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.
Showing posts with label fibrinogen. Show all posts
Showing posts with label fibrinogen. Show all posts
Monday, August 5, 2013
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.
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
Sunday, November 20, 2011
ProFibrix Phase II with FibrocapsTM Meets Primary Endpoint – On Track for Phase III in 2012
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.”
Monday, October 3, 2011
Fibrinogen and Hemostasis: A Primary Hemostatic Target for the Management of Acquired Bleeding
Jerrold H. Levy, MD, FAHA,
Fania Szlam, MMSc,
Kenichi A. Tanaka, MDand
Roman M. Sniecienski, MD
+Author Affiliations
From the Department of Anesthesiology, Emory University School of Medicine, Cardiothoracic Anesthesiology and Critical Care, Emory Healthcare, Atlanta, Georgia.
Address correspondence to Jerrold H. Levy, MD, FAHA, Department of Anesthesiology, Emory University School of Medicine, Cardiothoracic Anesthesiology and Critical Care, Emory Healthcare, Atlanta, GA.
Abstract
Fibrinogen plays several key roles in the maintenance of hemostasis. Its cleavage by thrombin and subsequent polymerization to form fibrin strands provides the structural network required for effective clot formation. During cases of acute blood loss, attempts to maintain circulating volume and tissue perfusion often involve the infusion of crystalloids, colloids, and red blood cells. Intravascular volume resuscitation, although vital, frequently results in dilution of the remaining clotting factors and onset of dilutional coagulopathy. In such cases, fibrinogen is the first coagulation factor to decrease to critically low levels. There currently is a lack of awareness among physicians regarding the significance of fibrinogen during acute bleeding and, at many centers, fibrinogen is not monitored routinely during treatment. We reviewed current studies that demonstrate the importance of considering fibrinogen replacement during the treatment of acquired bleeding across clinical settings. If depleted, the supplementation of fibrinogen is key for the rescue and maintenance of hemostatic function; however, the threshold at which such intervention should be triggered is currently poorly defined. Although traditionally performed via administration of fresh frozen plasma or cryoprecipitate, the use of lyophilized fibrinogen (concentrate) is becoming more prevalent in some countries. Recent reports relating to the efficacy of fibrinogen concentrate suggest that it is a viable alternative to traditional hemostatic approaches, which should be considered. The prospective study of fibrinogen supplementation in acquired bleeding is needed to accurately assess the range of clinical settings in which this management strategy is appropriate, the most effective method of supplementation and a comprehensive safety profile of fibrinogen concentrate used for such an approach.
Accepted July 11, 2011.
Fania Szlam, MMSc,
Kenichi A. Tanaka, MDand
Roman M. Sniecienski, MD
+Author Affiliations
From the Department of Anesthesiology, Emory University School of Medicine, Cardiothoracic Anesthesiology and Critical Care, Emory Healthcare, Atlanta, Georgia.
Address correspondence to Jerrold H. Levy, MD, FAHA, Department of Anesthesiology, Emory University School of Medicine, Cardiothoracic Anesthesiology and Critical Care, Emory Healthcare, Atlanta, GA.
Abstract
Fibrinogen plays several key roles in the maintenance of hemostasis. Its cleavage by thrombin and subsequent polymerization to form fibrin strands provides the structural network required for effective clot formation. During cases of acute blood loss, attempts to maintain circulating volume and tissue perfusion often involve the infusion of crystalloids, colloids, and red blood cells. Intravascular volume resuscitation, although vital, frequently results in dilution of the remaining clotting factors and onset of dilutional coagulopathy. In such cases, fibrinogen is the first coagulation factor to decrease to critically low levels. There currently is a lack of awareness among physicians regarding the significance of fibrinogen during acute bleeding and, at many centers, fibrinogen is not monitored routinely during treatment. We reviewed current studies that demonstrate the importance of considering fibrinogen replacement during the treatment of acquired bleeding across clinical settings. If depleted, the supplementation of fibrinogen is key for the rescue and maintenance of hemostatic function; however, the threshold at which such intervention should be triggered is currently poorly defined. Although traditionally performed via administration of fresh frozen plasma or cryoprecipitate, the use of lyophilized fibrinogen (concentrate) is becoming more prevalent in some countries. Recent reports relating to the efficacy of fibrinogen concentrate suggest that it is a viable alternative to traditional hemostatic approaches, which should be considered. The prospective study of fibrinogen supplementation in acquired bleeding is needed to accurately assess the range of clinical settings in which this management strategy is appropriate, the most effective method of supplementation and a comprehensive safety profile of fibrinogen concentrate used for such an approach.
Accepted July 11, 2011.
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.
Thursday, March 3, 2011
Nycomed sees 60% of sales in emerging markets by 2015
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".
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.
Sunday, November 7, 2010
Researchers invent inkjet that prints out living skin
This is no horror movie, this is part of a recent presentation at the American College of Surgeons Clinical Congress, where Wake Forest Institute for Regenerative Medicine researchers had a super fun time showing off their results from a printer that uses living cells instead of ink. Fluid based inkjet technology used in the very printers you’ve got in your home or office is used to lay down cells, printing large sections of living tissue down on cut up or damaged areas of the body. These fine folks from the Institute note that “any loss of full-thickness skin of more than 4 cm in diameter will not heal by itself,” and that with this device, (refined and tested extensively, of course,) skin that might have been otherwise damaged horrifically can now be patched up to a much higher level of healthiness. Testing has occurred on mice revealing advanced healing by the second and third week of recovery and complete closure of the skin by the end of week three on wounds that would otherwise still be open to infection.
