This is the story of how 21st-century drug manufacturing came to a small city on Ireland’s west coast.
In 2009, Limerick was dealt a blow when Dell announced that it would shut down its manufacturing facility at Raheen Business Park, resulting in 1,900 job losses. But from Dell’s ashes came Regeneron, a US biotech that arrived on these shores in 2014, joining Limerick’s growing cluster of multinationals.
Dell’s Limerick site was perfect for what Regeneron vice-president Niall O’Leary called “box-in-a-box” development of a new biopharma manufacturing plant. The conveyor belts, computer manufacturing equipment and everything else within the dormant Dell building was ripped out, and Regeneron added tens of thousands of kilometres of piping, modular clean rooms and three 10,000-litre bioreactors for the manufacture of monoclonal antibodies that are genetically engineered to hit specific targets within the body.
“At peak, we probably had about 1,200 contractors here on site,” said O’Leary of the rejuvenation of the building in Regeneron’s image.
Today, merged and rebranded, Dell EMC has a continued presence in Limerick, but the tech scene has become overshadowed by life sciences giants Regeneron, Johnson & Johnson’s Vistakon and Stryker Corporation. The city and wider county is setting out a long-term plan for prosperity with Limerick Twenty Thirty, and there are more immediate development plans afoot.
“There’s a vibe to the city that wasn’t there when we got here first, so we’re delighted to have played a small part in that,” said O’Leary, reflecting on three years settling into his new home.
O’Leary hails from a farming background in Killarney. Following his biotech studies in Dublin City University, he spent more than 20 years working in biotech, pharma and medical device companies in the US, starting in Regeneron five-and-a-half years ago in New York. “Once I hit Regeneron, I was almost home,” he said.
And so it was that, after an off-hand question from his boss about whether he would head up an Irish operation if Regeneron ever made a move there, O’Leary found himself, a year later, fetching an Irish map from his office to show executive vice-president Daniel Van Plew exactly where Limerick is.
‘I don’t necessarily care that we’re the biggest. My goal is to be the best’
– NIALL O’LEARY
Regeneron now stakes its claim as the largest biotech in Ireland by capacity. In fact, it’s one of the largest biologics manufacturing sites in the world. However, O’Leary isn’t pitching ‘bigger is better’. “I don’t really necessarily care that we’re the biggest. My goal is to be the best,” he said.
Regeneron maintains a small corporate office of about 50 people in Dublin, but it’s the west coast that has won O’Leary over – and not solely because it brings him closer to his hometown. He believes that that they’ve laid a blueprint for what others can achieve outside of the capital. “I think a major player like ourselves coming in shows that it can be done and there are favourable tailwinds when you land here. And we couldn’t be happier.”
Why Limerick? “There’s the obvious factors that all companies will say and they’re all pretty much true,” O’Leary opened, before rattling off Limerick’s greatest selling points for a US multinational. First, Ireland itself is an English-speaking nation in the European Union with a highly educated population. Culturally, we are quite similar to the US and, from New York, there’s just a five-hour time difference. Specifically for Regeneron, there was the size of the Limerick site and its location 30 minutes from Shannon airport, which has direct flights to New York. Ireland is also a midway point for US executives linking into Regeneron’s partners, such as Bayer in Germany and Sanofi in France.
“It ticks a ton of boxes,” said O’Leary. “Probably the most favourable one is a very favourable business environment,” he added – and it’s not the corporation-friendly tax regime he is lauding. Instead, he credits the international work of IDA Ireland and, locally, Limerick City and County Council for their help in making this US giant feel at home on Ireland’s west coast.
“The IDA are second to none, and I truly mean that. Really experts in their field. I’ve been very impressed with them as an Irish man coming back from America. I’ve seen a couple of [international development agencies] and the IDA are exceptionally good.”
As well as winning the US team over, IDA and local government ensured there was follow-through with support on the ground. “It’s not like they drop you in here and they leave you alone. There’s continuous support,” he explained.
Challenges of scale
Of course, Ireland is by no means perfect, and a major sticking point for O’Leary is that we lack the kind of infrastructure needed to excel as a life sciences hub. Time to get to market, time to get to ports – that’s what makes a big difference to big business.
In the US, Regeneron’s corporate HQ is located just outside New York City in Tarrytown, while the manufacturing plant is upstate in Rensselaer, at a distance similar to that between Dublin and Limerick. Ireland needs to lay the groundwork to similarly spread multinational investment across the country.
