GSK in $139-Million Manufacturing Expansion for Lupus DrugBy
GlaxoSmithKline (GSK) is investing $139 million in its biopharmaceutical manufacturing site in Rockville, Maryland to expand internal capacity for bulk drug substance production by close to 50%. The expansion will support growing demand for Benlysta (belimumab), GSK’s drug for treating active, autoantibody-positive, systemic lupus erythematosus (SLE). GSK reported 2016 US sales of $377 million for Benlysta, which has grown at least 18% per year since 2014 in the US on a constant exchange rate basis.
In addition to the bulk drug substance capacity expansion, the Rockville site is also expected to house production of a new subcutaneous form of belimumab, the active ingredient in Benlysta, which is currently under review with the US Food and Drug Administration (FDA). GSK announced regulatory filings for the subcutaneous (self-injectable) formulation of belimumab, currently available as an intravenous formulation, in Europe and the US in 2016 and is expecting to hear from regulatory bodies in the second half of 2017. The subcutaneous formulation of belimumab is currently not approved for use.
GSK gained the Rockville site, the former headquarters of Human Genome Sciences (HGS), when it acquired HGS in 2012 for $3.6 billion. Prior to the acquisition, GSK and HGS had a collaboration, formed in 2006, to co-develop and co-commercialize Benlysta, which was approved by the FDA in March 2011. Under the collaboration, HGS was responsible for conducting Phase III trials, with assistance from GSK, and both companies shared equally in Phase III/Phase IV development costs, sales and marketing expenses, and profits of any product commercialized under the agreement.
The $139-million investment in the Rockville site is the latest GSK has announced recently. In December 2014, it announced a $245-million investment to transform its Upper Providence, Pennsylvania site into one of two major research and development (R&D) hubs for GSK globally. In December 2016, GSK announced a $50 million investment over the course of two years to continue developing its global vaccines R&D headquarters in Rockville, which opened in December 2016.