Octapharma

Octapharma

Austria - Vienna
Pharmaceutical
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Focus: Plasma Products

Octapharma is a life sciences company focused on Plasma Products.

Rare Diseases
Funding Stage
SERIES A
Employees
5000+
Open Jobs
0

Products & Portfolio (7)

Albumin (Human)
albumin human
LOE Approaching
INTRAVENOUS · SOLUTION
glycoprotein. It has the lowest molecular weight (66,241 Daltons) of all plasma proteins. Because of its three dimensional structure, solutions of albumin have a lower viscosity than solutions of other plasma proteins. This is important since work performed by the heart depends in part on the viscosity of blood. Human albumin accounts quantitatively for more than half of the total proteins in the circulation (by weight) and represents approximately 10 % of the protein synthesized in the liver. Approximately 40% of albumin is contained in the circulation. The remainder is located in the extravascular space of tissues, principally muscle, skin, and intestine. KEDBUMIN 25% has a hyperoncotic effect. A major function of albumin is its role in osmotic regulation. Albumin is responsible for 75% of normal oncotic pressure within the intravascular space [13, 14]. Other physiological functions include binding and transport of molecules (hormones, enzymes, drugs and toxins); free radical scavenging; hemostatic effects (platelet function inhibition and antithrombotic effects); and capillary membrane permeability [14].
conjunction with diuretics to correct fluid volume overload associated with ARDS [5]for those patientshypotension [7]+1 more
2006
30
Balfaxar
prothrombin complex concentrate (human)
Growth
INTRAVENOUS · POWDER, FOR SOLUTION
12.1 Mechanism of Action The administration of BALFAXAR provides a rapid increase in plasma levels of the vitamin K-dependent coagulation factors (FII, FVII, FIX, FX) and antithrombotic proteins C and S. Together they are referred to/known as the prothrombin complex. [ ; ] BALFAXAR can temporarily correct the coagulation defect of patients with deficiency of one or several of these factors. 12.2 Pharmacodynamics In the randomized controlled trial in urgent surgery, the INR was determined at varying time points after the end of infusion. The median INR was 3.0 prior to the infusion and dropped to a median value of 1.30 by the 30-minute time point after the end of infusion. After 24 hours it was 1.25 in the BALFAXAR group (see ). The relationship between these or other INR values and clinical hemostasis in patients has not been established [see ( )]. Table 5 Median INR (Min-Max) After End of Infusion in Urgent Surgery RCT Treatment Baseline 30 min 2 hr 4 hr 12 hr 24 hr BALFAXAR (N=105) 3.05 (2.0 - 21.1) 1.30 (1.0 – 3.1) 1.28 (1.0 - 2.5) 1.30 (1.0 - 2.0) 1.30 (0.9 - 2.7) 1.25 (0.8 - 3.4) 12.3 Pharmacokinetics Since BALFAXAR is given intravenously, bioavailability is proportional to the dose administered. BALFAXAR is distributed, metabolized, and excreted in the same manner as the endogenous proteins (see ). Table 6 Pharmacokinetic Parameters and Recovery of Coagulation Factors, Protein C and Protein S Parameter FII FVII FIX FX Protein C Protein S C max (%) 62.42/1.33(37.00-118.00) 30.58/1.55(13.00-81.00) 57.57/1.55(27.00-130.00) 51.03/1.41(30.00-120.00) 59.95/1.35(38.00-109.00) 63.20/1.39(30.00-115.00) C max,norm (%/IU/kg) 2.38/1.23(1.38-2.96) 1.16/1.51(0.48-2.11) 2.19/1.65(0.84-4.71) 1.94/1.26(1.08-2.74) 2.28/1.31(1.17-3.45) 2.41/1.41(0.90-3.95) Incremental Recovery** (%/IU/kg) 1.73/1.33(0.81-2.42) 0.68/1.88(0.11-1.62) 1.17/1.83(0.26-2.52) 1.47/1.34(0.73-2.38) 1.25/0.54*(0.00-2.22) 1.47/1.52(0.59-2.35) Absolute Recovery*** (%) 75.70/1.34(32.65-116.98) 29.64/1.90(4.45-78.35) 51.36/1.82(13.54-115.58) 64.39/1.37(29.68-114.8) 54.95/24.60*(0.00-107.04) 64.26/1.55(23.74-113.66) t max 0.17(0.17-3.00) 0.17(0.17-1.00) 0.50(0.17-3.00) 0.17(0.17-3.00) 0.17(0.00-3.00) 0.17(0.17-3.00) Note: Values reported as geometric mean/geometric SDs (range), except for t max which is reported as median (min-max) *Mean values SD (due to zero values, the geometric mean could not be calculated) **The incremental recovery is defined as the rise in the plasma concentrations (%) achieved with 1 IU BALFAXAR/kg BW. ***The absolute recovery is defined as the rise in the plasma concentrations (%) achieved by the dose.
2023
30
Cutaquig
immunoglobulin g
Peak
SUBCUTANEOUS · SOLUTION
(IgG) antibodies against a wide variety of bacterial and viral agents. It has a distribution of immune globulin subclasses closely proportional to that in native human plasma. The mechanism of action in primary humoral immunodeficiency (PI) has not been fully elucidated; however adequate doses may restore abnormally low immune globulin G levels to the normal range and thus help in preventing infections.
primary humoral immunodeficiency (PI) in adultsolder
2019
30
Octagam Immune Globulin (Human)
immune globulin
LOE Approaching
INTRAVENOUS · SOLUTION
2004
30
Octaplas
human plasma proteins
Peak
INTRAVENOUS · SOLUTION
2013
30
Panzyga
immune globulin intravenous (human)
Peak
INTRAVENOUS · SOLUTION
2018
30
Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human)
von willebrand factor/coagulation factor viii complex (human)
LOE Approaching
INTRAVENOUS · POWDER, FOR SOLUTION
2009
30

