July 22, 2017 5:48 AM 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: 46
Chief Operating Officer
Medical Director
Vice President of Global Medical
Compensation as of Fiscal Year 2017.

Bio Products Laboratory Ltd. Key Developments

FDA Approves Bio Products Laboratory's Gammaplex® 10% for Treatment of Primary Immunodeficiency and Chronic Immune Thrombocytopenic Purpura

Bio Products Laboratory Limited announced that the U.S. Food and Drug Administration (FDA) has approved Gammaplex® 10% (immune globulin intravenous [human], 10% liquid) for the treatment of primary immunodeficiency (PI) and chronic immune thrombocytopenic purpura (ITP) in adults. Gammaplex 10% is made with the same process as BPL's previously approved intravenous immunoglobulin (IVIG) treatment, Gammaplex® 5% (immune globulin intravenous [human], 5% liquid). Gammaplex 10% is more concentrated than Gammaplex 5%, with an immune globulin G (IgG) concentration of 100g/L, and is stabilized with glycine. The approval was based on a two-phase, crossover bioequivalence study comparing Gammaplex 10% and Gammaplex 5% in 33 adult patients with PI. The primary endpoint of bioequivalence between the products was achieved and trough levels of IgG were well maintained throughout the study. This study is the first direct comparison of 10% and 5% IVIG products in the treatment of PI. In the study both Gammaplex 10% and Gammaplex 5% infusion rates were increased incrementally at 15-minute intervals if tolerated by the subject. No notable differences were observed in the safety and tolerability between the products and the Gammaplex 10% infusion rate was increased per the prescribed infusion schedule to maximum infusion rate in 96% of infusions. The mean infusion time for Gammaplex 10% in adult patients was 1 hour and 51 minutes, which was 57 minutes faster than Gammaplex 5%. The most common adverse reactions in adult subjects receiving Gammaplex 10% in the PI clinical trial were headache (12.5% of subjects), migraine (6.3%), and pyrexia (6.3%). There were no serious product-related adverse reactions in the PI clinical trial. The safety of Gammaplex 10% has not been established in patients with ITP. The safety profile for Gammaplex 5% has been studied in subjects with ITP, and it is anticipated that the safety profile for both formulations are comparable for ITP patients. The most common adverse reactions in adult subjects receiving Gammaplex 5% in the chronic ITP clinical trial were headache, vomiting, nausea, pyrexia, arthralgia, and dehydration. Serious adverse reactions observed in clinical trial subjects with ITP were headache, vomiting and dehydration. 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 IgG. Gammaplex 10% acts as replacement therapy in these patients.

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.

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