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DUBLIN–(BUSINESS WIRE)–Horizon Therapeutics plc (Nasdaq: HZNP) today announced that it has submitted a planning application to expand its development and manufacturing facility in Waterford, Ireland to add new capabilities development and manufacture of biological substances. The planned facility would expand Horizon’s footprint, adding approximately 320,000 square feet to its current 44,000 square foot pharmaceutical (fill-finish) facility, and create approximately 350 jobs over time. Horizon expects to provide additional details regarding potential investment and timing as the planning application process progresses.
Horizon purchased its existing facility in June 2021 for $65 million on the understanding that adjacent Industrial Development Agency (IDA) land in Ireland was available for further manufacturing and development expansion. Horizon continues to work with the Irish Health Products Regulatory Authority (HPRA) and the U.S. Food and Drug Administration (FDA) to obtain HPRA and FDA clearance for fill-finish manufacturing sterile and anticipates the first drug to be approved for release from the existing facility in 2023. Both facilities are expected to be used for Horizon’s marketed rare disease biologics as well as drugs in development.
“As we grow as a global biotechnology company, it is important to continue to invest in our development and manufacturing capabilities to complement our current network of contract manufacturing organizations to maintain our production flexibility and of our supply,” said Tim Walbert, President, President and CEO. 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.”
About Horizon
Horizon is a global biotechnology company focused on the discovery, development and commercialization of medicines that address the critical needs of people affected by rare, autoimmune and serious inflammatory diseases. Our pipeline is useful: 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 TwitterLinkedIn, Instagram and Facebook.
Forward-looking statements
This press release contains forward-looking statements, including, but not limited to, statements relating to the potential expansion of Horizon’s manufacturing facility, Horizon’s intended use of the facility, timelines for regulatory approvals and the release of drugs from Horizon’s existing facility, and expectations regarding job creation following the expansion of the 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 these forward-looking statements due to such risks and uncertainties, which include, but are not limited to, risks and uncertainties associated with the planning application and approval processes. regulatory requirements, changes in circumstances that could cause Horizon to alter its plans or actual uses of the facility, potential delays in the planning, construction, validation or regulatory approval application processes, and detailed risks of from time to time under “Risk Factors” and elsewhere in Horizon’s SEC Filings and Reports. Horizon assumes no obligation or obligation to update any forward-looking statements contained in this press release as a result of new information.
See the source version on businesswire.com: https://www.businesswire.com/news/home/20220828005031/en/
Tina Ventura
Senior Vice President, Director of Investor Relations
[email protected]
American media:
Geoff Curtis
Executive Vice President, Corporate Affairs and Head of Communications
[email protected]
Irish media:
Gordon M.R.M.
Ray Gordon
[email protected]
Source: Horizon Therapeutics plc
