BioMarin secures FDA approval for Ireland production facility

Dive Brief:

  • Rare disease drug developer BioMarin said Monday the Food and Drug Administration has approved its bulk biologics manufacturing plant in a town in Cork, Ireland, for the production and distribution of Vimizim (elosulfase alfa), a treatment for MPS IVA approved in 2014.
  • Vimizim is BioMarin's fastest-growing product, with sales rising by 45% year over year to $106 million in the first quarter.
  • Securing FDA approval for the Shanbally-based plant gives BioMarin a second manufacturing site, adding capacity while diversifying production risks, the company said.

Dive Insight:

BioMarin has plans to expand the Shanbally site further, with a larger warehouse, new office space and expanded utilities all in the cards.

The California biotech acquired the 200,000 square foot facility from Pifzer in 2011 and recently received a certification for the site from the Health Products Regulatory Authorities (working on behalf of the European Medicines Agency).

The FDA specifically OK'd the Shanbally site for production of a formulated bulk substance used in the final production of Vimizim, along with other activities such as QC testing, packaging and distribution.

With a license from the FDA, BioMarin is now cleared to distribute drug product manufactured at the site in the U.S.

"The Shanbally plant greatly expands our manufacturing capacity to accommodate our growing commercial portfolio and advancing clinical programs, as well as diversifies manufacturing risk associated by now having two licensed facilities," BioMarin CEO Jean-Jacques Bienaime said in a statement.

The drugmaker has a cGMP manufacturing facility already on line in Novato, California.

More flexibility and manufacturing capacity may be needed in the near future, though, as BioMarin recently won approval from both the FDA and the EMA for Brineura (cerliponase alfa), a treatment for a type of Batten disease. The therapy, administered intraventricularly into the cerebrospinal fluid, was made available in the U.S. starting in June.

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Filed Under: Manufacturing
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