GSK’s Covid-19 antibody drug to have mixed results for Samsung

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The FDA granted emergency use authorization (EUA) to VIR-7831 on Thursday to treat and prevent mild and moderate Covid-19 patients aged 12 or more and weighing at least 40 kg from advancing to a severe condition leading to death.

Local attention has since been drawn to the FDA move’s impact on the two large bio-industry companies -- Samsung Biologics and Celltrion.

Industry experts expected that the approval would benefit Samsung Biologics, as the company had signed a contract manufacturing organization (CMO) deal worth 439.4 billion won ($394 million) with GSK and Vir to produce and supply VIR-7831 to the two co-developers until 2022.

In contrast, the EUA will likely hurt Celltrion as it means that the company faces additional competition for its Covid-19 antibody treatment, Regkirona, in the U.S. market. The FDA approval is doubly soring for Celltrion, as GSK and Vir started developing the sotrovimab-based antibody treatment later than Celltrion's Regkirona but won the EUA ahead of the latter according to the industry watchers.

GSK and Vir winning the EUA approval, the U.S. now has three Covid-19 antibody treatments, including Eli Lilly's LY-CoV555+LY-CoV016 and Regeneron's REGN-COV2. Therefore, it is unclear how large Celltrion’s market share will be after acquiring the regulatory nod,” an industry executive said requesting anonymity for reason of privacy.

In the first quarter, Eli Lilly and Regeneron's antibody therapy sales were $810.1 million and $438.8 million, respectively.

According to U.S. media outlets, the GSK-Vir team plans to start the delivery of VIR-7831 in a few weeks.

Celltrion had expressed expectations of exporting its antibody treatment to the global market since the beginning of this year.

However, the company has yet to obtain approvals in two of the largest markets – U.S. and EU – after starting the procedure to receive EUA for Regkirona from the FDA and European Medicines Agency (EMA) earlier the year.

In the EU, the company has gained an EMA recommendation for use so that European countries urgently needing to use a treatment for Covid-19 had been able to introduce Regkirona before approval on March 26.

However, the result of the ongoing rolling review of Regkirona, which started on Feb. 24, will work as the basis for a full EU marketing permit, which means that the company's drug has yet to win a EUA.

GSK and Vir have also received a positive scientific opinion on VIR-7831 from the EMA’s Committee for Human Medical Products (CHMP) for the early treatment of Covid-19 on May 21.