The printer works with two heads, one that dispenses skin cells mixed with fibrinogen (a blood coagulant) and type I collagen (connective tissue’s main component in scars), the other which sends out thrombin (another coagulant.) Together these create a chemical reaction and form fibrin, another protein that works on the clotting of blood. On top of this is one more layer printed by the printer: keratinocytes – the outer layer of skin we’ve all got right this moment.
Future research will be done on the pigs who, if you know your Gangs of New York lore, are great to practice stabbing on because they’ve got skin that very closely resembles human skin. Will this device ever hit your local wartime hospital or town hospital? Who can tell?
The printer works with two heads, one that dispenses skin cells mixed with fibrinogen (a blood coagulant) and type I collagen (connective tissue’s main component in scars), the other which sends out thrombin (another coagulant.) Together these create a chemical reaction and form fibrin, another protein that works on the clotting of blood. On top of this is one more layer printed by the printer: keratinocytes – the outer layer of skin we’ve all got right this moment.
Future research will be done on the pigs who, if you know your Gangs of New York lore, are great to practice stabbing on because they’ve got skin that very closely resembles human skin. Will this device ever hit your local wartime hospital or town hospital? Who can tell?
Thursday, June 17, 2010
ProFibrix and CSL Behring Enter Into Fibrinogen and Thrombin Supply Agreement
LEIDEN, The Netherlands and SEATTLE, June 17, 2010 /PRNewswire/ -- ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced that it has entered into an agreement with CSL Behring for the clinical and commercial supply of plasma-based fibrinogen and thrombin, for the manufacturing of Fibrocaps(TM). CSL Behring is a leader in the plasma protein therapeutics industry and a subsidiary of CSL Limited (ASX: CSL), a global biopharmaceutical company headquartered in Melbourne, Australia.
Jaap Koopman, CEO of ProFibrix said: "We are extremely pleased with the supply agreement with CSL Behring. CSL Behring is one of the acknowledged global leaders in the plasma protein therapeutic industry. Importantly, the agreement will enable us to use CSL Behring's fibrinogen and thrombin, approved in markets around the world, as active components in our lead product Fibrocaps. This will offer us a tremendous advantage with regulatory authorities when seeking approval for Fibrocaps."
About Fibrocaps
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant in development to stop bleeding after or during surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, is stable at room temperature, and has shown to be safe and efficacious in the first Phase II study conducted in EU. ProFibrix is starting a global Phase II study in the summer of 2010.
Jaap Koopman, CEO of ProFibrix said: "We are extremely pleased with the supply agreement with CSL Behring. CSL Behring is one of the acknowledged global leaders in the plasma protein therapeutic industry. Importantly, the agreement will enable us to use CSL Behring's fibrinogen and thrombin, approved in markets around the world, as active components in our lead product Fibrocaps. This will offer us a tremendous advantage with regulatory authorities when seeking approval for Fibrocaps."
About Fibrocaps
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant in development to stop bleeding after or during surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, is stable at room temperature, and has shown to be safe and efficacious in the first Phase II study conducted in EU. ProFibrix is starting a global Phase II study in the summer of 2010.
Thursday, June 3, 2010
J&J comment on EU market and the US release of Fibrin Pad
Johnson & Johnson's (JNJ) big medical devices and diagnostics unit anticipates that pressure on product prices in Europe will rise over the long term but not immediately, the unit's top official said Thursday.
J&J also said it expects the portion of the $350 billion devices and diagnostics market it competes in to grow at a faster rate than the overall market.
Additionally, the company anticipates that unit will make about 80 "significant" regulatory filings between 2010 and 2010.
J&J, which is dealing with fallout from the recent recall of children's medicines, is holding an all-day review Thursday for the devices and diagnostics unit. That unit grew sales by 2% to $23.6 billion last year and became J&J's largest segment, eclipsing a pharmaceutical business that has been pressured by competition from generic drugs.
The segment derived more than half of its sales last year from outside the U.S. A big question for device and drug companies these days is how the European debt crisis will affect product prices as governments try to rein in health spending.
"I think longer term we clearly see there being increased pricing pressure," Alex Gorsky, worldwide chairman for J&J's devices and diagnostics unit, said during the meeting. But there are reasons to believe it won't be an "immediate" issue, and doesn't mirror the situation with drug prices, he said.
These reasons include the tendering systems used to purchase devices and the dynamics between hospitals and governments, he said.
Pricing in Europe remained a top issue when analysts asked questions. Gorsky told them the pricing issue is difficult to forecast. He also said J&J hasn't seen a slowdown in procedure volumes that could also impact sales, but added "we'll have to watch closely."
Healthcare company Johnson & Johnson (JNJ), Thursday revealed growth strategies and product pipeline information for its Medical Devices & Diagnostics Segment. The company said the segment was its largest, and that new products and acquisitions would help sustain its market-leading position in the $350 billion, worldwide medical device and diagnostics market.
The New Brunswick, New Jersey-based company provided information on products that have been launched already or are on the anvil for the current fiscal, from its seven global franchises.
Ethicon Endo-Surgery, a maker of surgical device solutions for minimally invasive and open surgery; and Advanced Sterilization Products is rolling out a host of new products, J&J said. They include new energy instruments as part of its HARMONIC family of technology that delivers precise ultrasonic energy to minimize thermal tissue damage to the patient, while providing surgical efficiency.
