February 10, 2012
Meanwhile Stateside...
(Sacramento, CA)
Friday, February 10, 2012
The Marin County Public Health Officer, Dr. Craig Lindquist, says one person who was diagnosed with a brain disorder similar to Mad Cow Disease has passed away, but that the person did not contract the disease from contaminated beef. That makes it the classic form of the disease and not the varient form.
There is another resident still living with Creutzfeldt Jacob Disease or CJD. Lindquist says there is no evidence it is of the varient variety either.
CJD is very rare, but always fatal. It attacks the memory, hand eye coordination and vision before killing the victim within a year.
The Mad Cow variant of the disease can be spread only by contact with the brain tissue or nervous system tissue of someone or something that is afflicted. Twenty five years ago, nearly 170 people died of the variant form of the disease in Europe.
Doctor Richard Breitmeyer runs the lab at UC Davis that tests Mad Cow disease in sheep and cattle.
BREITMEYER: "The current science believes in the United Kingdom that was the cause of Varient CJD in people in that they had consumed meat products that were contaminated with the bovine form."
Breitmeyer's lab is one of six in the nation.
Cattle fed with bovine bone meal was found to be a significant cause of the spread of the disease in Europe. Of the 40,000 animals tested each year in the United States since, only two tested positive.
In humans, 85 percent of those afflicted with classic CJD had no known risk factors. Five to ten percent had a genetic history of the disease.
Labels:
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CJD,
Cryolife,
King Pharmaceuticals,
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thrombin
Sunday, November 20, 2011
ProFibrix Phase II with FibrocapsTM Meets Primary Endpoint – On Track for Phase III in 2012
LEIDEN, The Netherlands & SEATTLE--(BUSINESS WIRE)-- ProFibrix B.V., a leader in the development of innovative products for hemostasis, today announced that its multicenter Phase II clinical trial with Fibrocaps in liver resection surgery resulted in a highly statistically significant 50% reduction in mean time to hemostasis (TTH) compared to active control.
A total of 56 patients were enrolled in the company’s Dutch prospective, randomized, controlled, multi-center Phase II study with lead product Fibrocaps for mild to moderate surgical bleeding. The study results show that Fibrocaps has a very good safety profile along with rapid hemostatic activity that succeeds in significantly reducing mean time to hemostasis, the primary end point of the Phase II trial.
Professor dr. R.J. Porte from the University Medical Center Groningen, the Lead Investigator of the study, said: “We’re very pleased with the excellent performance of Fibrocaps in this Phase II study. I have no doubt that the substantial reduction in mean time to hemostasis we report for Fibrocaps is clinically very meaningful, and demonstrates the strength of this unique dry powder formulation of fibrinogen and thrombin.”
Jan Öhrström, CEO of ProFibrix said: “Our clinical data constitute the strongest result ever reported for fibrin sealants in a Phase II study in this indication. These positive results ensure that we remain on track to initiate a pivotal Phase III trial in H1 2012, and target a BLA filing in 2013. In the coming months we expect to report on the results of the Phase II trial we are running in parallel in the U.S. Altogether we believe that the positive outcome of the European and U.S studies should allow us to generate strong support from investors as we continue developing Fibrocaps and its line extensions.”
A total of 56 patients were enrolled in the company’s Dutch prospective, randomized, controlled, multi-center Phase II study with lead product Fibrocaps for mild to moderate surgical bleeding. The study results show that Fibrocaps has a very good safety profile along with rapid hemostatic activity that succeeds in significantly reducing mean time to hemostasis, the primary end point of the Phase II trial.
Professor dr. R.J. Porte from the University Medical Center Groningen, the Lead Investigator of the study, said: “We’re very pleased with the excellent performance of Fibrocaps in this Phase II study. I have no doubt that the substantial reduction in mean time to hemostasis we report for Fibrocaps is clinically very meaningful, and demonstrates the strength of this unique dry powder formulation of fibrinogen and thrombin.”
Jan Öhrström, CEO of ProFibrix said: “Our clinical data constitute the strongest result ever reported for fibrin sealants in a Phase II study in this indication. These positive results ensure that we remain on track to initiate a pivotal Phase III trial in H1 2012, and target a BLA filing in 2013. In the coming months we expect to report on the results of the Phase II trial we are running in parallel in the U.S. Altogether we believe that the positive outcome of the European and U.S studies should allow us to generate strong support from investors as we continue developing Fibrocaps and its line extensions.”
