Alexion Pharmaceutical’s lead product Soliris (eculizumab), a monoclonal antibody used to treat patients with the rare disease atypical Haemolytic Uraemic Syndrome (aHUS), is currently made at a plant in Rhode Island, and two plants operated by contract manufacturing organisation Lonza.
But the Connecticut-headquartered firm is now looking to expand its Irish network, pledging €450m for a new facility in Blanchardstown, Dublin, supporting a €75m new packaging and warehousing plant on the site which the firm began constructing last April.
The site will support the production and distribution of Soliris and Alexion’s biologics pipeline, the firm said, with a spokesman telling Biopharma-Reporter.com the site will not impact the ongoing partnership with Lonza.
“This development is a result of a strategic evaluation of Alexion’s manufacturing network which will result in manufacturing capacity being spread across current and future sites both within Alexion and our CMO platform including Lonza.”
Alexion’s first biologics manufacturing facility outside the US, when finished, will have multi-product capability and utilise a mix of technologies, we were told, and will include four 20,000 litre stainless steel bioreactors.
Manufacturing troubles
Soliris is one of the world’s most expensive drugs, costing patients around $440,000 a year in the US – approximately 20 times that of other monoclonal antibodies. In 2014, Alexion reported net sales of $2.2bn for the product, up 44% year-on-year.
However, Alexion has had trouble with manufacturing Soliris in the past: in March 2013 the Rhode Island facility was hit with a US FDA Warning Letter which has not been closed out, and the firm has initiated several recalls of the drug since.
“Since the 2013 Warning Letter at the Alexion Rhode Island facility – Alexion has worked diligently to address FDA concerns. Advancing quality and compliance initiatives is a key priority at Alexion,” the company told this publication.
The new facility will be supported by a fill/finish plant in Athlone, County Roscommon, which the company acquired last year from Irish drugmaker Alkermes for €55m, and will create an additional 200 full-time jobs on completion.
“This is one of the largest investments in healthcare in the history of the Irish state,” said Martin Shanahan, CEO of Ireland’s industrial development agency, IDA. “Putting an additional €450 million into a site is a real statement of intent from Alexion.”
Synageva Acquisition
The investment comes just a week after Alexion entered a definitive agreement to acquire Synageva BioPharma, a Massachusetts-based firm developing orphan biopharmaceuticals, for $8.4bn.
“Synageva is an ideal strategic and operational fit for Alexion that aligns with what we know well and do well -- providing life-transforming therapies to an increasing number of patients with devastating and rare diseases,” Alexion CEO David Hallal said.
“We are excited to create the most robust rare disease pipeline in biotech across a range of therapeutic modalities. Synageva is an outstanding company that shares Alexion’s commitment to serving patients with rare diseases, and together we will create increasing value for our stakeholders.”