Further, Ethicon continued to focus on patient comfort and surgeon ease-of-use as it built its portfolio of hernia repair products with ETHICON PHYSIOMESH Flexible Composite Mesh and its first entry into the hernia mesh fixation market with ETHICON SECURESTRAP 5mm Strap Fixation Device.
Ethicon Endo-Surgery would make a BLA filing in the U.S for its Fibrin Pad in the fourth quarter. The product combines two biomaterials and two biologics to stop bleeding during surgical procedures.
J&J also said it expects the portion of the $350 billion devices and diagnostics market it competes in to grow at a faster rate than the overall market.
Additionally, the company anticipates that unit will make about 80 "significant" regulatory filings between 2010 and 2010.
J&J, which is dealing with fallout from the recent recall of children's medicines, is holding an all-day review Thursday for the devices and diagnostics unit. That unit grew sales by 2% to $23.6 billion last year and became J&J's largest segment, eclipsing a pharmaceutical business that has been pressured by competition from generic drugs.
The segment derived more than half of its sales last year from outside the U.S. A big question for device and drug companies these days is how the European debt crisis will affect product prices as governments try to rein in health spending.
"I think longer term we clearly see there being increased pricing pressure," Alex Gorsky, worldwide chairman for J&J's devices and diagnostics unit, said during the meeting. But there are reasons to believe it won't be an "immediate" issue, and doesn't mirror the situation with drug prices, he said.
These reasons include the tendering systems used to purchase devices and the dynamics between hospitals and governments, he said.
Pricing in Europe remained a top issue when analysts asked questions. Gorsky told them the pricing issue is difficult to forecast. He also said J&J hasn't seen a slowdown in procedure volumes that could also impact sales, but added "we'll have to watch closely."
Healthcare company Johnson & Johnson (JNJ), Thursday revealed growth strategies and product pipeline information for its Medical Devices & Diagnostics Segment. The company said the segment was its largest, and that new products and acquisitions would help sustain its market-leading position in the $350 billion, worldwide medical device and diagnostics market.
The New Brunswick, New Jersey-based company provided information on products that have been launched already or are on the anvil for the current fiscal, from its seven global franchises.
Ethicon Endo-Surgery, a maker of surgical device solutions for minimally invasive and open surgery; and Advanced Sterilization Products is rolling out a host of new products, J&J said. They include new energy instruments as part of its HARMONIC family of technology that delivers precise ultrasonic energy to minimize thermal tissue damage to the patient, while providing surgical efficiency.
Further, Ethicon continued to focus on patient comfort and surgeon ease-of-use as it built its portfolio of hernia repair products with ETHICON PHYSIOMESH Flexible Composite Mesh and its first entry into the hernia mesh fixation market with ETHICON SECURESTRAP 5mm Strap Fixation Device.
Ethicon Endo-Surgery would make a BLA filing in the U.S for its Fibrin Pad in the fourth quarter. The product combines two biomaterials and two biologics to stop bleeding during surgical procedures.
Saturday, May 22, 2010
Hemostat Companies Persist With Animal Derived Production Despite Risks
Despite the World Health Organisation (WHO) recommending....."The pharmaceutical industry should ideally avoid the use of bovine materials and materials from other animal species in which TSEs naturally occur. If their use is absolutely necessary, bovine materials should be obtained from countries which have a surveillance system for BSE in place and which report either zero or only sporadic cases of BSE. These precautions apply to the manufacture of cosmetics as well."Some Medical Device companies are seeming to blithely plunge onward commercialising animal derived hemostatic products. There does seem adequate reason for concern for this along with other technologies from safer sources.
Interested in Human-Horse Diseases? ClickHERE and HERE
Researchers have found new evidence for the existence of a subclinical form of bovine spongiform encephalopathy (BSE). Cattle, sheep, and other animals that are outwardly healthy may be harbouring the infection, with the risk that BSE could still be getting into the food chain.
In a new study based on a mouse model, researchers at the Medical Research Council Prion Unit took a closer look at the species barrier, which limits the ability of prions to jump from one species to another (Proceedings of the National Academy of Sciences 2000;97:10248-53).
In the study, scientists tried to infect laboratory mice with hamster prions and saw no apparent signs of disease. But when they looked more closely they found that the mice had high levels of prion in their brains.
"Previously scientists have injected mice with the hamster disease, found no clinical signs of infection, and concluded it cannot jump the species barrier," said Dr Andrew Hill of the University of Melbourne, one of the authors of the study.
The team, led by Professor John Collinge, director of the MRC Prion Unit, also found that the new subinfection could be easily passed on when injected into healthy mice and hamsters.
"These results have a number of important implications. They suggest that we should rethink how we measure species barriers in the laboratory and that we should not assume that just because one species appears resistant to a strain of prions they have been exposed to, that they do not silently carry the infection," said Professor Collinge.
He continued: "These new findings have important implications for those researching prion disease, those responsible for preventing infected material getting into the food chain, and those considering how best to safeguard health and reduce the risk that, theoretically, prion disease could be contracted through medical and surgical procedures."
In a new study based on a mouse model, researchers at the Medical Research Council Prion Unit took a closer look at the species barrier, which limits the ability of prions to jump from one species to another (Proceedings of the National Academy of Sciences 2000;97:10248-53).
In the study, scientists tried to infect laboratory mice with hamster prions and saw no apparent signs of disease. But when they looked more closely they found that the mice had high levels of prion in their brains.
"Previously scientists have injected mice with the hamster disease, found no clinical signs of infection, and concluded it cannot jump the species barrier," said Dr Andrew Hill of the University of Melbourne, one of the authors of the study.
