GSK Singapore and Vir Biotechnology Announce Advance Purchase Agreement with the Government of Singapore for Monoclonal Antibody Sotrovimab (VIR-7831)

  • GSK Singapore has signed an Advance Purchase Agreement with the Government of Singapore for sotrovimab
  • Sotrovimab is currently undergoing review by the Singapore Health Sciences Authority (HSA) under the Pandemic Special Access Route (PSAR) for interim authorization
  • Announcement follows the emergency use authorization (EUA) granted to sotrovimab by the US Food and Drug Administration (FDA) and a positive scientific opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP)  

SINGAPORE, June 30, 2021 /PRNewswire/ -- GlaxoSmithKline Singapore and Vir Biotechnology announced an agreement with the Government of Singapore for the supply of sotrovimab, an investigational single-dose monoclonal antibody, for the treatment of patients with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19.

"We are proud to have entered into this agreement with Singapore to supply sotrovimab. This is another example of Singapore's role in the global innovation ecosystem and their commitment to invest in innovation," said Mike Crichton, SVP Specialty and Primary Care Therapy Area, GSK. "As variants continue to arise, vaccines together with the availability of safe and effective monoclonal antibody treatments have the potential to increase the chance of ending the pandemic. We're committed to partnering with the government of Singapore to make this important treatment option available to its citizens and to be part of its long-term solution to manage COVID-19."

"We are very pleased to be working with the Singapore government to ensure that patients who are ill with COVID-19 have access to the most recent therapeutic options," said Phil Pang, chief medical officer of Vir Biotechnology.  "Sotrovimab was designed from the beginning to combat COVID-19 as it evolved, and, based on our most recent in vitro data, we are heartened to see that it appears to retain activity against all circulating variants of concern."

GSK Singapore has submitted an application under the Pandemic Special Access Route (PSAR) for sotrovimab to the Health Sciences Authority of Singapore (HSA). Sotrovimab is currently undergoing regulatory review for interim authorization under the PSAR.

The PSAR application includes submission of data from an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which was stopped early by an independent data monitoring committee in March due to evidence of profound clinical efficacy. Results of the interim analysis, based on data from 583 randomised patients, demonstrated an 85% (p=0.002) reduction in hospitalisation or death in those receiving sotrovimab compared to placebo, the primary endpoint of the trial. The PSAR review will also consider the medicine's quality and safety data. COMET-ICE final results will be available later this year.

Preclinical data suggest sotrovimab targets a conserved epitope of the SARS-CoV-2 spike protein which is less likely to mutate over time. Data from several in vitro studies demonstrated that sotrovimab maintains activity against multiple circulating variants of concern, including the Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), and Delta (B.1.617.2) variants, based on in vitro data from live virus and pseudotyped virus assays. The clinical impact of these variants is not yet known.  Data collection and analysis is still ongoing.

On 26 May, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to sotrovimab. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion following the referral of sotrovimab to the CHMP under Article 5(3) of Regulation 726/2004. The CHMP opinion under Article 5(3) can now be considered by the national authorities in EU member states when taking evidence-based decisions on the early use of the medicine prior to marketing authorisation.

GSK and Vir are in discussions with other governments to explore similar supply agreements, as countries accelerate their vaccine and therapeutics programmes against COVID-19.

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GSK cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

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