The new facility will add about 30 percent more capacity to Shire’s internal network.
Shire filed its first submission to the U.S. Food and Drug Administration (FDA) for its new plasma manufacturing site in Covington, Georgia.
The submission is for the transfer of GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% solution, which is a replacement therapeutic for primary humoral immunodeficiency (PI). It expects to make a second submission in 2018 for its albumin therapy. This therapy is mostly used in immune disorders, trauma and other conditions to replace and increase plasma volume.
The new facility will add about 30 percent more capacity to Shire’s internal network. Commercial manufacturing will begin in 2018.
“We are pleased to have filed the Georgia site and look forward to working with the FDA to seek approval for manufacturing in 2018,” said Matt Walker, Shire’s Head of Technical Operations, in a statement.
The Covington, Georgia locations employs about 900 full-time people. It expects to increase hiring for the facility in 2018, including manufacturing, quality, engineering, maintenance, utilities, warehouse and other support roles.
Because of a greater than 21 percent increase in immunology sales, Shire plans to continue to expand its plasma collection network in Georgia and throughout the U.S. through its subsidiary, BioLife Plasma Services.
Earlier this month, Shire announced topline results from its Phase II/III clinical trial of SHP609 for pediatric patients with Hunter syndrome (mucopolysaccharidosis II or MPH II) and cognitive impairment. The trial didn’t meet its primary or key secondary endpoint. The primary endpoint was the difference in cognition between the SHP609-treated and control groups. The secondary endpoint was the difference between the SHP609-treated and control groups.
“Shire is disappointed that the top-line data from this study did not meet the primary and key secondary endpoints and remains committed to patients and families living with MPS II,” said Howard Mayer, senior vice president and global head of R&D for Shire. “We are grateful to the children, their families and healthcare providers for participating in this challenging trial and will continue our ongoing dialogue with the community as we conduct an analysis of the full data set. Further analysis of the data will be presented at forthcoming congresses.”
Hunter syndrome affects about 1 in 162,000 live births, almost all males. It is a rare lysosomal storage disorder caused by a deficiency of iduronate-2 sulfatase. This enzyme breaks down glycosaminoglycans (GAGs). Without the enzyme, GAGs build up and damage organs, causing numerous disease-related symptoms, including hearing loss, reduced cardiac function, obstructive airway disease, enlarged liver and spleen, and creased range of motion and mobility. Other symptoms may include distinct facial features, a large head and enlarged abdomen. Often the central nervous system is affected.
“Hunter syndrome is a severely debilitating rare genetic disorder caused by an enzyme deficiency which typically presents in early childhood,” said Joseph Muenzer, professor of Pediatric Genetics and Metabolism Genetics at the University of North Carolina Chapel Hill School of Medicine, in a statement. “Two out of three patients exhibit progressive cognitive decline which is a high unmet need. This can be devastating for patients and their families as it severely diminishes a child’s functional ability and typically leads to death in the teenage years.”
