A leading US biopharma company will run clinical trials in Ireland for a new drug it hopes will provide a breakthrough for an aggravating skin condition.
Fast-growing Regeneron, started in 1988, is still managed by its founders and has a broad range of targets, both with drugs already on the market and those coming through its pipeline.
Its flagship product is ophthamology drug Eylea, which treats wet age-related macular degeneration. More recently, it has brought “bad” cholesterol drug Praluent to market. It also markets Arcalyst, a gout therapy. In the pipeline are drugs for rheumatoid arthritis, skin diseases, pain and cancer.
All this is managed from the company's Tarrytown base in New York but most of Regeneron's major drug programmes are run with partners – Germany's Bayer in the case of Eylea and French drug giant Sanofi for Praluent and a number of late-stage pipeline candidates.
These European connections mean EU approval is often a first step for Regeneron’s drugs and were key factors behind the decision in early 2013 to open European headquarters in Dublin.
Focused Dublin team
Ireland features strongly on Regeneron’s radar. The company employs 300 people at its sole ex-US manufacturing facility in
, with another 200 jobs announced last year as the facility ramps up to full production.
Jeff Landry, who runs the European headquarters, says Dublin is "a very different venture and one that is important for the company as we expand our global footprint".
Landry is building a tightly focused cross-functional team out of Dublin that can deal with issues ranging from regulatory affairs to clinical operations and procurement as well as management of the company’s external supply-chain, contract manufacturers.
Leaders have now been put in place for these teams – including ex-Elan regulatory affairs director Muriel O'Byrne, who also worked in that area with AstraZeneca and GSK, and Brigitta Lassen Rossau, hired from Takeda's Copenhagen base to run the clinical research and operations management side.
Staffing in Dublin has doubled in the past year as these leaders expand operations and the company is still recruiting, having taken extra space at its Harcourt Street base in the city.
Expansion includes development of a drug called Dupilumab, for atopic dermatitis, an eczema-type condition for which there is no treatment apart from ointments that reduce symptoms. Being developed with Sanofi, the drug is heading for Phase III clinical trials.
Early clinical results give the company optimism. “The early results have been overwhelming”, with patient testimonies pointing to “remarkable results in a short time”.
“So that’s one that we want to get to the market sooner. We are fortunate to have FDA breakthrough designation in the US on that,” says Landry.
“We are preparing to have trials here in Ireland that will begin hopefully this summer with Irish patients enrolled in the trials and on the drug.”
For a country with such a large pharmaceuticals sector, Ireland does not have a strong history of involvement in clinical trials, despite the presence here of two listed trials groups – Icon and Venn Life Sciences.
Partly, that’s down to numbers. A smaller population compared to some European neighbours means it is less likely there will be sufficient numbers here for large-scale trials.
But Landry says the company was approached by physicians working with patients with atopic dermatitis in Ireland .
“We hope maybe that can set a bit of a future trend with these initial sites that plan to go live later this year and that others in the medical field follow a similar approach,” he says.
R&D tends to be concentrated in New York but Landry says the company is exploring the potential for collaborations in Ireland with company researchers having met colleagues at Trinity College and UCD, as well as Science Foundation Ireland chief Prof Mark Ferguson.
The Dublin base gives it insight into the European market, Landry says. Having team leaders in Dublin “closely interacting with New York and our European partner . . . having people on the ground with a knowledge of developments in a rapidly changing and complex landscape” is of “tremendous value”.
Having lost a key patent dispute this month with rival Amgen on the cholesterol drug Praluent, delivering on the expectations for its late-stage pipeline will become increasingly important for Regeneron. The expansion of roles for Landry and the growing EU headquarters point to the importance of the Dublin operation in the company’s plans.