The team, led by Professor John Collinge, director of the MRC Prion Unit, also found that the new subinfection could be easily passed on when injected into healthy mice and hamsters.
"These results have a number of important implications. They suggest that we should rethink how we measure species barriers in the laboratory and that we should not assume that just because one species appears resistant to a strain of prions they have been exposed to, that they do not silently carry the infection," said Professor Collinge.
He continued: "These new findings have important implications for those researching prion disease, those responsible for preventing infected material getting into the food chain, and those considering how best to safeguard health and reduce the risk that, theoretically, prion disease could be contracted through medical and surgical procedures."
Countries or regions with a controlled BSE risk
EU Member States — Belgium, Bulgaria, the Czech Republic, Denmark, Germany, Estonia, Ireland, Greece, Spain, France, Italy, Cyprus, Latvia, Lithuania, Luxembourg, Hungary, Malta, the Netherlands, Austria, Poland, Portugal, Romania, Slovenia, Slovakia, the United Kingdom
EFTA countries — Switzerland, Liechtenstein
Third countries— Brazil, Canada, Chile, Taiwan, Mexico, United States
Tachosil - IFU and FDA info
Horse tendons for production of Collagen Sponge are collected from slaughterhouses. ---(b)(4)-- (horse–(b)(4)) slaughterhouses are certified by authorities of the European Union. -----(b)(4)---- slaughterhouses possess an approval of the EU veterinary authorities and are listed on the FSIS (USDA) list as certified facilities. All slaughterhouses are regularly inspected and approved by the national veterinary authorities and are audited by Nycomed. Each batch of horse tendons supplied to Nycomed is accompanied by a veterinary certificate and by a QA certificate issued by a quality responsible person at the slaughterhouse.
Transmissible Spongiform Encephalopathy
TachoSil has an acceptable safety profile with regard to prions. TachoSil does not contain any bovine ingredients. According to current knowledge, horses do not develop prion disease. Measures to avoid cross contamination of the equine tendons are in place at the slaughterhouses. For the Active Substances - Human Fibrinogen and Human Thrombin - strict plasma donor selection criteria are employed by the manufacturer.........Full FDA document with IFU available below.....
Sunday, May 16, 2010
New treatment method in sight in cardiac surgery
A joint clinical trial conducted by the University Hospital and the University of Gothenburg, Sweden, found that an element in human blood, fibrinogen, is likely more vital to the blood's clotting ability in connection with heart surgery than previously considered. If the patients also receive a dose of fibrinogen prior to the procedure, this reduces the risk of haemorrhage during and after surgery. These results may open the door to new strategies in reducing bleeding complications in cardiac surgery.
Each year over 7,000 Swedes undergo open-heart surgery, most commonly a coronary artery bypass or a valve replacement. It's a major procedure during which the heart and lungs are stopped and their functions are temporarily replaced by a heart-lung machine, or CPB pump.
'But the use of a CPB pump has negative effects on the blood's clotting ability, and those effects last a few hours after the operation,' says Dr Martin Karlsson at Sahlgrenska Academy at the University of Gothenburg, author of the thesis. 'This leads to a risk of bleeding. It's unclear why certain patients have more problems than others, but several factors may be involved.'
Fibrinogen is one of the most important coagulation proteins in our blood, and the thesis shows that the amount of fibrinogen in the blood is more important than previously thought to ensure clotting after heart surgery.
'We found that the amount of fibrinogen in the patient's blood immediately prior to bypass surgery is directly related to how much the patient bleeds afterwards, and also to the need for blood transfusions after surgery. As a rule, patients with lower levels of fibrinogen in their blood prior to surgery bleed more, even if they have levels that were previously perceived as normal and sufficient.'
In one part of the trial, bypass patients with low levels of natural fibrinogen in their blood were pre-treated with fibrinogen concentrate before the operation. This reduced the amount of bleeding and the need for transfusions during and after surgery compared with a control group, and the pre-treated patients showed no signs of side effects.
'Treatments such as this have never been tried on patients before, and this trial was only a pilot study, with a small number of patients,' Karlsson explains. 'So it's too early to draw any real conclusions, but the results are promising and larger trials have already begun.'
Karlsson hopes that if the results of the pilot study can be confirmed, then fibrinogen concentrate could be used as a preventive therapy for patients about to undergo a surgical procedure and in other instances where the risk of haemorrhage is high. This would offer a new treatment option for the large number of patients undergoing cardiac surgery each year, possibly also for other surgical procedures.
Friday, May 7, 2010
Individual Fibrin Fibers Distribute Strain Across A Network
A new study shows that when it comes to networks of protein fibers, individual fibers play a substantial role in effectively strengthening an entire network of fibers. The research, published by Cell Press in the April 20th issue of the Biophysical Journal,describes a mechanism that explains how individual fibrin fibers subjected to significant strain can respond by stiffening to resist stretch and helping to equitably distribute the strain load across the network.
Fibrin is a fibrous protein that assembles into a remarkably strong mesh-like network and forms the structural framework of a blood clot. Failure of a clot can have fatal consequences. For example, if a portion of the clot breaks away and is carried downstream by the flowing blood, it can cause a stroke or heart attack. Although previous research has characterized the mechanical properties and behavior of fibrin networks on a macroscopic level, much less is known about the behavior of individual fibrin fibers and the distribution of strain from one fiber to the next.
