Shire hopes to get green light for US Flexbumin manufacture

Shire on Thursday filed a submission to the US food and drug administration to gain approval to manufacture Flexbumin at its new facility in the state of Georgia.

The treatment restores and maintains the volume of a patient’s blood and contains human albumin, a common component of blood plasma, and is a plasma-volume replacement therapy for patients with immune disorders, trauma, and other conditions.

The product is sold through the biopharmaceutical company’s immunology franchise, which the company said has experienced "strong demand" following a 13% increase in second quarter product sales compared to the prior year.

Matt Walker, head of technical operations for Shire, said: “We are very pleased to file this second submission for our state-of-the-art manufacturing facility in Georgia, after the facility received FDA approval earlier this year.”

The first submission approved for the site was an application for the manufacture of Gammaguard Liquid, which is used to treat primary immunodeficiency, and to reduce the risk of infection in individuals with poorly functioning immune systems such as those with chronic lymphocytic leukemia.

“Expanding our capacity for manufacturing Flexbumin will allow us to better meet the increasing global demand for plasma protein therapies and further supports our growing immunoglobulin and bio-therapeutics portfolio by enabling us to deliver these important treatments to our patients,” said Walker.

The London-listed company said it plans to continue expanding its plasma collection network in Georgia and throughout the US through subsidiary BioLife Plasma Services, which collects human plasma used in the manufacturing process for immunology products at the Georgia facility.

Shire’s shares were down 1.05% at 4,437.00p at 1648 BST.