Labels:
fibrinogen,
fibrocaps,
ProFibrix,
recombinant,
thrombin
Tuesday, November 8, 2011
Vascular Solutions Q3 2011
Net sales of hemostat products (primarily consisting of the D-Stat Dry, D-Stat Flowable and D-Stat Radial products) were $5.7 million in the third quarter, a decrease of 6% from the third quarter of 2010 and a decrease of 4% from the second quarter of 2011. "The hemostatic patch market has become even more price competitive. At the very end of the second quarter we launched our new Silver versions of the D-Stat Dry and Thrombix(R) products, which add an antimicrobial ingredient to the patches while leaving our pricing unchanged. We continue to expect these Silver versions to allow us to at least maintain our market-leading position in the hemostat patch market into 2012," Mr. Root said.
As previously disclosed, King Pharmaceuticals, Inc. notified Vascular Solutions on July 6, 2011, that it was electing to not proceed further with efforts to obtain a surgical use indication from the FDA for the company's Thrombi-Gel products and to not complete development of the company's Thrombi-Paste products. As a result, Vascular Solutions recognized an additional $2.6 million of license revenue during the third quarter of 2011 as the remaining deferred license revenue originally allocated to the Thrombi-Paste products and the surgical use indication of the Thrombi-Gel products as part of the agreements entered into with King in 2007. Starting in the fourth quarter of 2011, amortization of deferred revenue is expected to be $87,000 per quarter.
Hemostat Products: It appears that revenues will continue to be flat or declining in Vascular Solution’s hemostat product lines. Management cited competitive pricing pressure for Vascular Solution’s D-Stat Dry product. However, the company could see upside if Marine Polymer’s injunction against competitor HemCon is enforced. Marine Polymer was awarded an injunction in September but Hemcon was subsequently given a stay. The injunction would prevent HemCon from selling such products as the HemCon Bandage and the Chitoflex and Dental Dressings. Vascular Solutions management did say that launches of Silver versions of the D-Stat Dry and Thrombix products, which include a new antimicrobial ingredient, would enable the company to maintain hemostat market share.
Hemostat Products: It appears that revenues will continue to be flat or declining in Vascular Solution’s hemostat product lines. Management cited competitive pricing pressure for Vascular Solution’s D-Stat Dry product. However, the company could see upside if Marine Polymer’s injunction against competitor HemCon is enforced. Marine Polymer was awarded an injunction in September but Hemcon was subsequently given a stay. The injunction would prevent HemCon from selling such products as the HemCon Bandage and the Chitoflex and Dental Dressings. Vascular Solutions management did say that launches of Silver versions of the D-Stat Dry and Thrombix products, which include a new antimicrobial ingredient, would enable the company to maintain hemostat market share.
Labels:
D-Stat,
King Pharmaceuticals,
thrombin,
Vascular Solutions
Sunday, May 15, 2011
Public Increasingly Aware of Meat-Glue in Food - Health Industry Use Certain to be Debated?
As public awareness increases of the use of meat glue (animal derived thrombin) within the food industry, it seems inevitable that the use of similar products in surgery will become a discussion point. Particularly when perfectly viable alternatives are available, it will certainly impact the healthcare sector. Below is an excerpt of a commentary on this practice with further links below. We in the industry are fully aware of the risks associated with bovine thrombin... and this
Not to mention the public belief in regulatory protection
"There was...crap in that stuff. This stuff was manky, it was filthy, it was dirty ... but they still stuck it in the arms of children"
Meat what are you getting now?
The commercial meat packing industry and restaurants around the U.S. have found a new way to increase profits by using meat scraps to make filet mignons as well as hot dogs, sausages and stew meat. Powdered meat glue binds scraps of beef, lamb, chicken or fish, that would normally be thrown out, into solid pieces of meat. According to its manufacturer, meat glue can be used to produce new kinds of mixed meats (for example combining beef and fish seamlessly).
Meat glue permits restaurants and butchers to sell their meat scraps as premium meat. Once you cook the glued meat, even a professional butcher or chef can’t tell the difference.
This Franken-food is sold as imitation crabmeat, ham, hot dogs, sausage, fish balls, for making milk, making noodles firmer and making yogurt (water loss) creamier. It is also used for more expensive products such as filet mignons and veal steaks and products labeled as beef steak, chopped meat, shaped meat, frozen meat, pork or chicken as well as minute steak, formed meat, wafer sliced meat, frozen meat, beef added products, chopped meat, molded meat, cubed or frozen beef, chicken and pork as well as some Hydrolyzed plant protein.
So how do they glue meat together and make it look just like filet mignons? Super glue? No! A new miracle glue from 3M? No! The industry uses a pseudo-coagulant called Thrombin or Fibrimex, which were initially banned in Europe but now sold in the EU, Australia, Canada and the U.S.