"We know that network strength is determined in part by the maximum strain individual fibers can withstand, so it is of particular interest to determine how the high strain and failure characteristics of single fibrin fibers affect the overall strength of the network," says senior study author Dr. Michael R. Falvo from the Department of Physics and Astronomy at the University of North Carolina at Chapel Hill. "Further, determining how strain is shared among the constituent fiber segments in a network under imposed stress is crucial to understanding failure modes of networks and their strength."
Dr. Falvo and colleagues used a combined fluorescence/atomic force microscope nanomanipulation system to stretch two dimensional fibrin networks to the point of failure while recording the strain of individual fibers. "Specifically, we observed that as fibers were stretched, they became stiffer than the surrounding fibers at lower strains; this allowed the more strained, stiffer fibers, to distribute the strain load to the less strained fibers and reduce strain concentrations," explains Dr. Falvo. "So in effect, strain stiffening in the individual fibers acts to distribute strain equitably throughout the network and thereby strengthen it."
The strain concentration reduction effect described in this study may be part of an important physiological mechanism to strengthen blood clots under high shear conditions in the blood stream. The authors note that along with this physiological insight, their findings bring about a better understanding of this remarkable strengthening mechanism and may help to guide new design strategies for engineered materials
Fibrin is a fibrous protein that assembles into a remarkably strong mesh-like network and forms the structural framework of a blood clot. Failure of a clot can have fatal consequences. For example, if a portion of the clot breaks away and is carried downstream by the flowing blood, it can cause a stroke or heart attack. Although previous research has characterized the mechanical properties and behavior of fibrin networks on a macroscopic level, much less is known about the behavior of individual fibrin fibers and the distribution of strain from one fiber to the next.
"We know that network strength is determined in part by the maximum strain individual fibers can withstand, so it is of particular interest to determine how the high strain and failure characteristics of single fibrin fibers affect the overall strength of the network," says senior study author Dr. Michael R. Falvo from the Department of Physics and Astronomy at the University of North Carolina at Chapel Hill. "Further, determining how strain is shared among the constituent fiber segments in a network under imposed stress is crucial to understanding failure modes of networks and their strength."
Dr. Falvo and colleagues used a combined fluorescence/atomic force microscope nanomanipulation system to stretch two dimensional fibrin networks to the point of failure while recording the strain of individual fibers. "Specifically, we observed that as fibers were stretched, they became stiffer than the surrounding fibers at lower strains; this allowed the more strained, stiffer fibers, to distribute the strain load to the less strained fibers and reduce strain concentrations," explains Dr. Falvo. "So in effect, strain stiffening in the individual fibers acts to distribute strain equitably throughout the network and thereby strengthen it."
The strain concentration reduction effect described in this study may be part of an important physiological mechanism to strengthen blood clots under high shear conditions in the blood stream. The authors note that along with this physiological insight, their findings bring about a better understanding of this remarkable strengthening mechanism and may help to guide new design strategies for engineered materials
Monday, April 5, 2010
FDA Approves First Biodegradable Sealant Patch for Cardiovascular Surgery
Blood-clotting patch is absorbed by the bodySILVER SPRING, Md., April 5 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved TachoSil, the first absorbable fibrin sealant patch for use in cardiovascular surgery to prevent mild and moderate bleeding from small blood vessels, when standard surgical techniques are ineffective or impractical. TachoSil is a ready-to-use surgical patch composed of a dry collagen sponge made from horse tendons, and coated with fibrinogen and thrombin. At the site of a wound, the two proteins, through a series of chemical reactions, produce fibrin, a stringy, white, insoluble protein that allows a clot to form. The TachoSil patch is biodegradable and breaks down inside the body within four to six months. TachoSil is not intended for use within blood vessels.
"This approval provides an additional tool for surgeons to help control mild and moderate bleeding from blood vessels during cardiovascular surgery when standard surgical techniques are ineffective or impractical," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research.
The plasma used to manufacture TachoSil is collected from U.S. donors who have been screened and tested for diseases transmitted by blood. The fibrinogen and thrombin used in the surgical patch undergo additional manufacturing processes to remove impurities, including bloodborne viruses. The collagen taken from horse tendons undergoes a separate step to remove impurities, including equine viruses.
The effectiveness of TachoSil manufactured by Nycomed Austria GmbH of Linz, Austria was evaluated in a study of 119 cardiovascular surgery patients. Nearly three-quarters (74.6 percent) of those who received TachoSil, stopped bleeding within three minutes compared with 33.3 percent in the control group.
Hypersensitivity to product components or allergic reactions may occur with TachoSil. The adverse reaction rates were not statistically different between the study and control groups.
Thursday, December 3, 2009
ProFibrix Initiates Phase II Clinical Trial of its Lead Topical Hemostat Product Fibrocaps(TM)
SEATTLE, Washington, and LEIDEN, The Netherlands - ProFibrix B.V. today announced the start of the company’s Phase II clinical trial for Fibrocaps(TM), the company’s lead topical Hemostat product, with the successful treatment of the first patients for mild to moderate bleeding during liver surgery. ProFibrix expects to complete the study before the end of 2009.
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant that rapidly stops bleeding after or during surgery. Fibrocaps has major advantages over existing liquid tissue sealants: it is ready for immediate use, is stable at room temperature, highly effective and fast acting.
ProFibrix expects to submit an Investigational New Drug Application (IND) for Fibrocaps to the U.S. Food and Drug Administration in the first half of 2010, and conduct a combined phase II/III pivotal study in various surgical indications.
