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

Rhea-AI Summary

Horizon Therapeutics has submitted a planning application to expand its manufacturing facility in Waterford, Ireland, adding approximately 320,000 square feet to its current 44,000-square-foot drug product facility. This expansion aims to create around 350 jobs over time and enhance Horizons' drug substance biologics capabilities. Horizon is collaborating with the Health Products Regulatory Authority and the U.S. Food and Drug Administration for licensure of sterile fill-finish manufacturing, with the first medicine expected to be approved from the existing facility in 2023.

Positive

• Expansion of manufacturing facility by 320,000 square feet, enhancing drug substance capabilities.
• Creation of approximately 350 jobs in Waterford, Ireland.
• First medicine approval expected in 2023, indicating growth potential.

Negative

• Risks and uncertainties associated with the planning application and regulatory approval processes could delay expansion.
• Potential for modifications in plans due to changes in circumstances during construction.

DUBLIN--(BUSINESS WIRE)-- 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.”

About Horizon

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220828005031/en/

Tina Ventura

Senior Vice President, Chief Investor Relations Officer

Investor-relations@horizontherapeutics.com

U.S. Media:

Geoff Curtis

Executive Vice President, Corporate Affairs & Chief Communications Officer

media@horizontherapeutics.com

Ireland Media:

Gordon MRM

Ray Gordon

ray@gordonmrm.ie

Source: Horizon Therapeutics plc

FAQ

What is Horizon Therapeutics' recent press release about?

Horizon Therapeutics announced a planning application to expand its manufacturing facility in Waterford, Ireland.

How much space will the new facility add to Horizon's existing plant?

The new facility will add approximately 320,000 square feet.

What impact will the expansion have on jobs?

The expansion is expected to create around 350 jobs over time.

When is the first medicine from Horizon's existing facility expected to be approved?

The first medicine is anticipated to be approved in 2023.

What regulatory bodies is Horizon working with for its facility expansion?

Horizon is working with the Health Products Regulatory Authority and the U.S. Food and Drug Administration.