IDA Ireland business park, Waterford
Reaching an agreement with EirGen Pharma - an OPKO Health Company - Horizon Therapeutics has reached an agreement with the medical company to purchase one of its drug product manufacturing facilities, located at the IDA Ireland Business Park.
The facility includes a filling line and lyophiliser (freeze dryer), which Horizon Therapeutics will use for its commercial medicines for rare disease biologics - TEPEZZA, KRYSTEXXA, and UPLIZNA - as well as its development compounds.
Working with Ireland’s Health Product Regulatory Agency (HPRA) and the US Food and Drug Administration (FDA)
Looking to gain approval for the release of its first medicine in two years, Horizon Therapeutics will work with Ireland’s Health Product Regulatory Agency (HPRA) and the US Food and Drug Administration (FDA) to obtain HPRA and FDA licensure for sterile fill-finish manufacturing.
As part of the agreement between Horizon Therapeutics and EirGen Pharma, 40 employees from EirGen Pharma will transfer to Horizon Therapeutics, with plans to recruit 50 additional staff between 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. 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,” said Tim Walbert, chairman, president and chief executive officer, Horizon.
“This is very welcome news. 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,” said Leo Varadkar TD, Tanaiste (Deputy Prime Minister) and Minister for Enterprise, Trade and Employment in Ireland.
Additional Terms of the Agreement
As part of the terms of the agreement, Horizon Therapeutics will acquire the facility from EirGen Pharma for US$65mn in an upfront cash payment and is subject to customary closing conditions.
Expected to close in the third quarter of 2021, the site also has adjacent IDA land available for further manufacturing and development expansion plans for Horizon Therapeutics.
“Horizon is one of the next [generations] 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.