Horizon Therapeutics plc Announces Purchase of Manufacturing Facility to Support Growth of On-Market Rare Disease and Pipeline Biologics

Horizon Therapeutics plc announced that it has reached an agreement to purchase a drug product manufacturing facility from EirGen Pharma, an OPKO Health Company (Nasdaq: OPK) in Waterford, Ireland. The facility, which is located in an IDA Ireland business park, includes a filling line and lyophiliser, or freeze dryer, that can be used for both Horizon’s commercial medicines, including its rare disease biologics TEPEZZA (teprotumumab-trbw), KRYSTEXXA (pegloticase injection) and UPLIZNA (inebilizumab-cdon), and its development compounds.

Horizon will work with Ireland’s Health Products Regulatory Agency (HPRA) and 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 in approximately two years. As part of the transaction, approximately 40 EirGen employees will transfer to Horizon following the close of the transaction. Horizon intends to recruit 50 additional staff for the site in 2021 and 2022.

“With the successful TEPEZZA launch, ongoing KRYSTEXXA growth and the growth of our marketed medicine portfolio and pipeline, it is the right time to add in-house manufacturing capabilities,” said Tim Walbert, chairman, president and chief executive officer, Horizon. “Adding to our strong network of contract manufacturing organizations, this facility will also play an important role in our global expansion. We look forward to leveraging our existing technical operations expertise in Ireland, along with the expertise of the EirGen employees, to build a robust and effective manufacturing operation that will enable us to meet the unmet needs of people impacted by rare diseases around the world.”

“This is very welcome news,” said Leo Varadkar TD, Tanaiste (Deputy Prime Minister) and Minister for Enterprise, Trade and Employment in Ireland. “The employment will be of significant benefit to Waterford and the broader South East Region. It’s great to see a company with an established presence expanding its Irish operations in a regional location. It demonstrates Horizon’s commitment to Ireland and will allow the company to avail of the rich talent pool in this sector in the region.”

“Horizon is one of the next generation of high-growth biotech companies and this substantial investment is another positive development in Ireland’s growing biopharma industry,” said IDA Ireland CEO Martin Shanahan.

Under the terms of the agreement, Horizon will acquire the facility for a $65 million upfront cash payment. In addition, there is adjacent IDA land available for further manufacturing and development expansion. The transaction, which is subject to customary closing conditions, is expected to close in the third quarter.

Horizon’s global headquarters have been in Dublin, Ireland since 2014 and the company is currently fitting out a new, 62,000 square foot headquarters facility at 70 St. Stephen’s Green.