July 24, 2016 7:11 PM ET

Biotechnology

Company Overview of Bio Products Laboratory Ltd.

Company Overview

Bio Products Laboratory Ltd. processes and manufactures plasma-derived products for healthcare professionals and patients in the United Kingdom and internationally. It offers human coagulation factors, immunoglobulins, and albumin solutions. The company also produces a small volume of products (on request) for niche markets. Bio Products Laboratory Ltd. was founded in 1950 and is based in Elstree, United Kingdom with operations in Durham, North Carolina.

Dagger Lane

Elstree,  WD6 3BX

United Kingdom

Founded in 1950

Phone:

44 20 8957 2200

Fax:

44 20 8957 2601

Key Executives for Bio Products Laboratory Ltd.

Chief Executive Officer
Age: 45
Chief Operating Officer
Medical Director
Vice President of Global Medical
Compensation as of Fiscal Year 2016.

Bio Products Laboratory Ltd. Key Developments

Bio Products Laboratory Ltd. Wins Multiple Awardees Contract for Supplying Factor X and Porcine Factor VIII

Bio Products Laboratory Ltd. won a multiple awardees contract award from The Secretary of State for Health acting as part of the Crown through the Commercial Medicines Unit (part of the Department of Health) for the supply of Factor X and Porcine Factor VIII (Contract Award Notice No.: 2016/S 108-193273). The lowest offer is GBP 14.4 million and the highest offer is GBP 17.6 million (excluding VAT).

Bio Products Laboratory, Ltd Announces FDA Submission of Biologics License Supplement for Gammaplex 10%

Bio Products Laboratory, Limited announced the submission of a Biologics License Supplement to the U.S. Food and Drug Administration for the use of Gammaplex 10%, Immune Globulin Intravenous (Human) in patients with primary immunodeficiencies. The application is based on a two-phase, crossover bioequivalence study between the 10% immune globulin treatment being investigated and the company’s approved immunoglobulin treatment, Gammaplex 5%, and was submitted on April 8, 2016. The study marks the first time that a 5% and a 10% immune globulin therapy have been directly compared in a registration trial in patients with primary immunodeficiencies. Gammaplex 10% is currently under review by the FDA, and not yet available in the US. Primary immunodeficiencies are a constellation of immune disorders that can negatively impact the body’s ability to fight infection. In some primary immunodeficiencies, the immune system does not manufacture adequate quantities of antibodies such as immune globulin G. Gammaplex 5% is indicated for replacement therapy in patients with primary immunodeficiencies. This indication includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott Aldrich syndrome, and severe combined immunodeficiencies.

Bio Products Laboratory Receives European Approval for Coagadex® (Human Coagulation Factor X)

Bio Products Laboratory Ltd. announced that the European Medicines Agency has granted marketing authorisation for Coagadex. Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency. Coagadex is the first and only treatment licensed specifically for this rare bleeding disorder in Europe. Factor X deficiency is a rare and serious condition caused by not having enough of the Factor X protein in the blood; this protein plays a crucial role in coagulation (blood clotting) which helps patients stop bleeding. People with Factor X deficiency are at increased risk of bleeding or experience excessive or prolonged bleeding. Severely affected individuals, usually children, have an increased risk of bleeding inside the brain, in the lungs or in the gastrointestinal tract, which can be life-threatening. Hereditary Factor X deficiency is very rare and affects approximately 700 patients in Europe. Coagadex was approved based upon data generated from two open-label, multicentre, 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 nd the number of infusions needed to treat a bleed.

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