Fibrinogen

EQS-News: Biotest AG increased sales by 32% in the financial year 2023

Retrieved on: 
Wednesday, April 10, 2024

In the financial year 2023, the Biotest Group generated revenue of € 684.6 million compared with € 516.1 million in the previous year.

Key Points: 
  • In the financial year 2023, the Biotest Group generated revenue of € 684.6 million compared with € 516.1 million in the previous year.
  • The consolidated EBIT result in the 2023 financial year of € 143.5 million improved considerably compared with € -16.6 million in the previous year.
  • In September 2023, Biotest reached an important milestone in the marketing authorisation process for Yimmugo® in the USA.
  • The 2023 Annual Report and the 2023 Sustainability Report are available on the company's website.

NodThera’s NLRP3 Inhibitor NT-0796 Reverses Neuroinflammation in Parkinson’s Disease Phase Ib/IIa Trial

Retrieved on: 
Thursday, March 7, 2024

IL-1β, IL-6, CCL2, CXCL1 and CXCL8) over 28 days compared to baseline to levels approximating those of healthy elderly controls, demonstrating reversal of NLRP3-mediated neuroinflammation.

Key Points: 
  • IL-1β, IL-6, CCL2, CXCL1 and CXCL8) over 28 days compared to baseline to levels approximating those of healthy elderly controls, demonstrating reversal of NLRP3-mediated neuroinflammation.
  • In addition, reductions in neurodegenerative markers were also observed following oral dosing of NT-0796, including NfL and soluble TREM (sTREM2).
  • The correlation between Parkinson’s disease and neuroinflammation is well-documented, with alpha-synuclein fibrils triggering microglial NLRP3 activation, leading to neuroinflammation and subsequent neurodegeneration.
  • This is the inaugural demonstration of an NLRP3 inhibitor’s potential to not only address Parkinson’s disease but also offer a broader impact on neurodegenerative diseases.

NodThera Publishes Preclinical Data Demonstrating Reversal of Obesity and Inflammation with Clinical-stage Brain-penetrant NLRP3 Inflammasome Inhibitors

Retrieved on: 
Monday, February 19, 2024

The data are published in the Journal of Pharmacology and Experimental Therapeutics in a paper titled ‘Reversal of high fat diet-induced obesity, systemic inflammation and astrogliosis by the NLRP3 inflammasome inhibitors NT-0249 and NT-0796’1.

Key Points: 
  • The data are published in the Journal of Pharmacology and Experimental Therapeutics in a paper titled ‘Reversal of high fat diet-induced obesity, systemic inflammation and astrogliosis by the NLRP3 inflammasome inhibitors NT-0249 and NT-0796’1.
  • The NLRP3 inflammasome is a highly validated anti-inflammatory drug target, and these findings demonstrate that NLRP3 plays a key role in controlling obesity and obesity-associated inflammation through the modulation of hypothalamic gliosis.
  • Both NT-0796 and NT-0249, two structurally distinct NLRP3 inhibitors in clinical development by NodThera, have generated a wealth of preclinical and clinical data demonstrating brain-penetration and broad anti-inflammatory effects, with NT-0796 being the first NLRP3 inhibitor to show reduced neuroinflammation in the clinic.
  • Our ongoing Phase IIa study in obese individuals at cardiovascular risk will further validate these pre-clinical findings.”
    Reversal of High Fat Diet-Induced Obesity, Systemic Inflammation, and Astrogliosis by the NLRP3 Inflammasome Inhibitors NT-0249 and NT-0796.

Grifols announces positive topline phase 3 fibrinogen clinical trial results

Retrieved on: 
Wednesday, February 14, 2024

AFD, which typically occurs during surgical procedures when there’s insufficient fibrinogen to arrest bleeding, is commonly treated with cryoprecipitate (a plasma extract) or fresh frozen plasma, both containing fibrinogen.

Key Points: 
  • AFD, which typically occurs during surgical procedures when there’s insufficient fibrinogen to arrest bleeding, is commonly treated with cryoprecipitate (a plasma extract) or fresh frozen plasma, both containing fibrinogen.
  • Fibrinogen, a plasma protein produced in the liver, plays a key role in stopping blood loss and in wound healing.
  • “The positive results for Biotest’s fibrinogen are an important milestone and strengthen a Grifols innovation strategy that’s diversified across plasma and non-plasma, balanced between internal and external investments, and includes both shorter- and longer-term development cycles,” said Victor Grifols Deu, Grifols Chief Operating Officer.
  • The acquisition of Biotest has significantly reinforced Grifols’ access to plasma, as well as the company’s pipeline and sales presence.

EQS-News: Biotest successfully meets primary endpoint in phase III trial with Fibrinogen concentrate

Retrieved on: 
Wednesday, February 14, 2024

Biotest announced today that the AdFIrst (Adjusted FIbrinogen replacement strategy) phase III trial met its primary endpoint, demonstrating that Fibrinogen concentrate is non-inferior to standard of care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency undergoing planned major spinal or abdominal surgery.

Key Points: 
  • Biotest announced today that the AdFIrst (Adjusted FIbrinogen replacement strategy) phase III trial met its primary endpoint, demonstrating that Fibrinogen concentrate is non-inferior to standard of care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency undergoing planned major spinal or abdominal surgery.
  • The AdFIrst trial was a prospective, randomised, active-controlled, multicentre phase III trial involving 222 patients undergoing elective spine or abdominal surgery.
  • This would be the first fibrinogen concentrate approved for an acquired fibrinogen deficiency indication in the US.
  • Compared with congenital fibrinogen deficiency, where efficacy has been demonstrated in an earlier trial, the market size for the treatment of acquired fibrinogen deficiency is many times larger.