Thrombin is sold under the brand names Activa RM and Fibrimex. The products derive from pig or bovine blood. The active ingredient is called transglutaminase. When sold in a store, products containing transglutaminase are labeled as “composite meat product”. However there are no labeling or disclosure requirements placed on restaurants.
But meat glue sold as Thrombin and transglutaminase have a different enzyme makeup. Transglutaminase is the enzyme that cross-links proteins in “meat glues.” Thrombin is a different protein, a protease that causes increased transglutaminase activity. Thrombin can be hazardous to use because if it enters a cut it can cause extensive blood clotting.
Thrombin contains Maltodextrin and sodium caseinate which contain (without disclosure) Ajinomoto’s MSG. Blood carries bacterias, toxins and viruses causing infections and autoimmune responses in animals as they do in humans.
Factory farms also use growth hormones (steroids) that require daily doses of antibiotics in an effort to control or minimize illnesses. Animal feed used in CAFOs contains pesticide residues that also contribute to illness. The use of antibiotics signals an admission that factory farmed animals are sick or become sick. Why would you give daily doses of antibiotics to an animal or human being unless they were sick?
The infectious agent that leads to mad cow disease can also be passed through animal blood meal. As a result of mad cow’s disease cases in 2004, the Bush administration’s FDA said it “would ban animal blood in cattle feed, while dietary supplements and cosmetics would be kept free of materials from cattle too sick or hurt to walk.” Consumer groups said the protections did not go far enough. Why does the food industry and the USDA think animal blood meal is now safe for human consumption? What has changed since 2004?
The commercial meat packing industry and restaurants around the U.S. have found a new way to increase profits by using meat scraps to make filet mignons as well as hot dogs, sausages and stew meat. Powdered meat glue binds scraps of beef, lamb, chicken or fish, that would normally be thrown out, into solid pieces of meat. According to its manufacturer, meat glue can be used to produce new kinds of mixed meats (for example combining beef and fish seamlessly).
Meat glue permits restaurants and butchers to sell their meat scraps as premium meat. Once you cook the glued meat, even a professional butcher or chef can’t tell the difference.
This Franken-food is sold as imitation crabmeat, ham, hot dogs, sausage, fish balls, for making milk, making noodles firmer and making yogurt (water loss) creamier. It is also used for more expensive products such as filet mignons and veal steaks and products labeled as beef steak, chopped meat, shaped meat, frozen meat, pork or chicken as well as minute steak, formed meat, wafer sliced meat, frozen meat, beef added products, chopped meat, molded meat, cubed or frozen beef, chicken and pork as well as some Hydrolyzed plant protein.
So how do they glue meat together and make it look just like filet mignons? Super glue? No! A new miracle glue from 3M? No! The industry uses a pseudo-coagulant called Thrombin or Fibrimex, which were initially banned in Europe but now sold in the EU, Australia, Canada and the U.S.
Thrombin is sold under the brand names Activa RM and Fibrimex. The products derive from pig or bovine blood. The active ingredient is called transglutaminase. When sold in a store, products containing transglutaminase are labeled as “composite meat product”. However there are no labeling or disclosure requirements placed on restaurants.
But meat glue sold as Thrombin and transglutaminase have a different enzyme makeup. Transglutaminase is the enzyme that cross-links proteins in “meat glues.” Thrombin is a different protein, a protease that causes increased transglutaminase activity. Thrombin can be hazardous to use because if it enters a cut it can cause extensive blood clotting.
Thrombin contains Maltodextrin and sodium caseinate which contain (without disclosure) Ajinomoto’s MSG. Blood carries bacterias, toxins and viruses causing infections and autoimmune responses in animals as they do in humans.
Factory farms also use growth hormones (steroids) that require daily doses of antibiotics in an effort to control or minimize illnesses. Animal feed used in CAFOs contains pesticide residues that also contribute to illness. The use of antibiotics signals an admission that factory farmed animals are sick or become sick. Why would you give daily doses of antibiotics to an animal or human being unless they were sick?
The infectious agent that leads to mad cow disease can also be passed through animal blood meal. As a result of mad cow’s disease cases in 2004, the Bush administration’s FDA said it “would ban animal blood in cattle feed, while dietary supplements and cosmetics would be kept free of materials from cattle too sick or hurt to walk.” Consumer groups said the protections did not go far enough. Why does the food industry and the USDA think animal blood meal is now safe for human consumption? What has changed since 2004?
