Swedish Orphan Biovitrum

Swedish Orphan Biovitrum

MA - Waltham
Biotechnology
WebsiteLinkedInCareers Page

Focus: Biologics

Swedish Orphan Biovitrum is a life sciences company focused on Biologics.

Rare DiseasesOncologyImmunologyMetabolic DiseasesHematology
Funding Stage
PUBLIC
Open Jobs
0

Products & Portfolio (5)

KEPIVANCE
palifermin
LOE Approaching
INJECTION · INJECTABLE
(FGF) family that binds to the KGF receptor. Binding of KGF to its receptor has been reported to result in proliferation, differentiation, and migration of epithelial cells. The KGF receptor, one of four receptors in the FGF family, has been reported to be present on epithelial cells in many tissues examined including the tongue, buccal mucosa, esophagus, stomach, intestine, salivary gland, lung, liver, pancreas, kidney, bladder, mammary gland, skin (hair follicles and sebaceous gland), and the lens of the eye. The KGF receptor has been reported to not be present on cells of the hematopoietic lineage. Endogenous KGF is produced by mesenchymal cells and is upregulated in response to epithelial tissue injury. In mice and rats, Kepivance enhanced proliferation of epithelial cells (as measured by Ki67 immunohistochemical staining and BrDU uptake) and demonstrated an increase in tissue thickness of the tongue, buccal mucosa, and gastrointestinal tract. Kepivance has been studied in murine models of chemotherapy and radiation-induced gastrointestinal injury. In such models, administration of Kepivance prior to and/or after the cytotoxic insult improved survival and reduced weight loss compared to control animals. Kepivance has been shown to enhance the growth of human epithelial tumor cell lines in vitro at concentrations ≥ 10 mcg/mL (> 15-fold higher than average therapeutic concentrations in humans). In nude mouse xenograft models, three consecutive daily treatments of Kepivance at doses of 1,500 and 4,000 mcg/kg (25- and 67-fold higher than the recommended human dose, respectively) repeated weekly for 4 to 6 weeks were associated with a dose-dependent increase in the growth rate of 1 of 7 KGF receptor-expressing human tumor cell lines.
incidenceduration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support
2004
30
KINERET
anakinra
LOE Approaching
SUBCUTANEOUS · VIAL
Interleukin 1 Receptor Antagonists
2001
30
ORFADIN
nitisinone
LOE Approaching
ORAL · CAPSULE
Hydroxyphenylpyruvate Dioxygenase Inhibitors
2002
30
ORFADIN
nitisinone
Peak
ORAL · SUSPENSION
Hydroxyphenylpyruvate Dioxygenase Inhibitors
2016
0
SYNAGIS
palivizumab
LOE Approaching
mAbINTRAMUSCULAR · VIAL
Fusion Protein Inhibitors
1998
30

