Company Overview of Bio Products Laboratory Ltd
Bio Products Laboratory Ltd is engaged in the research and development, and manufacture of human blood plasma products. It offers normal intravenous immunoglobulin preparations for the treatment of patients who have no or very low levels of antibody production; products for primary and secondary immunodeficiency; idiopathic thrombocytopenic purpurafor; specific immunoglobulins; and products for Kawasaki disease. The company also provides products for Guillain-Barré Syndrome, a short-term inflammation of the nerves that control the arms and legs; Human Albumin that is used for the restoration and maintenance of circulating blood volume; and Factor VIII and Albumin products. It supply its plas...
Elstree, WD6 3BX
Founded in 1950
Key Executives for Bio Products Laboratory Ltd
Compensation as of Fiscal Year 2015.
Bio Products Laboratory Ltd Key Developments
Bio Products Laboratory Selects Soleo Health to Dispense Coagadex®
Oct 26 15
Soleo Health, Inc. announced that it has been selected by Bio Products Laboratory (BPL) to dispense Coagadex® (Coagulation Factor X, Human). On October 20, 2015, Coagadex was approved by the U.S. Food and Drug Administration for the treatment of adults and children (aged 12 years and above) with hereditary factor X deficiency for on-demand treatment and control of bleeding episodes, and perioperative management of bleeding in patients with mild hereditary factor X deficiency. Hereditary factor X deficiency is a rare bleeding disorder that affects approximately 300-600 patients in the U.S. Affected individuals often have inadequate amounts of circulating factor X, an important component of the coagulation system. Factor X deficient patients are at increased risk of bleeding and need to be managed similarly to hemophilia patients.
Bio Products Laboratory Ltd Receives FDA Approval for Coagadex® (Coagulation Factor X, Human)
Oct 21 15
Bio Products Laboratory Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Coagadex for the treatment of adults and children (aged 12 years and over) with hereditary factor X deficiency for on-demand treatment and control of bleeding episodes, and perioperative management of bleeding in patients with mild hereditary Factor X deficiency. Coagadex is the first and only FDA-approved product to treat hereditary factor X deficiency and is the only specific factor X concentrate available in the U.S. Coagadex is expected to be available to patients in the U.S. in December 2015 through a network of specialty pharmacies and authorized distributors. Hereditary factor X deficiency is a rare bleeding disorder that affects approximately 300-600 patients in the U.S. Affected individuals often have inadequate amounts of circulating factor X, an important component of the coagulation system. Factor X deficient patients are at increased risk of bleeding and need to be managed similarly to hemophilia patients. Coagadex was approved based upon data generated from two open-label, multicenter, prospective studies. The first study enrolled patients with moderate to severe hereditary factor X deficiency who were treated on-demand for spontaneous or traumatic bleeding episodes. The primary efficacy endpoints were pharmacokinetic measures including recovery rate and half-life, and secondary endpoints included overall assessment of efficacy and the number of infusions needed to treat a bleed.
Bio Products Laboratory, Limited Announces Enrollment of the First Subject in Phase III Clinical Trial to Evaluate New Subcutaneous Immunoglobulin Product for Patients with Primary Immunodeficiency
Sep 1 15
Bio Products Laboratory, Limited announced that the first subject has enrolled in SCIG03, a clinical trial evaluating the safety and pharmacokinetics of SubgamVF, 16% liquid immunoglobulin for the treatment of primary immunodeficiency. The trial, titled, 'A Phase III, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics and Safety of SubgamVF in Primary Immunodeficiency Diseases' (clinicaltrials.gov identifier, NCT01884311), will take place in the U.S. and will form the basis of a biologics license application for U.S. marketing authorization. The trial will enroll 35 patients with primary immunodeficiency and treat them for up to 26 weeks. The pharmacokinetics of SubgamVF will be assessed and will be compared to previous studies. Subgam-VF is a 16% immunoglobulin product made from human plasma specifically for subcutaneous use. The product is undergoing testing in the U.S. and has not been evaluated by the U.S. Food and Drug Administration.
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