Jaap Koopman, PhD, Chief Executive Officer, said: “The successful treatment of the first patients with our lead product Fibrocaps is an important milestone for the company. With focus and dedication we have made enormous progress over the past two years, and we are on track to bring Fibrocaps to the point of market approval.”
About ProFibrix
ProFibrix was founded in 2004 and is headquartered in Leiden, The Netherlands, with a subsidiary in Seattle, WA. The company leverages its expertise in fibrinogen technology to develop and 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.
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant that rapidly stops bleeding after or during surgery. Fibrocaps has major advantages over existing liquid tissue sealants: it is ready for immediate use, is stable at room temperature, highly effective and fast acting.
ProFibrix expects to submit an Investigational New Drug Application (IND) for Fibrocaps to the U.S. Food and Drug Administration in the first half of 2010, and conduct a combined phase II/III pivotal study in various surgical indications.
Jaap Koopman, PhD, Chief Executive Officer, said: “The successful treatment of the first patients with our lead product Fibrocaps is an important milestone for the company. With focus and dedication we have made enormous progress over the past two years, and we are on track to bring Fibrocaps to the point of market approval.”
About ProFibrix
ProFibrix was founded in 2004 and is headquartered in Leiden, The Netherlands, with a subsidiary in Seattle, WA. The company leverages its expertise in fibrinogen technology to develop and 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.
Monday, October 26, 2009
ZymoGenetics’ Former Medical Boss Leads Rival Startup, ProFibrix
One of the key people who transformed ZymoGenetics from a basic research institute into a more balanced biotech company with both R and D, has set up shop in a rival startup just a few blocks away on Seattle’s Eastlake Avenue. If he plays his cards right, this little company will surpass his former employer, with what he hopes will be an even better treatment to control bleeding.
His name is Jan Öhrström (pronounced Yahn Oar-strum), and he’s the former chief medical officer of Seattle-based ZymoGenetics (NASDAQ:ZGEN), and now the chief operating officer of a company calledProFibrix. The newer company is headquartered in the Netherlands, and when it went looking to establish a U.S. presence a year ago, it hooked up with Öhrström to build that in Seattle. The company picked up some momentum in August when it raised $11 million in a Series B venture round, and it has some intriguing technology, so it was time to catch up with Öhrström over lunch to find out what’s up.
ProFibrix sees itself carving out a niche in the market for drugs and sealants that are used to stop excess bleeding, both in the surgical operating room and among paramedics—or on the military battlefield. The company is creating a dry powder that is ready to be used at a moment’s notice, can be sprinkled on a wound, remains stable at room temperature, and can be packaged in a spray or a bandage. It sees its potential edge in convenience when going up against standard treatments that need to be thawed, mixed with another solution, or kept in a fridge. If this new product can be proven effective in clinical trials, ProFibrix will tap into a couple different market segments worth about $600 million a year combined in the U.S.
“There’s no doubt about it, we can make significant inroads in the market,” Öhrström says.
Jan Ohrstrom
When we met over lunch near his home on Mercer Island, Öhrström was excited about getting ProFibrix set up in a new office on Eastlake, complete with all the usual mundane aspects of a startup—getting the lease signed, phones working, and the office furniture assembled (I could relate this part to when Greg and I got the Xconomy Seattle office up and running in June 2008.)
ZymoGenetics is well known for its blood coagulation expertise, although its Recothrom drug has gotten off to a slow start in sales. ProFibrix CEO Jaap Koopman, it turns out, had been cultivating a relationship with Öhrström for years, dating back to when Ohrstrom oversaw the development of recombinant thrombin (Recothrom). The vision was that if ProFibrix could get Ohrstrom on board—somebody who had technical knowledge of coagulation, expertise in leading drug development, and the experience of doing the IPO roadshow for ZymoGenetics back in 2002—then ProFibrix would have somebody who could help it attract more U.S. scientific talent, and get on the radar of U.S.-based investors.
What attracted Öhrström to the new company was ProFibrix’s lead drug candidate, which it calls Fibrocaps. It’s a tissue sealant that is derived from a pair of clotting proteins found in human blood—fibrinogen and thrombin. ProFibrix gathers those proteins from human blood, and spray dries them through a proprietary manufacturing process. That makes them into microparticles in a dry powder, which is stable at room temperature, and just needs a little liquid added (like what is found at a bleeding site) for it to spring into action and start clotting.
This sort of thing could be used by surgeons to control excess bleeding, like the ZymoGenetics drug, and could also be used by paramedics or Army medics who need something quick and convenient to stop bleeding fast, Öhrström says. It would offer a convenient alternative to fibrin sealants made by Baxter Healthcare and Johnson & Johnson, which require thawing or heating, or some kind of mixing or application device, he says.
Convenience is a big part of the story, but Öhrström got more animated talking about the science. Liquid coagulants sometimes have the disadvantage of being applied to a highly viscous bleeding site on the body, and they can run off. When these types of liquid tissue sealants are made into a spray applicator, they also sometimes clog up on the tip and don’t spray very well, Öhrström says.
The ProFibrix microparticles have the physical advantage of being able to embed themselves in any number of difficult situations that doctors and paramedics might face. “When you have a bleeding surface, it’s rarely flat. It’s got crevices,” Ohrstrom says. “A dry powder can conform to any surface.”
OK, so what kind of evidence does ProFibrix have to prove this concept? Not a lot yet. It started enrolling the first of about 20 patients in a clinical trial in June, and hopes to have results in hand by the end of this year. If it can stick to what Öhrström calls “an ambitious timeline,” then it will start a mid-stage trial in 2010 that can roll over into a pivotal study. That trial could form the basis for a new drug application to the FDA by late 2011 or early 2012, he says.
