Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion, licensing European production of Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] and Gammagard Liquid 10% [Immune Globulin Infusion (Human)] (marketed as Kiovig in the EU) through Baxalta’s manufacturing services agreement with Stichting Sanquin Bloedvoorziening (Sanquin Blood Supply Foundation or Sanquin) in the Netherlands. Both products are indicated to treat specific types of patients with primary immune deficiency.

Baxalta continues to optimize its manufacturing network to support increasing global demand for plasma–based therapies. The positive opinion from CHMP allows Sanquin to process plasma supplied by Baxalta into bulk material for Hyqvia and Gammagard Liquid 10% in the European markets. These additional manufacturing capabilities also allow Baxalta to optimize capacity at other facilities to serve other regions. Baxalta will continue to supply the US market from its US Food and Drug Administration (FDA) approved manufacturing sites in the US, Austria and Italy.

“Meeting the increasing demand for plasma-based therapies is a key component of our global manufacturing strategy,” said John Furey, senior vice president and head of Global Operations, Baxalta. “This CHMP positive opinion enables Baxalta to provide additional supply of critical plasma-based therapies by leveraging our manufacturing network and regional partners to optimize our flexibility and capacity.”

Previously, as Baxter International Inc.’s BioScience business, Baxalta entered into a manufacturing services agreement with Sanquin in July 2012. The agreement enables Baxalta to gradually ramp up to 1.6 million liters of incremental plasma fractionation capacity annually to support global growth of plasma-based treatments.