Put simply, it’s technically possible – with, for example, a high-speed train – to connect Dublin with cities such as Limerick, Cork, Galway and Waterford in under an hour, and O’Leary believes we need infrastructure like this to compete.
“Ireland really needs to recognise that people outside of Ireland view this as a small island off the coast of Europe, and I think we should suddenly realise that we’re not necessarily regional, but it is Ireland Inc at its best,” he said.
‘There are no other companies of our size that have the same philosophy and culture as we do’
– NIALL O’LEARY
One of Regeneron’s biggest challenges is recruitment across an ever-growing skills gap. “The biologics industry has a hole that’s growing by approximately 40pc a year, so it’s essentially leaving the old pharma behind, and I think that’s fairly well known in industry,” said O’Leary.
In Ireland, Regeneron maintains its pipeline through good relationships with University of Limerick, Limerick Institute of Technology and University College Cork, as well as engaging with initiatives such as Limerick for Engineering and the encouragement of children in STEM and STEAM (science, technology, engineering, arts and maths) from an early age.
“We’ve nearly 600 employees with about 250 full-time contractors,” said O’Leary. “We’re starting our journey, so I expect that to be significantly higher. We’re going to scale up the plant as our business needs require.”
The cost of drugs
Drug manufacturing is a long-term game and, to stay ahead of the curve, efforts are being made by biotechs to mine the massive dataset that is the human genome, to find targets for specific diseases so they can then produce monoclonal antibodies that hit those targets in an idealistic fusion of biologics and tech. “The marriage of technology and biotech really is coming to the forefront,” said O’Leary.
The Regeneron facility in Limerick represents an investment “north of $250m”, not to mention significant operational costs. “Biologics manufacturing is not cheap, by any stretch of the imagination,” said O’Leary. In fact, Regeneron has poured about $1bn into the Limerick plant so far and has yet to make a dollar on anything produced there.
However, O’Leary expects the facility to be “full at the brim for a long time to come” thanks to a pipeline of products coming in from the US. “A lot of people talk about pipelines and then there are the companies with real pipelines, and I believe that we’re the latter,” he said, referring to “new exciting drugs coming out of New York” that will be manufactured in Limerick over time.
The drugs produced by Regeneron tackle a variety of problems. Their flagship product is Eylea, a treatment for age-related macular degeneration (AMD) and diabetic macular oedema (though, in Europe, it is sold under Bayer’s branding). Eylea stormed onto the scene in 2011, undercutting the price of a competitor AMD drug by Roche and taking over this sight-saving slice of the market.
More recently, Regeneron received a lot of attention for its atopic dermatitis treatment, Dupixent. Specifically, it was the price that captured headlines. At a list price of $37,000 a year, this drug is certainly not cheap. However, the current best-selling drugs of its ilk – Humira and Enbrel – are priced around the $50,000 mark.
Regeneron co-founder, chair and CEO Leonard Schleifer openly criticised his pharmaceutical peers over “ridiculous” drug prices at the Forbes Healthcare Summit last December, and he insists that, in the case of Dupixent, the price is both fair and cost-effective.
“Regeneron has never ever raised drug prices. You set a drug price at what you consider is fair to pay back your needs and you don’t raise prices. That’s unique and we’re leading on that,” said O’Leary, a devout follower of Schleifer’s philosophy, which is markedly unique in this industry.
Because of its reputation, Regeneron Limerick attracts visitors from other companies looking to find out how they operate and perhaps even adopt some of their systems. O’Leary tells them: “I can show you exactly what we’ve done but you won’t be able to copy it or duplicate it because of our internal culture. Everything is about the culture here at Regeneron.” And that culture, he says, is one of “science and excellence”.
“There are no other companies of our size that have the same philosophy and culture as we do. Not to knock them – let them do their own business and I’m fine with that. But that’s why I like Regeneron, and I think the people who work here and who agree with that philosophy really enjoy working at this company.”
O’Leary is definitely one of these employees and seems genuinely thrilled at the work his company produces. “These are the real-deal drugs. These are not the drugs that your grandmother was given. These are next-generation, 21st-century drugs.”
He proudly points to the company’s appearance as either number one or two on Science magazine’s list of top employers for the past six years, and is also effusively proud of the “world-class” industrial operations and product supply (IOPS) division that he leads.
“We have probably the best company in the world with respect to scientific research,” he said, citing a senior management team made up of scientists and MD-PhDs who are “all about science first”.
“I’m very proud to be working for a company which is high science, that’s at the cutting edge of fully human monoclonal antibodies and future proteins.”