Pharma COVID Roundup: News from Lilly, Novartis, AstraZeneca, GSK
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The latest on manufacturing, potential treatments, and testing for COVID-19 with news from Lilly, AstraZeneca, GSK, Novartis, Roche, Pfizer, CureVac, Novavax, and Moderna.

Manufacturing and supply of COVID-19 vaccines and drugs

US Gov’t Purchases More Doses of Lilly’s COVID-19 Antibody Cocktail
The US government has agreed to purchase a minimum of 100,000 doses of Eli Lilly and Company’s COVID-19 combination therapy (bamlanivimab, 700 mg, and etesevimab ,1,400 mg).

The purchase agreement is for $210 million, and doses will be delivered through March 31, 2021. The US government will have the option to purchase up to an additional 1.1 million doses through November 25, 2021, under the same terms as the base agreement and subject to agreement from Lilly, product availability, and the medical need in the US.

The US government already committed to purchase a total of 1.45 million doses of bamlanivimab alone, which includes more than 1 million doses that have been delivered and an agreement to deliver 450,000 additional doses by March 31, 2021.

Lilly will begin shipping these additional doses immediately (as reported on February 26, 2021). The federal government directs the distribution of bamlanivimab alone and bamlanivimab and etesevimab together.

Last month (February 2021), the antibody cocktail of bamlanivimab and etesevimab received emergency use authorization from the US Food and Drug Administration for treating mild-to-moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization. Additionally, the National Institutes of Health (NIH) recently updated COVID-19 Treatment Guidelines to recommend the use of bamlanivimab plus etesevimab for treating outpatients with mild-to-moderate COVID-19 who are at high risk of clinical progression. Bamlanivimab alone is authorized for emergency use by the FDA for treating mild-to-moderate COVID-19 in high-risk patients.

Source: Eli Lilly and Company


Novartis To Manufacture CureVac’s COVID-19 Vaccine
Novartis has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate, CVnCoV, from CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines.

Following final agreement, Novartis plans to start production in the second quarter of 2021. Novartis plans to produce up to 50 million doses of the mRNA and bulk drug product for CureVac’s vaccine in 2021 and up to a further 200 million doses in 2022. First deliveries of the bulk drug product to CureVac are expected in the summer 2021. The bulk drug product will then be delivered to CureVac for further processing and filling.

Production will take place in a new production facility that was already under construction at Novartis’ Kundl, Austria site and which will be adapted for messenger RNA vaccine production for CureVac’s vaccine. Delivery from Novartis’ manufacturing site in Kundl, Austria is expected to start in the summer of 2021. Preparations for the start of production, technology transfer, and test runs are underway (as reported on March 4, 2021).

Novartis recently announced an initial agreement with BioNTech to provide manufacturing capacity for Pfizer’s/BioNTech’s COVID-19 vaccine at Novartis’ site in Stein, Switzerland.

Source: Novartis and CureVac


Mabion To Produce Antigen for Novavax’s COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, and Mabion, a Konstantynów Łódzki, Poland-based biopharmaceutical company, have entered into a framework agreement for the production of technical batches of antigen for Novavax’s COVID-19 vaccine candidate, NVXCoV2373, as an initial step toward a potential manufacturing contract.

Upon Mabion’s successful production of the technical batches, the companies may enter into a broader contract for the production of antigen for NVX-CoV2373 for commercial use, should it be approved by regulatory agencies.

Under the agreement, Mabion and Novavax will work to transfer technology for the production of a technical batch of NVX-CoV2373 to allow for the assessment of manufacturing feasibility at a commercial scale. These initial steps for demonstration of feasibility will be conducted over the course of the first half of 2021. Upon successful completion, Mabion’s manufacturing facility could become a part of the supply chain for commercial production of Novavax’s adjuvanted protein-based vaccine.

The full-scale technical batch, as well as other elements stipulated in the first stage of the contract, will be funded by non-refundable remuneration from Novavax. The agreement specifies the details of the first work order while the scope of further potential orders will be covered in potential subsequent contracts.

Source: Mabion


AstraZeneca Advances Rollout of COVID-19 Vaccine via COVAX
AstraZeneca has initiated the rollout of its COVID-19 vaccine to low-and middle-income countries globally through the multilateral COVAX facility, a global initiative for equitable access to COVID-19 vaccines.

COVAX is a global mechanism co-founded by Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases, and Gavi, a global public health partnership working with World Health Organization, UNICEF, civil society organizations, and industry groups to accelerate the development, production, and equitable access to new COVID-19 treatments and vaccines globally.

As of March 2, 2021, the first COVAX shipments were dispatched to Ghana and Cote D’Ivoire, and more are due to begin arriving this week (week of March 1, 2021) in countries, including the Philippines, Indonesia, Fiji, Mongolia, and Moldova. This supply represents the first COVID-19 vaccine for many of these countries.

Further shipments will arrive in the coming weeks (as reported on March 2, 2021) with the aim of supplying a total of 142 countries with hundreds of millions of doses of the vaccine in the coming months. The majority of these doses, manufactured by AstraZeneca and its license partner, the Serum Institute of India, a vaccine manufacturer, will go to low-and middle-income countries.

Vaccine shipments have been allocated according to the COVAX Allocation Framework, which determines volume per participating country based on a number of factors, including country readiness, national regulatory authorizations, and national vaccination plans in place. The supply through COVAX follows the recent emergency use listing of the AstraZeneca vaccine by the World Health Organization (WHO) for active immunization in individuals 18 years of age and older.

The AstraZeneca vaccine as co-invented by the University of Oxford and its spin-out company, Vaccitech. In addition to a program led by Oxford University, AstraZeneca is conducting a large trial in the US and globally. In total, Oxford University and AstraZeneca expect to enroll up to 60,000 participants globally.