Labels:
CJD,
infection,
mad cow disease,
thrombin
Tuesday, March 8, 2011
ProFibrix Initiates Phase II With Lead Hemostasis Product Fibrocaps(TM) in US and Europe
LEIDEN, The Netherlands and SEATTLE, March 8, 2011 /PRNewswire/ -- ProFibrix B.V., a leader in the development of innovative products for hemostasis, today announced that it has initiated a prospective, multi-center Phase II study with its lead product Fibrocaps at up to 20 sites, including major U.S. and Dutch academic medical centers.
Jaap Koopman, CEO of ProFibrix said: "The start of this large Phase II study in multiple surgical indications is a major milestone in the rapid development of our lead product Fibrocaps. If, as we expect, this study confirms the positive results of our first Phase II trial, we anticipate initiating a pivotal Phase III trial in early 2012, which puts us on track for a BLA filing early 2013."
About Fibrocaps
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, and is stable at room temperature.
About the Study
The second Phase II clinical trial of Fibrocaps (FC002) in the U.S. and Europe builds on the success of ProFibrix's first Phase II study at a number of European centers, which demonstrated a compelling safety and efficacy profile for Fibrocaps. The current Phase II trial is a prospective, randomized, single-blind, controlled study. The study sites include up to 20 major academic and leading private medical centers in the U.S. and Europe. Apart from measuring overall safety , the primary efficacy endpoint of the study is the mean time to hemostasis (TTH) of Fibrocaps versus control. Approximately 130 patients will be randomized across four different surgical indications: peripheral vascular surgery, spinal surgery, liver resection surgery and soft tissue dissection. Completion of the study is expected in the third quarter of 2011.
To allow ProFibrix to conduct the Fibrocaps Phase II clinical trial in the U.S., the company filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration. Following review by the Agency in December 2010, the IND is now open and ProFibrix has started enrolling patients at the participating centers in the U.S. and EU. For more details on the study, please go to http://www.clinicaltrials.gov.
Jaap Koopman, CEO of ProFibrix said: "The start of this large Phase II study in multiple surgical indications is a major milestone in the rapid development of our lead product Fibrocaps. If, as we expect, this study confirms the positive results of our first Phase II trial, we anticipate initiating a pivotal Phase III trial in early 2012, which puts us on track for a BLA filing early 2013."
About Fibrocaps
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, and is stable at room temperature.
About the Study
The second Phase II clinical trial of Fibrocaps (FC002) in the U.S. and Europe builds on the success of ProFibrix's first Phase II study at a number of European centers, which demonstrated a compelling safety and efficacy profile for Fibrocaps. The current Phase II trial is a prospective, randomized, single-blind, controlled study. The study sites include up to 20 major academic and leading private medical centers in the U.S. and Europe. Apart from measuring overall safety , the primary efficacy endpoint of the study is the mean time to hemostasis (TTH) of Fibrocaps versus control. Approximately 130 patients will be randomized across four different surgical indications: peripheral vascular surgery, spinal surgery, liver resection surgery and soft tissue dissection. Completion of the study is expected in the third quarter of 2011.
To allow ProFibrix to conduct the Fibrocaps Phase II clinical trial in the U.S., the company filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration. Following review by the Agency in December 2010, the IND is now open and ProFibrix has started enrolling patients at the participating centers in the U.S. and EU. For more details on the study, please go to http://www.clinicaltrials.gov.
Labels:
fibrinogen,
fibrocaps,
thrombin
Thursday, March 3, 2011
Nycomed sees 60% of sales in emerging markets by 2015
Nycomed has posted a 1.8% dip in turnover for 2010 to 3.17 billion euros, a reasonable result given the effects of generic competition to its gastrointestinal drug pantoprazole.
The Swiss privately-held drugmaker’s adjusted earnings before interest, taxes, depreciation and amortisation reached 850.5 million euros, down 20.9%. Pantoprazole sales fell 27.8% to 908.0 million euros, due principally to the loss of its patent in key European markets, Australia and Switzerland.
Sales of the drug in the USA, where it is sold as Protonix by partner Pfizer, are also falling as a result of 'at risk' launches by Teva and Sun in 2007; US exclusivity did not expire until last month. A lengthy legal battle is ongoing but recent judgments have sided with Nycomed which could pocket damages of up to $2 billion, some analysts have argued.
Much of Nycomed's future success is dependent on its recently-launched chronic obstructive pulmonary disease treatment Daxas (roflumilast). The drug, which hit the market in Denmark, Germany and the UK in September and is now available in several other European Union countries, brought in 3.8 million euros and earlier this week partner Forest Laboratories bagged US approval for the treatment, which will be sold as Daliresp.
