Baxalta Receives CHMP Positive Opinion for Sanquin to Begin Production, Enhancing Global Supply of Plasma-Based Therapies


Sanquin is now licensed to produce bulk material for HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] and GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] (marketed as KIOVIG in the EU)* for the European Union, Iceland and Norway
Baxalta continues to optimize its manufacturing network to support increasing global demand for plasma–based therapies and ensure reliable supply to patients

BANNOCKBURN, Ill.--(BUSINESS WIRE)-- Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced today 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 U.S. market from its U.S. Food and Drug Administration (FDA) approved manufacturing sites in the U.S., 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.

*GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] is marketed as KIOVIG outside the United States and Canada.

Full prescribing information for HYQVIA



Full prescribing information for GAMMAGARD LIQUID (KIOVIG in the EU)



About Baxalta

Baxalta Incorporated (NYSE: BXLT) is a $6 billion global biopharmaceutical leader developing, manufacturing and commercializing therapies for orphan diseases and underserved conditions in hematology, oncology and immunology. Driven by passion to make a meaningful impact on patients' lives, Baxalta's broad and diverse pipeline includes biologics with novel mechanisms and advanced technology platforms such as gene therapy. The Baxalta Global Innovation and R&D Center is located in Cambridge, Massachusetts. Launched in 2015 following separation from Baxter International, Baxalta's heritage in biopharmaceuticals spans decades. Baxalta's therapies are available in more than 100 countries and it has advanced biological manufacturing operations across 12 facilities, including state-of-the-art recombinant production and plasma fractionation. Headquartered in Northern Illinois, Baxalta employs 16,000 employees worldwide.

About Sanquin

Sanquin Blood Supply is a not-for-profit organization, responsible for the blood supply in the Netherlands. Sanquin plays an important role in transfusion medicine. The organization collects blood and plasma, produces labile blood products, develops and produces pharmaceutical products, conducts scientific research and develops and performs a multitude of diagnostic services. Sanquin employs approximately 3,000 workers in the Netherlands.

Forward-Looking Statements

This release includes forward-looking statements concerning Baxalta's plasma-derived therapies and plans related to their supply. Such statements are made of the date that they were first issued and are based on current expectations, beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Baxalta's control and which could cause actual results to differ materially from those in the forward-looking statements, including the following: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; product quality, manufacturing or supply issues; patient safety issues; and other risks identified in Baxalta's filings with the Securities and Exchange Commission, all of which are available on Baxalta's website. Baxalta expressly disclaims any intent or obligation to update these forward-looking statements except as required by law.

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Source: Baxalta Incorporated

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Geoffrey Mogilner, 1-224-940-8619

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