Tuesday, May 02, 2017
GSK announced $139 million of new investment in its biopharmaceutical manufacturing site in Rockville, MD to support growing demand for BENLYSTA® (belimumab) for adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.
The Rockville site is also expected to house production of a new subcutaneous form of belimumab which is currently under review with the FDA.
The $139 million investment will be used to provide additional internal capacity to increase bulk drug substance production by close to 50% at the Rockville site, to respond to increased demand.
"Benlysta is the first medicine specifically developed and approved for SLE in over 50 years. We are so pleased that on the first day of Lupus Awareness Month we are able to announce this expansion in Rockville, increasing our ability to provide this important medicine to patients," said Sheri Mullen, VP Immunology & Rare Diseases, GSK.
Benlysta continues to be a growing product for GSK. Since 2014, the product has grown at least 18% per year in the US on a constant exchange rate basis. In 2016, the company reported $377million in BENLYSTA sales in the US.
GSK announced regulatory filings for a 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 anywhere in the world.
The Rockville biopharmaceutical manufacturing site consists of two FDA-licensed facilities for large and small scale manufacturing, which employ more than 400 highly-skilled scientists, engineers and manufacturing and quality professionals among other specialists.
Today's announcement is the latest investment in the US that GSK has made following: