Horizon Therapeutics has submitted a planning application to expand its development and manufacturing facility in Waterford, Ireland to add new drug substance biologics development and manufacturing capabilities. The planned facility would expand Horizon’s footprint, adding approximately 320,000 square feet to its current 44,000 square foot drug product (fill-finish) biologics facility, and would create approximately 350 jobs over time. Horizon anticipates providing additional details with respect to potential investment and timeline as the planning application process proceeds.

Horizon purchased its existing facility in June 2021 for $65 million with the understanding that adjacent Industrial Development Agency (IDA) Ireland land was available for further manufacturing and development expansion. Horizon continues to work with Ireland’s Health Products Regulatory Authority (HPRA) and the U.S. Food and Drug Administration (FDA) to obtain HPRA and FDA licensure for sterile fill-finish manufacturing and anticipates the first medicine approved for release from the existing facility in 2023. Both facilities are expected to be used for Horizon’s on market rare disease biologics as well as development-stage medicines.

“As we grow as a global biotechnology company, it is important to continue to invest in our development and manufacturing capabilities to supplement our current network of contract manufacturing organizations to maintain flexibility over our production and supply,” said Tim Walbert, chairman, president and CEO, Horizon. “The planned expansion to add this drug substance facility is important to the long-term growth of our commercial and pipeline biologics as well as our commitment to Ireland.”