Chief executive Hakan Bjorklund noted that a number of other products performed well, particularly from the bovine blood derivative Actovegin, the haemostatic agent TachoSil (fibrinogen/thrombin), the nasal spray Instanyl (fentanyl) for breakthrough cancer pain and Alvesco (ciclesonide) for asthma. He is particularly pleased with the Zurich-headquartered group's performance in emerging markets where it showed above industry average growth in 2010.
Mr Bjorklund noted that Russia/CIS is Nycomed's largest market and Brazil has moved into second. Emerging markets accounted for 39% of turnover in 2010 and by 2015, "we expect them to make up around 60% of our sales".
He concluded by saying that 2011 results will be impacted by "continuing strong marketing and sales efforts around launches of Daxas and focus on our operations in the emerging markets".
The Swiss privately-held drugmaker’s adjusted earnings before interest, taxes, depreciation and amortisation reached 850.5 million euros, down 20.9%. Pantoprazole sales fell 27.8% to 908.0 million euros, due principally to the loss of its patent in key European markets, Australia and Switzerland.
Sales of the drug in the USA, where it is sold as Protonix by partner Pfizer, are also falling as a result of 'at risk' launches by Teva and Sun in 2007; US exclusivity did not expire until last month. A lengthy legal battle is ongoing but recent judgments have sided with Nycomed which could pocket damages of up to $2 billion, some analysts have argued.
Much of Nycomed's future success is dependent on its recently-launched chronic obstructive pulmonary disease treatment Daxas (roflumilast). The drug, which hit the market in Denmark, Germany and the UK in September and is now available in several other European Union countries, brought in 3.8 million euros and earlier this week partner Forest Laboratories bagged US approval for the treatment, which will be sold as Daliresp.
Chief executive Hakan Bjorklund noted that a number of other products performed well, particularly from the bovine blood derivative Actovegin, the haemostatic agent TachoSil (fibrinogen/thrombin), the nasal spray Instanyl (fentanyl) for breakthrough cancer pain and Alvesco (ciclesonide) for asthma. He is particularly pleased with the Zurich-headquartered group's performance in emerging markets where it showed above industry average growth in 2010.
Mr Bjorklund noted that Russia/CIS is Nycomed's largest market and Brazil has moved into second. Emerging markets accounted for 39% of turnover in 2010 and by 2015, "we expect them to make up around 60% of our sales".
He concluded by saying that 2011 results will be impacted by "continuing strong marketing and sales efforts around launches of Daxas and focus on our operations in the emerging markets".
Labels:
fibrinogen,
Nycomed,
TachoSil,
thrombin
Tuesday, February 1, 2011
Pfizer acquisition of King Pharmaceuticals
It will likely be a few more weeks before King Pharmaceuticals employees learn how a pending acquisition by the world's largest drugmaker will affect their jobs.
Pfizer Inc. officials announced Monday the completion of a tender offer to purchase shares of the Bristol-based drug manufacturer and intentions to finish the acquisition by the end of February. Pfizer received federal antitrust approval to proceed with the $3.6 billion deal late last week.
"At this point, it's too early to determine any [job] impacts," Pfizer spokeswoman Joan Campion said in a phone interview with the Bristol Herald Courier. "We don't fully own the company, but we're expecting that to close in the first quarter -- in the next month or so. It's just too early to determine."
King has 435 administrative and manufacturing employees at its 5th Street corporate headquarters and 2,600 companywide. In addition to the Twin City, King operates drug manufacturing facilities in Florida, Illinois, Michigan, Missouri and Wisconsin, a research and development center in North Carolina and a commercial operations center in New Jersey. It also manufactures animal health products at plants in five states and China.
Pfizer employs more than 110,000 worldwide.
"We will conduct an evaluation of our work force and our real-estate holdings and make decisions based on serving our customers best, while still remaining competitive," Campion said.
Bristol, Tenn., City Manager Jeff Broughton said city officials are also awaiting word on what the purchase will mean for the company and the city.
"We have no information as to what will happen with King's manufacturing and office facility," Broughton said. "We've been waiting to try and approach Pfizer and stress to them the importance of that facility in Bristol, but we've only had preliminary conversations because they haven't completed the purchase."
New York-based Pfizer said Monday that about 93 percent -- or 230.7 million -- of King's outstanding shares were validly tendered and not withdrawn prior to a Jan. 28 deadline. Pfizer had offered to purchase the shares for $14.25 each in cash.
After agreeing to buy King in October, Pfizer extended its tender offer twice before last week's deadline.
For its money, Pfizer will acquire a group of branded prescription pharmaceuticals, including neuroscience products Skelaxin, Flector Patch, Avinza and painkiller Embeda; hospital products, including Thrombin-JMI; the EpiPen auto injector devices and nerve gas antidotes; and Remoxyl, an oxycodone capsule designed to be tamper-resistant that is awaiting approval from the Food and Drug Administration.
