Pharma COVID Roundup: News from AstraZeneca, Gilead, and GSK
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from AstraZeneca, Gilead, GSK, Vir, Novavax, Celltrion, and Thermo Fisher Scientific.
Manufacturing and supply of COVID-19 vaccines and drugs
Court Rules on Supply of AstraZeneca’s COVID-19 Vaccine to the EU
In a case brought against AstraZeneca by the European Commission (EC) and the 27 member states of the European Union (EU), the Court of First Instance of Brussels has ordered AstraZeneca to deliver a total of 80.2 million doses of its COVID-19 vaccine to the EU by the end of September (September 2021), which includes 50 million doses of its COVID-19 vaccine in July, August and September.
The court’s ruling on vaccine delivery was less than the EC had been seeking. The EC was seeking delivery of 120 million doses cumulatively by the end of June 2021 and a total of 300 million doses by the end of September 2021.
According to a binding schedule from the court, AstraZeneca is ordered to deliver 15 million doses by July 26, 2021; 20 million doses by August 23, 2021; and 15 million doses by September 27, 2021. In the event of non-compliance with these delivery deadlines, AstraZeneca will have to pay a penalty of EUR 10 ($12) per dose not delivered. Taken with previous doses delivered, this brings the total number of doses ordered by the court for AstraZeneca to deliver to the EU from the time the contract was agreed to through September 27, 2021 to 80.2 million doses.
To date (as reported on June 18, 2021), AstraZeneca says it has supplied more than 70 million doses to the EU and says it will exceed 80.2 million doses by the end of June (June 2021).
In addition, AstraZeneca said the court, in making its ruling, “also acknowledged that the difficulties experienced by AstraZeneca in this unprecedented situation had a substantial impact on the delay.” Also, in its ruling, the court ruled that all other measures sought by the EC have been dismissed. In particular, the court found that the EC has no exclusivity or right of priority over all other contracting parties.
AstraZeneca says it continues to engage with governments, international organizations, and collaborators globally to ensure broad and equitable access to its COVID-19 vaccine at no profit during the pandemic period.
Source: AstraZeneca and the European Commission
Canadian Mfg Center Completed for Novavax COVID-19 Vaccine
As part of a partnership with the Canadian government, Novavax, a Gaithersburg, Maryland vaccine company, reports that construction of the new Biologics Manufacturing Center (BMC) at the National Research Council (NRC) of Canada in Montréal, Québec has been completed to support production of its COVID-19 vaccine.
The BMC will support production of NVX-CoV2373, Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine candidate, once the facility and vaccine receive the required Health Canada approvals. Novavax and the NRC are working together on technology transfer to establish the production process for NVX-CoV2373 at the BMC.
In February (February 2021), Novavax signed a memorandum of understanding with the Canadian government to produce its COVID-19 vaccine candidate at the BMC. In March (March 2021), Novavax signed a collaboration agreement with the NRC to enable technology transfer.
Source: Novavax
Updates on COVID-19 treatments and vaccines
Gilead’s Veklury Shows Positive Results Real-World COVID-19 Study
Gilead Sciences reports positive results from three retrospective studies of real-world data evaluating patients hospitalized with COVID-19 with Veklury (remdesivir), its antiviral drug for treating COVID-19.
All three of the real-world analyses observed that in the overall patient populations, patients who received Veklury had lower risk for mortality compared with matched controls. Two of the studies also observed that patients who received Veklury had an increased likelihood of discharge from the hospital by Day 28 of treatment.
In the US, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for treating COVID-19 requiring hospitalization.
Source: Gilead Sciences
GSK, Vir Report Positive Results for COVID-19 Drug; Update Mfg Plan
GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based clinical-stage bio/pharmaceutical company, report positive final confirmatory results from a Phase III trial evaluating sotrovimab, a monoclonal antibody for treating adults and adolescents with COVID-19.
The companies report that the trial demonstrated that sotrovimab reduced the risk of hospitalization or death among high-risk adult outpatients with mild-to-moderate COVID-19.
Additionally, the US National Institutes of Health updated its COVID-19 treatment guidelines to recommend sotrovimab for non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk of clinical progression and noted that sotrovimab appears to retain activity against current variants of concern and interest.
GSK and Vir plan to submit a biologics license application to the US Food and Drug Administration (FDA) in the second half of 2021. The European Medicines Agency has started a rolling review of data on sotrovimab that will continue until enough evidence is available to support the filing of a formal marketing authorization application.
Additionally, the companies’ manufacturing network is enabling the manufacture of approximately two million doses to support emergency supply in the first year following FDA’s emergency use authorization, with approximately 450,000 doses on hand.
Source: GlaxoSmithKline and Vir Biotechnology
Celltrion Reports Interim Results for COVID-19 Drug
Celltrion, an Incheon, South Korea, bio/pharmaceutical company, reports that regdanvimab, its COVID-19 drug candidate, met all primary and key secondary endpoints in a Phase III study of patients with mild- to- moderate symptoms of COVID-19. The company anticipates full Phase III data to be released in the coming months (as reported on June 14, 2021).
The company reported that regdanvimab reduced the risk of COVID-19-related hospitalization or death by 72% for patients at high risk of progressing to severe COVID-19 and 70% for all patients.
Source: Celltrion
News on COVID-19 testing
Thermo Fisher Launches COVID-19 PCR Combo Kit
Thermo Fisher Scientific has launched a new CE-IVD-marked COVID-19 test, the TaqPath COVID-19 Fast PCR Combo Kit 2.0, to expand the company’s tests that detect active SARS-CoV-2 infections. The CE Marking is required for in vitro diagnostic (IVD) devices sold in Europe.
The first-generation TaqPath COVID-19 CE-IVD RT PCR Kit and the TaqPath COVID-19 Combo Kit, which use a different assay design, respectively, received initial CE-IVD certification and emergency use authorization from the US Food and Drug Administration in March 2020.
Source: Thermo Fisher Scientific
