Horizon Therapeutics plc (Nasdaq: HZNP) today announced it 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 chief executive officer, 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.”
Horizon is a global biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: We apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.
Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the potential expansion of Horizon’s manufacturing facility, Horizon’s expected use of the facility, timelines for regulatory approvals and release of medicine from Horizon’s existing facility, and expectations regarding job creation as a result of the expanded facility. These forward-looking statements are based on Horizon’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the planning application and regulatory approval processes, changes in circumstances that could cause Horizon to modify its plans or actual uses of the facility, potential delays in the planning application, construction, validation or regulatory approval processes, and those risks detailed from time-to-time under the caption “Risk Factors” and elsewhere in Horizon’s filings and reports with the SEC. Horizon undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information.