Pfizer, which is reporting its quarterly results today, said it will complete the deal through a short-form merger without a vote from remaining King shareholders.
In November, a number of King shareholders filed a series of class-action lawsuits attempting to block the merger. Each claims King's board of directors undervalued the company when it agreed to Pfizer's proposed purchase price and violated a fiduciary duty to make sure the company's shareholders got the best price for their stock.
Once the merger is completed, King's common stock will cease to be traded.
After announcing the tender, a share of Pfizer stock rose 7 cents on the New York Stock Exchange Monday, closing at $18.22. King's stock rose 2 cents and closed at $14.24.
Pfizer Inc. officials announced Monday the completion of a tender offer to purchase shares of the Bristol-based drug manufacturer and intentions to finish the acquisition by the end of February. Pfizer received federal antitrust approval to proceed with the $3.6 billion deal late last week.
"At this point, it's too early to determine any [job] impacts," Pfizer spokeswoman Joan Campion said in a phone interview with the Bristol Herald Courier. "We don't fully own the company, but we're expecting that to close in the first quarter -- in the next month or so. It's just too early to determine."
King has 435 administrative and manufacturing employees at its 5th Street corporate headquarters and 2,600 companywide. In addition to the Twin City, King operates drug manufacturing facilities in Florida, Illinois, Michigan, Missouri and Wisconsin, a research and development center in North Carolina and a commercial operations center in New Jersey. It also manufactures animal health products at plants in five states and China.
Pfizer employs more than 110,000 worldwide.
"We will conduct an evaluation of our work force and our real-estate holdings and make decisions based on serving our customers best, while still remaining competitive," Campion said.
Bristol, Tenn., City Manager Jeff Broughton said city officials are also awaiting word on what the purchase will mean for the company and the city.
"We have no information as to what will happen with King's manufacturing and office facility," Broughton said. "We've been waiting to try and approach Pfizer and stress to them the importance of that facility in Bristol, but we've only had preliminary conversations because they haven't completed the purchase."
New York-based Pfizer said Monday that about 93 percent -- or 230.7 million -- of King's outstanding shares were validly tendered and not withdrawn prior to a Jan. 28 deadline. Pfizer had offered to purchase the shares for $14.25 each in cash.
After agreeing to buy King in October, Pfizer extended its tender offer twice before last week's deadline.
For its money, Pfizer will acquire a group of branded prescription pharmaceuticals, including neuroscience products Skelaxin, Flector Patch, Avinza and painkiller Embeda; hospital products, including Thrombin-JMI; the EpiPen auto injector devices and nerve gas antidotes; and Remoxyl, an oxycodone capsule designed to be tamper-resistant that is awaiting approval from the Food and Drug Administration.
Pfizer, which is reporting its quarterly results today, said it will complete the deal through a short-form merger without a vote from remaining King shareholders.
In November, a number of King shareholders filed a series of class-action lawsuits attempting to block the merger. Each claims King's board of directors undervalued the company when it agreed to Pfizer's proposed purchase price and violated a fiduciary duty to make sure the company's shareholders got the best price for their stock.
Once the merger is completed, King's common stock will cease to be traded.
After announcing the tender, a share of Pfizer stock rose 7 cents on the New York Stock Exchange Monday, closing at $18.22. King's stock rose 2 cents and closed at $14.24.
Labels:
King Pharmaceuticals,
thrombin
Monday, January 24, 2011
Exhibit Caution with Bovine Thrombin
Wednesday, December 15, 2010
Blood disease attacks body’s ability to stop bleeding
A 16-year-old Paducah boy and a 72-year-old Hickory woman share a condition that could leave them unable to stop bleeding from a major wound.
Dr. Danny Butler of Paducah said Derek Willett and Phyllis Dublin suffer from idiopathic thrombocytopenic purpora. He described the disease as an assault by the body’s own immune system on blood platelets. Platelets are the component of the blood that gather at wound sites and form blood clots, stopping the body from bleeding to death. Different from hemophilia, the body suffers only from sudden acute drops in platelet levels, not in clotting factor.
“Common side effects are bruising, nosebleeds, a black spot in the mouth and bleeding into the gums,” Butler said. “We usually diagnose with a platelet count.”
Butler said the cause of the disease is unknown. Some patients, like Dublin, experience severe bleeding. Dublin bled into her lungs, which could have caused her to drown. The condition is treated by suppressing the entire immune system through anti-inflammatory steroids such as prednisone. Once treated, Dublin’s lungs re-absorbed the blood.
