Dive Brief:
- Rare disease biotech BioMarin will invest $43 million to further expand its manufacturing plant in County Cork, Ireland, adding drug product filling capabilities to help meet growing demand for its rare disease medicines.
- The project will create another 51 jobs at the site, which was opened in 2011. All told, BioMarin currently employs about 350 staff in County Cork and over 2,600 worldwide.
- BioMarin produces the active pharmaceutical ingredients for Vimizim and its second-newest drug Brineura at the Cork facility. The biotech also operates another manufacturing plant in Novato, California, where it makes four other of its medicines.
Dive Insight:
BioMarin currently markets seven approved drugs, an accomplishment few biotechs can match. While most of its medicines aren't big sellers — the best performing, Vimizim (elosulfase alfa), is pacing for about $1 billion in annual sales this year — revenues have steadily grown of late.
In order to meet that demand, BioMarin is expanding its manufacturing base and pouring more money into its Shanbally, County Cork plant.
The biotech bought the site in 2011 from Pfizer for $49 million and has since grown its footprint there, adding new offices and expanding a warehouse. A Bio-Assay laboratory is in the works, while the planned investment will bring in product filling capacity.
Shanbally is the bigger of BioMarin's two sites, covering about twice the square footage of its operations in Novato.
Brineura (cerliponase alfa), an enzyme replacement therapy for Batten disease, and Vimizim, for Morquio A syndrome, are currently made at Shanbally. Vialing and labeling, however, are performed by contract manufacturers, according to a recent regulatory filing from BioMarin.
Between Novato and Shanbally, the company believes it has enough capacity to support commercial demand for Brineura and Vimizim for the next 5 years.
Another manufacturing challenge is looming, however. BioMarin is currently testing a gene therapy for hemophilia A, called valoctocogene roxaparvovec, that requires specialized production capabilities.
Manufacturing for the gene therapy candidate will also take place in Novato, where BioMarin last year commissioned a commercial production facility capable of supporting demand from 2,000 patients per year.