Pharma COVID Roundup: News from J&J, GSK, Novavax, and CureVacBy
The latest on manufacturing, potential treatments, and testing for COVID-19 with news from J&J, GSK, Vir Biotechnology, Novavax, CureVac, Thermo Fisher, and BD.
Manufacturing and supply of COVID-19 vaccines and drugs
Novavax, SK Bioscience Expand Supply Pact for COVID Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, and SK Bioscience, a vaccine developer and manufacturer and part of the SK Group, have expanded their existing manufacturing partnership for Novavax’s COVID-19 vaccine, NVX-CoV2373, to increase production capacity and supply 40 million doses of the vaccine to South Korea.
In addition to the already existing manufacturing arrangement, SK Bioscience has obtained a license to manufacture and commercialize NVX-CoV2373 for sale to the Korean government. SK Bioscience will add production capacity under the new agreement. The agreement calls for technology transfer related to the manufacturing of Novavax’s protein antigen, supply of Novavax’s adjuvant (Matrix M), and support to SK Bioscience as needed to secure regulatory approval. Concurrently, SK Bioscience has finalized an advance purchase agreement with the Korean government to supply 40 million doses of NVX-CoV2373 to South Korea beginning in 2021.
The companies say technology transfer and production scale-up is progressing well under the previously announced collaboration for SK Bioscience to produce the protein antigen component of NVX-CoV2373 for Novavax, which Novavax expects to deliver to global markets, including the COVAX facility, a global initiative aimed at equitable access to COVID-19 vaccines.
Last month (January 2021), Novavax reported positive interim efficacy results for the vaccine candidate in an ongoing Phase III clinical trial in the UK and is also currently conducting a Phase III trial in the US and Mexico.
Updates on COVID-19 treatments and vaccines
J&J Files for EU Conditional Marketing Authorization for COVID Vaccine
Johnson & Johnson (J&J) has submitted a conditional marketing authorization (CMA) application to the European Medicines Agency (EMA) for its investigational single-dose COVID-19 vaccine.
In December 2020, J&J initiated a rolling submission with the EMA for the vaccine. Rolling submissions also have been initiated in several countries globally and with the World Health Organization. The company filed for emergency use authorization (EUA) in the US earlier this month (February 2021). An advisory committee of the US Food and Drug Administration has scheduled a meeting on February 26, 2021 to review the EUA request.
J&J’s COVID-19 vaccine uses the company’s AdVac vaccine platform, which was also used to develop and manufacture the company’s Ebola vaccine regimen, which was approved by the European Commission and to construct its investigational vaccines against Zika, respiratory syncytial virus, and HIV.
In separate news, the South African government reported it had received the first delivery of the J&J vaccine; 80,000 doses of vaccine are being prepared for distribution across South Africa. The vaccine was approved by South African Health Products Authority
Source: Johnson & Johnson, South African Government Communications, and the South African President’s Statement
GSK, Vir Expand COVID-19 Pact for Other Respiratory Viruses in $845-M Deal
GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based clinical-stage biopharmaceutical company, have signed a binding agreement to expand their existing COVID-19 collaboration to include the research and development of new therapies for influenza and other respiratory viruses, in a $845-million deal ($225 million upfront, an $120-million equity investment, and $500 million in potential milestones).
The expanded collaboration, which builds on the agreement signed in April 2020 to research and develop therapies for COVID-19, provides GSK exclusive rights to collaborate with Vir on the development of potential monoclonal antibodies (mAbs) for the prevention or treatment of influenza during g a three-year research period. These include: (1) VIR-2482, an intramuscularly administered investigational mAb designed as a prophylactic for influenza A, which has completed a Phase I trial; and (2) other antibodies for the prevention or treatment of influenza. GSK will have the exclusive option to co-develop VIR-2482 after Vir completes and reports Phase II trial outcomes and will share development costs on the development of all other influenza mAbs.
As part of the new collaboration agreement, the companies will also engage in two additional research programs. The first is an expansion of their current functional genomics collaboration to develop potential pan-coronavirus therapeutics to now include other respiratory virus targets. Under the second program, the companies will collaborate to develop up to three neutralizing mAbs identified using Vir’s antibody technology platform to target non-influenza pathogens during a three-year research period.
Under the agreement, GSK will make an upfront payment of $225 million, and a further equity investment in Vir of $120 million. Initially, Vir will continue to fund the development of VIR-2482 through completion of Phase II trials, after which, if GSK exercises its option to co-develop VIR-2482, it will pay an option fee of $300 million. Following option exercise for VIR-2482, and for each other program in the expanded collaboration, the companies will share the development costs and related profits associated with this agreement. GSK will also pay Vir up to $200 million based on the successful delivery of pre-defined regulatory milestones. The equity investment and collaboration agreement are conditional upon customary conditions including regulatory review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.
VIR-7832 has been accepted into the UK’s National Health Service-supported Phase Ib/IIa study with a planned start in February 2021 (as reported on February 17, 2021).
Source: GlaxoSmithKline and Vir Biotechnology
CureVac Initiates Rolling Submission with EMA for COVID-19 Vaccine
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, has initiated a rolling submission with the European Medicines Agency (EMA) for CVnCoV, the company’s mRNA-based COVID-19 vaccine candidate.
Over the course of the rolling submission process, the EMA will assess CVnCoV’s compliance with standards for efficacy, safety, and pharmaceutical quality on the basis of individually submitted data packages as a prerequisite for a formal market authorization application.
CVnCoV is being studied in Phase IIb/III clinical trials in Europe and Latin America in healthy adults at a dose of 12 µg.
News on COVID-19 testing
FDA Grants Emergency Use for Thermo Fisher’s COVID-19, Flu Test
The US Food and Drug Administration has granted emergency use authorization for Thermo Fisher Scientific’s Applied Biosystems TaqPath COVID-19 Flu A, Flu B Combo Kit, a PCR test for the detection and differentiation of RNA from the SARS-CoV2, the virus that causes COVID-19, and influenza A and influenza B viruses. The test is conducted using nasopharyngeal and nasal swabs. The kit includes Applied Biosystems’ Pathogen Interpretive Software to automatically convert genetic analysis data into a readable report.
Source: Thermo Fisher Scientific
BD Gets Emergency Use Authorization in US, EU for COVID/Flu Test
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Becton, Dickinson and Company (BD), a Franklin Lakes, New Jersey-based medical technology company, for its molecular diagnostic test for both SARS-CoV-2 and Influenza A/B. The test also received the CE marking, administrative marking that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.
The new EUA includes updated information in the test’s instructions for use that addresses variants of the SARS-COV-2, the virus that causes COVID-19, including variants from the UK and South Africa. This ability to detect these new variants also applies to the stand-alone SARS-CoV-2 test for the BD MAX System, a molecular diagnostic platform.
The BD SARS-CoV-2/Flu assay is run on the BD MAX System and distinguishes between SARS-CoV-2 and Influenza A+B, providing a positive or negative result for each virus using a single specimen.
The BD SARS-CoV-2/Flu for BD MAX System kits are available for order in the US and Europe.
Source: Becton, Dickinson and Company