“We don’t know why some people choose to bleed from a certain location.” Butler said. “It could be life-threatening. We have to always look at the platelet levels. If it’s low, we would not like to operate and have to treat.”
If blood platelet levels are low or a patient has suffered severe bleeding, a blood transfusion remains an option. Butler warned that even with a transfusion, the body’s immune system could attack blood platelets. In severe cases, surgeons could remove a patient’s spleen. The spleen removes blood platelets attacked by antibodies.
“It’s a little more common in women than men and people 65 or older,” Butler said. “A lot can trigger the immune system. For every organ, we’re finding auto-immune disorders. We have a lot of work to do.”
Willett said his physician discovered the disease in a routine blood screening in 2009. The junior at St. Mary High School in Paducah said he was undergoing a physical for cross-country running when doctors noted his low platelet count. He’s reported no major episodes of bleeding, but monitors his platelet count closely.
“Doctors say I should avoid head and other serious trauma, but I’m not on steroids at this point,” Willett said. “They won’t do that unless my platelet count falls below 20,000 because steroids affect other organs in a bad way.”
Willett said he has conducted several fundraisers for Vanderbilt University Medical Center to research ITP. He’s raised $600 with a bake sale, selling bracelets and with a donation jar. For now, he is mindful of potential risks and hopes he grows out of his condition.
Dublin said she’s had no major episodes since August, but blames ITP for periods of weakness and fatigue earlier in the year.
“It was difficult to breathe, no worse than that,” Dublin said. She said the difficulty hit her one day about 11 a.m. “By 12:30, I was in the ER fighting for my life,” Dublin said.
Dublin said she stopped at the Mayfield Fire Department for oxygen. An ambulance took her to Western Baptist Hospital for treatment.
“I haven’t had any problems since, and the doctor started me on 90 mg of prednisone,” Dublin said. “He moved me from 90 to 60 to 40 and 10. Now I take 5 mg every other day. The thing is, this can affect anyone at any age, and comes on with no warning.”
Willett told teens and people of all ages to have complete blood count exam to determine if platelet levels are low.
Friday, November 19, 2010
Ethicon Inc announces submission of BLA for Fibrin Pad
Ethicon Inc, a Johnson & Johnson (NYSE: JNJ) company, reported on Thursday the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for the Fibrin Pad to aid in stopping soft tissue bleeding during surgery.
The company's BLA submission includes efficacy and safety data from a randomised, controlled clinical study in which the Fibrin Pad was used as an adjunct to hemostasis in soft tissue bleeding. According to Ethicon the Fibrin Pad is a novel product candidate that combines two methods of action: biomaterials and plasma-derived biologics (Human Fibrinogen and Human Thrombin).The Fibrin Pad is intended for use by surgeons as an adjunct to hemostasis when surgical methods are ineffective or impractical to control bleeding.
Labels:
Ethicon,
fibrin,
fibrinogen,
J and J,
thrombin
ArterX™ Clinical Trial Results Announced at Veith Meeting
MOUNTAIN VIEW, Calif., Nov. 18, 2010 /PRNewswire/ -- US clinical trial results for Tenaxis' investigational vascular surgical sealant, ArterX, were presented today at the Veith Meeting in New York. William M. Stone, MD of the Mayo Clinic, Scottsdale AZ reported a more than 20% margin of improvement for ArterX Surgical Sealant in the sealing of vascular suture lines compared with a control group featuring a commercially available gelatin foam/thrombin combination.
In a presentation titled "A Novel More Effective Glue-Sealant (ArterX) for Hemostasis at Vascular Suture Lines and Other Sites," Dr. Stone reported that ArterX Surgical Sealant achieved immediate hemostasis more than 60% of the time in a 217 patient clinical trial conducted at 11 different hospitals in the US.
President and CEO, David Smith, commented, "We are delighted with the preliminary results of our US clinical trial. We were also able to show a statistically significant reduction in operating time of 36 minutes in the ArterX group, and ArterX patients were discharged from hospital after 4.1 days, an improvement of 1.3 days over the control group. If approved, we believe that ArterX Surgical Sealant will yield economic benefits for surgeons and hospitals that adopt it."
ArterX Surgical Sealant is currently under review by the FDA and is not available for sale in the USA.
ArterX is CE marked for the EU.
In a presentation titled "A Novel More Effective Glue-Sealant (ArterX) for Hemostasis at Vascular Suture Lines and Other Sites," Dr. Stone reported that ArterX Surgical Sealant achieved immediate hemostasis more than 60% of the time in a 217 patient clinical trial conducted at 11 different hospitals in the US.