Pipeline & Clinical Trials

N/A
Clinical Trials (1)
NCT03259230Evaluation of IFNγ and Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis
N/A
Ultrasound, Haemophilia Joint Health Score
Hemophilia A
N/A
Clinical Trials (1)
NCT04133883Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination
N/A
N/A
Clinical Trials (1)
NCT03655340A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France
N/A
N/A
Clinical Trials (1)
NCT03951103rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A
N/A
Standard care with blood and urine sample collection
Factor IX Deficiency
N/A
Clinical Trials (1)
NCT02502409Natural History Study of Factor IX Treatment and Complications
N/A
Blood Draws Data Collection
Hemophagocytic Lymphohistiocytoses
N/A
Clinical Trials (1)
NCT06047210Evaluation of IFNγ and Inflammatory Mediators in Patients With Hemophagocytic Lymphohistiocytosis
N/A
Hemophilia Joint Health Score
Hemophilia A
N/A
Clinical Trials (1)
NCT04731701Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)
N/A
feasibility study
Sonography
N/A
Clinical Trials (1)
NCT04550988Sonography and Haemophilia
N/A
N/A
Clinical Trials (1)
NCT05776472A Real World Effectiveness Study of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
N/A
Assessment of Macrophage Activation syndromE in STill's Disease in Italy
Macrophage Activation Syndrome (MAS)
N/A
Clinical Trials (1)
NCT06992505Assessment of Macrophage Activation syndromE in STill's Disease in Italy
N/A
N/A
Clinical Trials (1)
NCT02320084Long Term Safety Study of Orfadin Treatment in HT-1 Patients in Standard Clinical Care
N/A
Alprolix
Hemophilia B
N/A
Clinical Trials (1)
NCT03901755An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
N/A
rFVIIIFc
Hemophilia A
N/A
A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia C
Haemophilia A
N/A
Clinical Trials (1)
NCT02049099A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care
N/A
N/A
Clinical Trials (1)
NCT04293523A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health
N/A
N/A
Clinical Trials (1)
NCT03055611A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
N/A
N/A
Clinical Trials (1)
NCT03932344Long-term Safety Study of Kineret® in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
N/A
N/A
Clinical Trials (1)
NCT06227429A Non-interventional, Post-Marketing Study to Describe Outcome of Nitisinone Treatment in HT-1 Patients
N/A
Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With
Haemophilia A
N/A
Clinical Trials (1)
NCT03276130Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
N/A
ITP Registry and Accompanying Biospecimen Collection
Immune Thrombocytopenia
N/A
efmoroctocog alfa
Hemophilia A
N/A
Clinical Trials (1)
NCT02976753Prospective, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products
N/A
Trabectedin/Caelyx vs Cisplatin Hypersensitivity in Relapsed Ovarian Cancer Patients Allergic to Pla
Ovarian Neoplasm
N/A
Clinical Trials (1)
NCT05512676Trabectedin/Caelyx vs Cisplatin Hypersensitivity in Relapsed Ovarian Cancer Patients Allergic to Platinum
N/A
N/A
Clinical Trials (1)
NCT02915094Kineret in the Treatment of Rheumatoid Arthritis
N/A
N/A
Clinical Trials (1)
NCT06405152Assessment of Macrophage Activation syndromE in STill's Disease
N/A
N/A
Clinical Trials (1)
NCT04943042An Observational, Multicenter Study to Evaluate the Use and Effectiveness of Doptelet® in Patients With ITP
N/A
blood collection
Graft Failure
N/A
Clinical Trials (1)
NCT04494061A Clinical Study to Investigate Interferon Gamma (IFNɣ) Signature in Patients Post HSCT and in Patients With Impaired HSC Proliferation Pre-transplant
N/A
Hemophilia Early Arthropathy Detection with Ultrasound
Haemophilia A
N/A
Clinical Trials (1)
NCT06352216Prevalence of Synovitis in Patients With Haemophilia A
N/A
N/A
Clinical Trials (1)
NCT02326376Kineret CAPS Post Authorisation Study
N/A
Palifermin
Oral Mucositis
Phase 1
Clinical Trials (1)
NCT01163097Study to Characterize the Effect of Heparin on Palifermin Activity
Phase 1
Phase 1
Clinical Trials (1)
NCT00361348Palifermin DDI (Drug Drug Interaction)
Phase 1
Nitisinone in Arm A
Drug Drug Interaction
Phase 1
Clinical Trials (1)
NCT03103568A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers
Phase 1
Phase 1
Clinical Trials (1)
NCT04765553A Study to Evaluate Emapalumab in Japanese Healthy Volunteers.
Phase 1
Phase 1
Nitisinone, capsule
Healthy Volunteers
Phase 1
Clinical Trials (1)
NCT01682538Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension
Phase 1
Palifermin 6 x 60 μg/kg/day
Leukemia
Phase 1
Phase 1
Clinical Trials (1)
NCT01734889Taste and Palatability of Orfadin Suspension
Phase 1
SOBI002
Healthy
Phase 1
Clinical Trials (1)
NCT02083666Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration
Phase 1
Phase 1
Clinical Trials (1)
NCT04691765Anakinra in Previously Untreated Chronic Lymphocytic Leukemia Patients
Phase 1
Efanesoctocog alfa
Hemophilia A
Phase 1
Clinical Trials (1)
NCT06579144Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A
Phase 1
Nitisinone 20 mg
Healthy
Phase 1
Clinical Trials (1)
NCT01857362Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.
Phase 1
Palifermin
Leukemia
Phase 1
Clinical Trials (1)
NCT00460421A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT
Phase 1
Nascobal nasal spray
Focus: Bioavailability
Phase 1
Clinical Trials (1)
NCT01306123Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration
Phase 1
Phase 1
Clinical Trials (1)
NCT01459562First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers
Phase 1
Phase 1
Clinical Trials (1)
NCT06538181Pacritinib in Vacuoles, E1 Ubiqutin-activating Enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) Syndrome
Phase 1
Phase 1/2
Clinical Trials (1)
NCT02037347Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis
Phase 1/2
Phase 1/2
Placebo
Mucositis
Phase 1/2
Phase 1/2
Clinical Trials (1)
NCT03811028A Study to Assess the Safety, Tolerability, and Efficacy of Long-term SOBI003 Treatment in Pediatric MPS IIIA Patients
Phase 1/2
Phase 1/2
Clinical Trials (1)
NCT03423186A Study to Assess the Safety and Tolerability of SOBI003 in Pediatric MPS IIIA Patients
Phase 1/2
Phase 1/2
Clinical Trials (1)
NCT04018755Open-label Study of Anakinra in MPS III
Phase 1/2

Open Jobs (0)

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

Interview Prep Quick Facts
Portfolio: 5 approved products, 44 clinical trials
Top TAs: Metabolic Diseases, Dermatology, Immunology
Portfolio Health
Peak1 (20%)
LOE Approaching4 (80%)
5 total products
Therapeutic Area Focus
Dermatology
1 marketed
Immunology
1 marketed
Respiratory
1 marketed
Marketed
Pipeline