Pharma Focus Europe

Horizon Therapeutics plc Announces Plans to Expand its Development and Manufacturing Facility in Waterford, Ireland

Tuesday, August 30, 2022

Horizon Therapeutics plc has announced the submission of a planning application to expand its development and manufacturing facility in Waterford, Ireland. The expansion aims to include new capabilities for drug substance biologics development and manufacturing. The planned facility will significantly increase Horizon's footprint, adding approximately 320,000 square feet to its existing 44,000 square foot drug product (fill-finish) biologics facility. This expansion is expected to create around 350 jobs over time. Horizon plans to share more details regarding the investment and timeline as the planning application process progresses.

In June 2021, Horizon acquired its current facility for $65 million, with the knowledge that adjacent land owned by the Industrial Development Agency (IDA) Ireland was available for further expansion of manufacturing and development operations. Horizon is actively collaborating with Ireland's Health Products Regulatory Authority (HPRA) and the U.S. Food and Drug Administration (FDA) to obtain licensure from both regulatory bodies for sterile fill-finish manufacturing. The company expects the first medicine to be approved for release from the existing facility in 2023. Both the existing and planned facilities will be utilized for Horizon's rare disease biologics already on the market, as well as for the development of future medicines.

Tim Walbert, Chairman, President, and CEO of Horizon, emphasized the importance of investing in development and manufacturing capabilities as the company expands globally. He highlighted the need to supplement their existing network of contract manufacturing organizations to maintain flexibility in production and supply. The planned expansion to include a drug substance facility is a significant step toward the long-term growth of Horizon's commercial and pipeline biologics, demonstrating their commitment to Ireland.

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