President and CEO, David Smith, commented, "We are delighted with the preliminary results of our US clinical trial. We were also able to show a statistically significant reduction in operating time of 36 minutes in the ArterX group, and ArterX patients were discharged from hospital after 4.1 days, an improvement of 1.3 days over the control group. If approved, we believe that ArterX Surgical Sealant will yield economic benefits for surgeons and hospitals that adopt it."
ArterX Surgical Sealant is currently under review by the FDA and is not available for sale in the USA.
ArterX is CE marked for the EU.
Tuesday, November 9, 2010
X-ray crystallography reveals structure of precursor to blood-clotting protein
ST. LOUIS — Using state-of-the-art robotic and x-ray crystallographic equipment, researchers at Saint Louis University have revealed for the first time the molecular structure of the zymogen, or inactive, form of a blood-clotting enzyme.
In an article published in Proceedings of the National Academy of Sciences, Enrico Di Cera, M.D., chair of the department of biochemistry and molecular biology at Saint Louis University School of Medicine and lead researcher of the study, said the NIH-funded research offers important information about the protein.
“This research is very basic and very important,” said Di Cera. “It provides a missing link between the inactive zymogen form of thrombin and the mature enzyme generated upon vascular injury.”
Before thrombin becomes active, it circulates throughout the blood in the inactive zymogen form. When the active enzyme is needed, for example after a vascular injury, the coagulation cascade is initiated and the zymogen is converted into an active enzyme that causes blood to clot.
Blood clotting performs the important function of stopping blood loss after an injury. However, when triggered in the wrong conditions, clotting can lead to debilitating or fatal conditions like heart attack, stroke and deep vein thrombosis.
In previous laboratory research, Di Cera re-engineered thrombin to act as an anticoagulant, stopping blood from clotting and opening the door to the development of new therapeutic strategies for the treatment of thrombosis, the presence of blood clots in blood vessels, which is responsible for nearly a third of all deaths in the U.S.
While researchers have an understanding of the structure of active thrombin, very little was known about its zymogen form. In order to learn more, researchers used x-ray crystallography to gather data about the molecular structure of the protein.
The process involves growing a crystal of the protein, shooting x-ray beams through the crystal and analyzing the diffraction patterngenerated on a detector plate in order to detail the three-dimensional structure of the protein.
The structure of the zymogen form of thrombin provides crucial details about the activation mechanism that sheds light on the way the mature enzyme works. Future research can capitalize on these new findings to define better strategies for therapeutic intervention.
“Until now, we’ve known nothing about the zymogen form of thrombin or any blood-clotting enzyme,” said Di Cera. “All the structural information has been limited to the active form.
“We now know that the zymogen form of thrombin is very different from the mature enzyme, in ways that open new opportunities for therapeutic intervention.”
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.
In an article published in Proceedings of the National Academy of Sciences, Enrico Di Cera, M.D., chair of the department of biochemistry and molecular biology at Saint Louis University School of Medicine and lead researcher of the study, said the NIH-funded research offers important information about the protein.
“This research is very basic and very important,” said Di Cera. “It provides a missing link between the inactive zymogen form of thrombin and the mature enzyme generated upon vascular injury.”
Before thrombin becomes active, it circulates throughout the blood in the inactive zymogen form. When the active enzyme is needed, for example after a vascular injury, the coagulation cascade is initiated and the zymogen is converted into an active enzyme that causes blood to clot.
Blood clotting performs the important function of stopping blood loss after an injury. However, when triggered in the wrong conditions, clotting can lead to debilitating or fatal conditions like heart attack, stroke and deep vein thrombosis.
In previous laboratory research, Di Cera re-engineered thrombin to act as an anticoagulant, stopping blood from clotting and opening the door to the development of new therapeutic strategies for the treatment of thrombosis, the presence of blood clots in blood vessels, which is responsible for nearly a third of all deaths in the U.S.
While researchers have an understanding of the structure of active thrombin, very little was known about its zymogen form. In order to learn more, researchers used x-ray crystallography to gather data about the molecular structure of the protein.
The process involves growing a crystal of the protein, shooting x-ray beams through the crystal and analyzing the diffraction patterngenerated on a detector plate in order to detail the three-dimensional structure of the protein.
The structure of the zymogen form of thrombin provides crucial details about the activation mechanism that sheds light on the way the mature enzyme works. Future research can capitalize on these new findings to define better strategies for therapeutic intervention.
“Until now, we’ve known nothing about the zymogen form of thrombin or any blood-clotting enzyme,” said Di Cera. “All the structural information has been limited to the active form.
“We now know that the zymogen form of thrombin is very different from the mature enzyme, in ways that open new opportunities for therapeutic intervention.”
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.
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