Pipeline & Clinical Trials

Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Tre
Haemophilia A
N/A
Clinical Trials (1)
NCT03695978Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
N/A
N/A
Clinical Trials (1)
NCT04354129Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency.
N/A
Octaplas™
Coagulopathy
N/A
Clinical Trials (1)
NCT02037373Evaluation of the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation
N/A
Immunological diagnosis tests
Complement Deficiency
N/A
Clinical Trials (1)
NCT02972281Systematic Search for Primary Immunodeficiency in Adults With Infections
N/A
Fibryga
Bleeding
N/A
Clinical Trials (1)
NCT04106895Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data
N/A
N/A
Clinical Trials (1)
NCT03320603Use of Prothrombin Complex Concentrate in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants
N/A
Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of
Hemophilia A
N/A
Clinical Trials (1)
NCT02962765Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ
N/A
N/A
Clinical Trials (1)
NCT04023019Treatment of Hemophilia A Patients With FVIII Inhibitors
N/A
N/A
Clinical Trials (1)
NCT03369301The Effect of Subcutaneous Immunoglobulin Gammanorm on the Distribution of IgG Subclasses and on Immunity of Patients With Secondary Immunodeficiency
N/A
N/A
Clinical Trials (1)
NCT02111590Immunoglobulin Dosage and Administration Form in CIDP and MMN
N/A
N/A
Clinical Trials (1)
NCT04106908Effectiveness and Tolerability of Eqwilate in Real-life Conditions
N/A
Wilate or Nuwiq
Hemophilia A
N/A
Clinical Trials (1)
NCT03344003Immune Tolerance Induction in Haemophilia A Patients Using Wilate or Nuwiq
N/A
A Prospective, Global, Multi-center, Treatment Registry Study of Intravenous Immunoglobulin Maintena
Renal Transplant Recipients With Anti-HLA Antibodies
N/A
Clinical Trials (1)
NCT02115503A Prospective, Global, Multi-center, Treatment Registry Study of Intravenous Immunoglobulin Maintenance Therapy in Alloantibody Positive Renal Allograft Recipients
N/A
N/A
Clinical Trials (1)
NCT03656640Trial Assessing Safety and Efficacy of Gammanorm® in Autoimmune Diseases
N/A
Von Willebrand Factor-Containing Product
Von Willebrand Diseases
N/A
Clinical Trials (1)
NCT04053699Bleeding Incidence in VWD Patients Undergoing On-Demand Treatment
N/A
ATHN 8: Previously Untreated Patients (PUPs) Matter Study
Hemophilia
N/A
Clinical Trials (1)
NCT03818529ATHN 8: Previously Untreated Patients (PUPs) Matter Study
N/A
N/A
Clinical Trials (1)
NCT02303093Non-Interventional Study on the Tolerability and Efficacy of IVIG
N/A
Patients using Wilate as standard of care
Von Willebrand Disease
N/A
Clinical Trials (1)
NCT01602419Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease
N/A
N/A
Clinical Trials (1)
NCT01859754Octagam 5% Versus Comparator Post Marketing Trial
N/A
N/A
Clinical Trials (1)
NCT01938404Octaplas Adult TTP Trial
N/A
N/A
Clinical Trials (1)
NCT03369314Observational Study of the Use of octaplasLG®.
N/A
N/A
Clinical Trials (1)
NCT06429787Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure
N/A
Antithrombin III
Covid19
N/A
Clinical Trials (1)
NCT04651400Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection
N/A
Use of a postpartum diary and additional blood draws
Von Willebrand Diseases
N/A
Clinical Trials (1)
NCT04146376Von Willebrand Factor in Pregnancy (VIP) Study
N/A
N/A
Clinical Trials (1)
NCT03793426Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency
N/A
Phase 1
Clinical Trials (1)
NCT01063595A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD
Phase 1
Phase 1/2
Clinical Trials (1)
NCT04046848Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A
Phase 1/2
Phase 2
Clinical Trials (1)
NCT06599697The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy
Phase 2
Phase 2
Clinical Trials (1)
NCT03385395Study Comparing Weekly Intravenous Administration of OctaAlpha1 With a Marketed Preparation Glassia® in Subjects With Alpha-1-antitrypsin Deficiency
Phase 2
Phase 2
Clinical Trials (1)
NCT01575756Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
Phase 2
Phase 2
Clinical Trials (1)
NCT04153422IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies
Phase 2
OctaplasLG
Septic Shock
Phase 2
Clinical Trials (1)
NCT03092245Vasculopathic Injury and Plasma as Endothelial Rescue in Septic Shock (SHOCK) Trial
Phase 2
Phase 2
Clinical Trials (1)
NCT00812565Study of Octagam (Intravenous Immunoglobulin [IVIG]) 10% on the Treatment of Mild to Moderate Alzheimer's Disease
Phase 2
Human-cl rhFVIII
Hemophilia A
Phase 2
Clinical Trials (1)
NCT00989196Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A
Phase 2
Phase 2/3
Clinical Trials (1)
NCT01225276Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP
Phase 2/3
Phase 2/3
Clinical Trials (1)
NCT00545493Efficacy of Tacrolimus and I.V.-Immunoglobulins in Rasmussen Encephalitis
Phase 2/3
Phase 3
Clinical Trials (1)
NCT04953884Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease (VWD) Patients <6 Years of Age
Phase 3
Phase 3
Clinical Trials (1)
NCT00426270Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults
Phase 3
Phase 3
Clinical Trials (1)
NCT03907241CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
Phase 3
Phase 3
Clinical Trials (1)
NCT04052698Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With VWD
Phase 3
Phase 3
Clinical Trials (1)
NCT06361537Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks
Phase 3
Human cl rhFVIII
Severe Haemophilia A
Phase 3
Clinical Trials (1)
NCT02256917Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
Phase 3
Phase 3
Clinical Trials (1)
NCT02638207Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy
Phase 3
Phase 3
Clinical Trials (1)
NCT01012323A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases
Phase 3
Phase 3
Clinical Trials (1)
NCT03939533Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases
Phase 3
Phase 3
Clinical Trials (1)
NCT01888484Study of Octanorm Subcutaneous IG in Patients With PID
Phase 3
Phase 3
Clinical Trials (1)
NCT04918173Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery
Phase 3
Human cl rhFVIII
Severe Hemophilia A
Phase 3
Clinical Trials (1)
NCT01712438Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients
Phase 3
recombinant Factor VIII
Severe Hemophilia A
Phase 3
Clinical Trials (1)
NCT01125813Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A
Phase 3
human VWF/FVIII concentrate
Prevent Bleeding in Major Surgery
Phase 3
Clinical Trials (1)
NCT01365546Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery
Phase 3

Open Jobs (0)

No open positions listed yet. Check their careers page directly.

Interview Prep Quick Facts
Founded: 2020
Portfolio: 7 approved products, 90 clinical trials
Top TAs: Rare Diseases, Neurology, Hematology
Publications: 25 in PubMed
Portfolio Health
Growth1 (14%)
Peak3 (43%)
LOE Approaching3 (43%)
7 total products
Therapeutic Area Focus
Rare Diseases
14 pipeline
Neurology
6 pipeline
Hematology
1 marketed3 pipeline
Immunology
4 pipeline
Cardiovascular
1 marketed1 pipeline
Respiratory
1 marketed
Marketed
Pipeline