Valbiotis announces the success of the TOTUM•63 mode of action clinical study, against prediabetes and the early stages of type 2 diabetes

Retrieved on: 
Wednesday, November 8, 2023

Valbiotis announces the success of the TOTUM•63 mode of action clinical study, against prediabetes and the early stages of type 2 diabetes

Key Points: 
  • Valbiotis announces the success of the TOTUM•63 mode of action clinical study, against prediabetes and the early stages of type 2 diabetes
    Dissemination of a French Regulatory News, transmitted by EQS Group.
  • The study confirms TOTUM•63's efficacy results, in particular the lasting reduction in glycated hemoglobin, one of the main markers of prediabetes and type 2 diabetes.
  • It demonstrates TOTUM•63's multi-target mode of action in subjects at risk, improving the efficacy of energy metabolism, particularly after meals.
  • Mode of action clinical results: TOTUM•63 regulates energy metabolism
    In addition to the positive clinical efficacy studies already conducted, the mode of action study was carried out on 19 overweight or obese volunteers at risk of developing type 2 diabetes.

EQS-News: Biotest increases EBIT to Euro 125.4 million in the first nine months of 2023

Retrieved on: 
Tuesday, November 7, 2023

This development is due to the higher income taxes in connection with the earnings effect from technology disclosure and development services.

Key Points: 
  • This development is due to the higher income taxes in connection with the earnings effect from technology disclosure and development services.
  • This is equivalent to earnings per ordinary share of € 2.22 compared with € - 0.87 in the same period of the previous year.
  • In September 2023, Biotest also reached an important milestone in the marketing authorisation process for Yimmugo in the USA.
  • This revenue growth is enabled by the commissioning of the Yimmugo® production facility within Biotest Next Level.

Octapharma USA Presents Factor Concentrates for Perioperative Bleeding Symposium for ASA Annual Meeting Attendees

Retrieved on: 
Tuesday, October 10, 2023

PARAMUS, N.J., Oct. 10, 2023 /PRNewswire/ -- Octapharma USA will sponsor the scientific symposium, Factor Concentrates for Perioperative Bleeding – Global Perspectives, Sunday, October 15th in conjunction with the American Society of Anesthesiologists (ASA) Annual Meeting in San Francisco.

Key Points: 
  • PARAMUS, N.J., Oct. 10, 2023 /PRNewswire/ -- Octapharma USA will sponsor the scientific symposium, Factor Concentrates for Perioperative Bleeding – Global Perspectives, Sunday, October 15th in conjunction with the American Society of Anesthesiologists (ASA) Annual Meeting in San Francisco.
  • The symposium will address current gaps in research related to factor concentrates, including prothrombin complex concentrates (PCC) and fibrinogen concentrates (FC), for perioperative bleeding management.
  • Kamrouz Ghadimi, MD, MHSc, Department of Anesthesiology, Duke University, will discuss, "Perioperative Coagulopathic Bleeding – Definition, Treatment Algorithms, and POC Testing, Oh My!"
  • The role of factor concentrates and blood products for management of bleeding in surgery;
    The latest research and current practice guidelines for factor concentrates in perioperative bleeding; and
    Individualized bleeding management strategies in cardiac surgery, with patient case presentations.

EQS-News: Biotest AG: Biotest increases EBIT to Euro 19.8 million in the first half of 2023

Retrieved on: 
Thursday, August 10, 2023

The Biotest Group's total earnings after tax (EAT) increased to € 1.7 million in the first half of 2023 (same period of the previous year: € - 19.9 million) in view of the influencing factors described.

Key Points: 
  • The Biotest Group's total earnings after tax (EAT) increased to € 1.7 million in the first half of 2023 (same period of the previous year: € - 19.9 million) in view of the influencing factors described.
  • This results in earnings per ordinary share of € 0.03 after € - 0.50 in the first half of 2022.
  • Biotest develops Fibrinogen not only for congenital but also for acquired fibrinogen deficiency.
  • This increase in sales is possible due to the commissioning of the Yimmugo® production facility within Biotest Next Level.

Baxter Launches PERCLOT Absorbable Hemostatic Powder

Retrieved on: 
Monday, July 24, 2023

Baxter International Inc. (NYSE:BAX), a global leader in advancing surgical innovation, today announced the launch of PERCLOT Absorbable Hemostatic Powder in the U.S. PERCLOT is a passive, absorbable hemostatic powder that is ready to use and designed for patients with intact coagulation to address mild bleeding.1

Key Points: 
  • Baxter International Inc. (NYSE:BAX), a global leader in advancing surgical innovation, today announced the launch of PERCLOT Absorbable Hemostatic Powder in the U.S. PERCLOT is a passive, absorbable hemostatic powder that is ready to use and designed for patients with intact coagulation to address mild bleeding.1
    This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20230724490511/en/
    “PERCLOT is a strong complement to Baxter’s leading hemostat portfolio,” said Steve Wallace, president, Advanced Surgery at Baxter.
  • PERCLOT further enhances clinicians’ ability to optimize patient care by addressing a broader range of intraoperative bleeding.
  • Baxter has successfully continued to expand the global commercial presence of PERCLOT since acquiring the product in July 2021 .