GSK invests $139M to boost lupus drug production
- GlaxoSmithKline will invest $139 million in its Rockville, Maryland manufacturing site, boosting production capacity for its lupus drug Benlysta (belimumab) in response to growing demand.
- The expansion should help increase bulk drug substance production by about 50%, as well as prepare for manufacturing of an experimental subcutaneous form of Benlysta currently under review by the Food and Drug Administration.
- Approvals in the U.S. and Europe for the new formulation are expected in the second half of 2017, potentially adding a more convenient treatment option for patients.
While Benlysta revenues are still a relatively small line item for the British drugmaker, the drug has seen steady growth in recent years.
Sales of Benlysta, which was the first new drug specifically approved for the treatment of systemic lupus erythematosus in five decades, increased 22% in the first quarter over the same period last year. Last year the drug pulled in $377 million in U.S. sales, making it one of GlaxoSmithKline's top 10 products in that market.
Currently, most demand for Benlysta is in the U.S., accounting for over 90% of total sales.
Elsewhere, the drug has only marginal sales. In the U.K., Benlysta had a bit of a fight to get to market after a cost regulator initially rejected the drug over efficacy concerns. It was eventually approved in May, but remains under a managed access scheme.
The Benlysta expansion is the latest in a string of recent investments by the drugmaker in the U.S.
GlaxoSmithKline is currently in the midst of opening its new vaccines R&D center in Rockville, earmarking $50 million for site development over the next two years. And in December 2014, the company put up $245 million to make its Upper Providence, Pennsylvania site one of its two global R&D hubs.
- GlaxoSmithKline Press release
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