The ProFibrix group in Seattle will likely remain small, Öhrström says. The company has already recruited Linda Zuckerman from ZymoGenetics to head all preclinical development, and it will look to assemble a small team of maybe six to eight people with expertise in drug development, regulatory affairs, and business development. It doesn’t expect to have labs here. “We want to keep the payroll lean,” Öhrström says.
I had to ask Öhrström how he manages in a trans-Atlantic company, with headquarters that operate nine hours ahead of him. Ohrstrom, who is from Denmark, is used to it from his days working with Denmark-based Novo Nordisk before he joined ZymoGenetics. The new job requires that he travel a fair bit to the Netherlands, but he says he doesn’t mind, and it is actually not too much of a strain on his family life.
“My wife is Dutch, and she has family in Holland, so she’s very supportive,” Öhrström says with a laugh.
His name is Jan Öhrström (pronounced Yahn Oar-strum), and he’s the former chief medical officer of Seattle-based ZymoGenetics (NASDAQ:ZGEN), and now the chief operating officer of a company calledProFibrix. The newer company is headquartered in the Netherlands, and when it went looking to establish a U.S. presence a year ago, it hooked up with Öhrström to build that in Seattle. The company picked up some momentum in August when it raised $11 million in a Series B venture round, and it has some intriguing technology, so it was time to catch up with Öhrström over lunch to find out what’s up.
ProFibrix sees itself carving out a niche in the market for drugs and sealants that are used to stop excess bleeding, both in the surgical operating room and among paramedics—or on the military battlefield. The company is creating a dry powder that is ready to be used at a moment’s notice, can be sprinkled on a wound, remains stable at room temperature, and can be packaged in a spray or a bandage. It sees its potential edge in convenience when going up against standard treatments that need to be thawed, mixed with another solution, or kept in a fridge. If this new product can be proven effective in clinical trials, ProFibrix will tap into a couple different market segments worth about $600 million a year combined in the U.S.
“There’s no doubt about it, we can make significant inroads in the market,” Öhrström says.
Jan Ohrstrom
When we met over lunch near his home on Mercer Island, Öhrström was excited about getting ProFibrix set up in a new office on Eastlake, complete with all the usual mundane aspects of a startup—getting the lease signed, phones working, and the office furniture assembled (I could relate this part to when Greg and I got the Xconomy Seattle office up and running in June 2008.)
ZymoGenetics is well known for its blood coagulation expertise, although its Recothrom drug has gotten off to a slow start in sales. ProFibrix CEO Jaap Koopman, it turns out, had been cultivating a relationship with Öhrström for years, dating back to when Ohrstrom oversaw the development of recombinant thrombin (Recothrom). The vision was that if ProFibrix could get Ohrstrom on board—somebody who had technical knowledge of coagulation, expertise in leading drug development, and the experience of doing the IPO roadshow for ZymoGenetics back in 2002—then ProFibrix would have somebody who could help it attract more U.S. scientific talent, and get on the radar of U.S.-based investors.
What attracted Öhrström to the new company was ProFibrix’s lead drug candidate, which it calls Fibrocaps. It’s a tissue sealant that is derived from a pair of clotting proteins found in human blood—fibrinogen and thrombin. ProFibrix gathers those proteins from human blood, and spray dries them through a proprietary manufacturing process. That makes them into microparticles in a dry powder, which is stable at room temperature, and just needs a little liquid added (like what is found at a bleeding site) for it to spring into action and start clotting.
This sort of thing could be used by surgeons to control excess bleeding, like the ZymoGenetics drug, and could also be used by paramedics or Army medics who need something quick and convenient to stop bleeding fast, Öhrström says. It would offer a convenient alternative to fibrin sealants made by Baxter Healthcare and Johnson & Johnson, which require thawing or heating, or some kind of mixing or application device, he says.
Convenience is a big part of the story, but Öhrström got more animated talking about the science. Liquid coagulants sometimes have the disadvantage of being applied to a highly viscous bleeding site on the body, and they can run off. When these types of liquid tissue sealants are made into a spray applicator, they also sometimes clog up on the tip and don’t spray very well, Öhrström says.
The ProFibrix microparticles have the physical advantage of being able to embed themselves in any number of difficult situations that doctors and paramedics might face. “When you have a bleeding surface, it’s rarely flat. It’s got crevices,” Ohrstrom says. “A dry powder can conform to any surface.”
OK, so what kind of evidence does ProFibrix have to prove this concept? Not a lot yet. It started enrolling the first of about 20 patients in a clinical trial in June, and hopes to have results in hand by the end of this year. If it can stick to what Öhrström calls “an ambitious timeline,” then it will start a mid-stage trial in 2010 that can roll over into a pivotal study. That trial could form the basis for a new drug application to the FDA by late 2011 or early 2012, he says.
The ProFibrix group in Seattle will likely remain small, Öhrström says. The company has already recruited Linda Zuckerman from ZymoGenetics to head all preclinical development, and it will look to assemble a small team of maybe six to eight people with expertise in drug development, regulatory affairs, and business development. It doesn’t expect to have labs here. “We want to keep the payroll lean,” Öhrström says.
I had to ask Öhrström how he manages in a trans-Atlantic company, with headquarters that operate nine hours ahead of him. Ohrstrom, who is from Denmark, is used to it from his days working with Denmark-based Novo Nordisk before he joined ZymoGenetics. The new job requires that he travel a fair bit to the Netherlands, but he says he doesn’t mind, and it is actually not too much of a strain on his family life.
“My wife is Dutch, and she has family in Holland, so she’s very supportive,” Öhrström says with a laugh.
Wednesday, October 14, 2009
Patch Uses Stem Cells To Plug Holes in The Heart
They say only time heals a broken heart, but Duke University researchers think they can do better. Using embryonic stem cells from mice and their own novel molding technique, a team of researchers at Duke has developed a three-dimensional heart cell “patch” that conducts electrical impulses and contracts, two all important characteristics of heart tissue.
Cardiomyocytes, the heart muscle cells that keep the blood pumping, are difficult to grow effectively because left to their own devices, they will simply develop into a disorganized clump of cells. To get around this, the team coaxed embryonic stem cells to develop into cardiomyocytes by placing them in an environment much like the one in which they develop naturally. By encapsulating the cells in a gel made of fibrin, a blood-clotting protein, the researchers provided the mechanical support for the cells to form an organized, three-dimensional structure.But the key ingredient for the researchers were helper cells called cardiac fibroblasts. These cells make up as much as 60 percent of the cells present in the heart, and when introduced to the mold they caused the cardiomyocytes to pull together as if they were growing in a developing human heart. The alignment of the cells in the correct direction allows them to contract and carry electrical signals as though they are native tissue, allowing them to function fairly seamlessly alongside existing heart tissue.
After being cast in the fibrin mold, the patches can be placed on the heart where the tissue is thin or compromised and injected with cells that would then generate new heart tissue. But obstacles remain; aside from the many regulatory hurdles a procedure like the heart patch must leap, engineering a blood vessel supply to sustain the patch also presents substantial challenges. The use of embryonic stem cells also invites controversy, so the Duke team also plans to test their patch using non-embryonic stem cells. Ethical and regulatory issues aside, the proof of concept is an important breakthrough for cardiac researchers who have a limited arsenal with which to battle heart disease, the leading cause of death in many developed countries. An effective non-embyronic stem cell heart patch would not only circumvent the problem of immune system reactions, but sidestep sensitive ethical land mines, clearing the way to put broken hearts on the mend.
Sunday, September 13, 2009
Haemacure presentation
MONTREAL, Sept. 14 /PRNewswire-FirstCall/ - Haemacure Corporation (TSX : HAE) reported today on current activities and released the financial results of its third quarter endedJuly 31.
Current Activities
Haemacure and Angiotech Pharmaceuticals, Inc. started work pursuant to the strategic collaboration entered into inJune 2009, including the shipment of product to Angiotech. This collaboration provides Angiotech with license, distribution and supply rights for Haemacure's all-human fibrin sealant and thrombin products, both of which are in development.
Haemacure is actively preparing for the pivotal phase II/III clinical trials for its fibrin sealant and is seeking additional financing.
"We are very pleased with the strategic collaboration Haemacure entered into with Angiotech, which provides liquidity and an important validation of our company and its product candidates." said Joseph Galli, Chairman and Chief Executive Officer of Haemacure. "In addition, we are in discussion with other parties who need fibrin sealant and thrombin to enable their products." concluded Mr. Galli.
Financial Position
Cash, cash equivalents and investments amounted to$336,598 as at July 31, 2009, as compared to $4.6 million as at October 31, 2008. Haemacure estimates that it has cash, and access to liquidity as a result of the transaction with Angiotech, to enable it to operate until the end of calendar year 2009.
Results
Revenues amounted to $15,390, as compared to $25,593 for the same quarter last year. Revenues were exclusively derived from the sale of legacy fibrin sealant application devices. Operating expenses amounted to $824,634, down from $2 million for the same quarter last year. The decrease was mainly attributable to foreign exchange fluctuation and the major cost cutting measures implemented in February 2009 to preserve cash. The consolidated net loss for the quarter amounted to $798,852, or nil per share, as compared to $2 million, or $0.01 per share, for the same quarter last year.
Current Activities
Haemacure and Angiotech Pharmaceuticals, Inc. started work pursuant to the strategic collaboration entered into inJune 2009, including the shipment of product to Angiotech. This collaboration provides Angiotech with license, distribution and supply rights for Haemacure's all-human fibrin sealant and thrombin products, both of which are in development.
Haemacure is actively preparing for the pivotal phase II/III clinical trials for its fibrin sealant and is seeking additional financing.
"We are very pleased with the strategic collaboration Haemacure entered into with Angiotech, which provides liquidity and an important validation of our company and its product candidates." said Joseph Galli, Chairman and Chief Executive Officer of Haemacure. "In addition, we are in discussion with other parties who need fibrin sealant and thrombin to enable their products." concluded Mr. Galli.
Financial Position
Cash, cash equivalents and investments amounted to$336,598 as at July 31, 2009, as compared to $4.6 million as at October 31, 2008. Haemacure estimates that it has cash, and access to liquidity as a result of the transaction with Angiotech, to enable it to operate until the end of calendar year 2009.
Results
Revenues amounted to $15,390, as compared to $25,593 for the same quarter last year. Revenues were exclusively derived from the sale of legacy fibrin sealant application devices. Operating expenses amounted to $824,634, down from $2 million for the same quarter last year. The decrease was mainly attributable to foreign exchange fluctuation and the major cost cutting measures implemented in February 2009 to preserve cash. The consolidated net loss for the quarter amounted to $798,852, or nil per share, as compared to $2 million, or $0.01 per share, for the same quarter last year.
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