Outside of vaccines, GlaxoSmithKline isn’t a major producer of biologics compared with some of its Big Pharma peers. But it has just signed a big deal to scale up manufacturing in the field.
The British pharma tapped South Korean CDMO Samsung Biologics in a deal worth more than $231 million to help it make biologic products over the next eight years. The manufacturing capacity Samsung offers will be flexible depending on GSK’s future needs, the company said Friday.
The deal will initially cover lupus drug Benlysta, with the first commercial supply expected in 2022. The pair intends to expand the pact to other GSK specialty-care products in the future.
A well-developed crystallization process can produce suitable particles that can facilitate consistent filtration, drying and formulation of the API and allow confident and reliable manufacturing of the final drug product, while avoiding unnecessary cost, risk and development delays.
GSK’s biologics stable is relatively thin right now. Besides Benlysta, which generated sales of £613 million ($747 million) last year, GSK’s other major biologic drug is asthma therapy Nucala, with 2019 sales of £768 million ($936 million). But neither of the two is a multibillion-dollar earner like Merck & Co.’s PD-1 king Keytruda or AbbVie’s Humira.
The company is facing a manufacturing bottleneck for one product outside of its pharmaceutical offerings. Shingles vaccine Shingrix has been a major driver of GSK’s growth. Its sales more than doubled year over year to hit £1.81 billion ($2.21 billion) in 2019, even as strong demand continues to outstrip supply.
But the company seems to be taking Shingrix’s manufacturing in its own hands, with a new facility—and capacity expansion—planned for 2024.
More biologics for Samsung manufacture could come from GSK’s cancer pipeline, which just got a major reinforcement from its $5.1 billion Tesaro buyout. Specifically, anti-BCMA antibody-drug conjugate belantamab mafodotin is under FDA priority review in relapsed or refractory multiple myeloma after showing it could shrink tumors in more than 30% of patients in a phase 2 study.
An application for PD-1 inhibitor dostarlimab for second-line treatment of endometrial cancer has also ben submitted to the FDA, after data from the Garnet trial showed it triggered a response in 42% of patients.
As for Samsung Biologics, the South Korean CDMO has been aggressively expanding its manufacturing footprint, having already invested $2.6 billion into three plants with combined capacity of 362,000 liters. Last year, its revenue jumped 30.9% to 701.6 billion won ($565 million).
The GSK pact comes on the heels of a $362 million order from Vir Biotechnology to help the U.S. biotech manufacture monoclonal antibodies to potentially treat COVID-19.