Jazz Pharma chooses Ireland for first facility
pharmafile | February 17, 2014 | News story | Manufacturing and Production | API, Ireland, azur, jazz pharma
Jazz Pharmaceuticals will build its first in-house manufacturing facility in Ireland after years of relying on outsourcing to meet its production needs.
The speciality drugmaker is planning to build a 5,100 sq. m. manufacturing and development city in Monksland, County Roscommon, at a cost of between €45 million and €50 million, that when complete in 2016 could create around 50 jobs.
Attracted by Ireland’s tax-friendly business environment, Jazz has been domiciled in the country since 2012 when it acquired former Elan unit Azur Pharma for approximately $500 million.
The start of construction “marks a milestone for Jazz Pharmaceuticals as we break ground in Ireland and begin, for the first time, construction on a manufacturing and development facility,” said the firm’s chief executive Bruce Cozadd.
Jazz’s reliance on contract manufacturing and distribution has raised eyebrows in recent years, particularly as revenues have accelerated, with turnover expected to increase 50% in 2013 year-on-year to reach more than $900 million. The company wants to build its own capacity to reduce its reliance on third parties – many of whom are single-source suppliers – and reduce the risk of potential disruptions to supply.
One issue for the company has been securing quotas from the US Drug Enforcement Administration (DEA) for the active ingredient in its biggest-selling product Xyrem (sodium oxybate) for narcolepsy, which is controlled as a Schedule III compound.
Jazz’s sole-source contract manufacturer for sodium oxybate Siegfried has to request an allocation from the DEA, and in 2013 was only allocated a portion of what it asked for in the first instance. Subsequently an increase was associated that allowed its needs to be met, but the potential for interrupted supply is a worry, particularly as Jazz has limited ability to maintain back-up inventory.
The patent for Xyrem is under assault by Roxane Laboratories in the US, Jazz maintains it has protection out to 2019 and potentially 2024. Meanwhile, it is developing a next-generation, deuterated version of sodium oxybate which should enter the clinic later this year.
Meanwhile, Jazz’s acute lymphoblastic leukaemia therapy Erwinaze (asparaginase Erwinia chrysanthemi) is also growing fast with sales of around $175 million last year, but has been affected by manufacturing issues at producer Public Health England (PHE) that disrupted supplies in Europe, which may have affected its decision to set up in-house production.
The company is also in the process of changing its finished product manufacturer for painkiller Prialt (ziconotide).
Phil Taylor
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