The vaccine has been granted a conditional marketing authorization or emergency use in more than 50 countries as well as the recent Emergency Use Listing granted by WHO.

Source: AstraZeneca and Gavi


Pfizer’s, BioNTech’s COVID-19 Vaccine Arrives in Rwanda
The first doses of the COVID-19 vaccine from Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, has arrived in Rwanda through the COVAX Facility, a global initiative for equitable access to COVID-19 vaccines.

The companies report that this is their first delivery to a COVAX advanced market commitment country of their mRNA vaccine. The almost 103,000 doses will be used to vaccinate at-risk, front-line healthcare workers across the country.

Pfizer and BioNTech have already supplied doses through COVAX to South Korea and Colombia and say they will continue supplying doses to a number of diverse economies in all global regions, including a number of low-and lower-middle income countries, as part of the up to 40 million doses the companies have committed to the COVAX facility through 2021.

Source: BioNTech


Updates on COVID-19 treatments and vaccines

GSK, Vir Biotechnology Halt Trial Enrollment of COVID-19 Therapy
GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based clinical-stage biopharmaceutical company, have stopped enrollment of a Phase III study of VIR-7831, a drug being evaluated to treat hospitalized adults with COVID-19, over potential efficacy issues.

The companies were informed by the US National Institutes of Health (NIH) which is conducting an arm of the study, that while VIR-7831 met initial pre-specified criteria to continue to the next phase of the trial and there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of potential benefit.

An independent data and safety monitoring board (DSMB) has recommended that the VIR-7831 arm of the trial be closed to enrollment while the data mature. The companies will continue discussions with the NIH about appropriate ways to further assess VIR-7831 in hospitalized COVID-19 patients as all parties further evaluate the data.

VIR-7831 is also being evaluated in the outpatient settings: (1) a Phase III trial for the early treatment of COVID-19 in adults at high risk of hospitalization or death; and (2) a Phase II trial sponsored by Eli Lilly and Company to assess the safety and efficacy of Lilly’s bamlanivimab alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild-to-moderate COVID-19.

Additionally, VIR-7831, along with VIR-7832, will be evaluated in the Phase Ib/IIa trial, supported by the UK National Health Service, in adults with mild-to-moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir–GSK collaboration to be investigated as a potential COVID-19 treatment. The companies formed a collaboration to develop treatments for COVID-19 last April (April 2020).

Source: GlaxoSmithKline and Vir Biotechnology


EMA Advisory Committee Issues Positive Opinion on Regeneron’s COVID-19 Antibody Cocktail
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Regeneron’s investigational COVID-19 antibody cocktail (consisting of casirivimab and imdevimab), REGEN-COV.

The advisory committee’s recommendations can now be used to support national advice on the possible use of the treatment before a marketing authorization is issued. In parallel, a rolling review is ongoing. Once finalized, it will be the basis for an EU marketing authorization for this combination.

In November 2020, the US Food and Drug Administration authorized the antibody cocktail for emergency use for treating mild-to-moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

Roche and Regeneron are collaborating to develop, manufacture and distribute the antibody cocktail of casirivimab and imdevimab, with the aim of having more than two million doses available in 2021. Regeneron is responsible for development and distribution in the US, and Roche is primarily responsible for development and distribution outside the US, with the first Roche-manufactured doses already being distributed.

The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority, part of the US Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response.

Source: Regeneron, Roche, and the European Medicines Agency


EMA Advisory Committee Evaluates Cellitron’s COVID-19 Treatment
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is evaluating regdanvimab, from Celltrion, an Incheon, South Korea-based biopharmaceutical company, to support national authorities that may decide on the use of this medicine for COVID-19 prior to authorization.

The evaluation is in addition to an ongoing rolling review of regdanvimab for treating COVID-19 patients who do not require supplemental oxygen therapy and are at high risk for progressing to severe COVID-19 and/or hospitalization.

While the more comprehensive rolling review is ongoing ahead of a possible application for a marketing authorization, the evaluation procedure of the CHMP will provide a shared EU expert opinion to national authorities that may take evidence-based decisions on early use of the medicine, e.g. in compassionate use programs. The EMA says it will communicate on the outcome of this review once it concludes.

Source: European Medicines Agency


EMA, Health Canada Publish Data on Moderna’s COVID-19 Vaccine
The European Medicines Agency (EMA) and Health Canada, the pharmaceutical regulatory body of Canada, have collaboratively published the full clinical data reviewed as part of their have collaboratively published the full clinical data reviewed as part of their authorizations of Moderna’s COVID-19 vaccine. The clinical data package is available on EMA’s clinical data website and Health Canada’s Public Release of Clinical Information portal.

EMA and Health Canada are working together with manufacturers to expedite the publication of clinical information underpinning their authorizations for medicines and vaccines for COVID-19. The clinical data for the Pfizer-BioNTech’s COVID-19 vaccine is expected to be published shortly (as reported on March 2, 2021).

Source: European Medicines Agency and Health Canada


News on COVID-19 testing

Roche SARS-CoV-2 Rapid Antigen Test OK’d in Germany
Roche has been granted special approval by the German Federal Institute for Drugs and Medical Devices to enable home use of its SARS-CoV-2 Rapid Antigen Test using a simple nasal swab for self-testing.

The test is a rapid test for the qualitative detection of a specific SARS-CoV-2 antigen in nasal swab samples. This test collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and more comfortable sampling procedure. Patients can perform the test at home with results ready after only 15 minutes. The test will be made available in pharmacies and requires no prescription.

This test is part of a partnership with SD Biosensor, a global bio-diagnostic company, with whom Roche also launched a SARS-CoV-2 Rapid Antibody Test in July 2020 and two SARS-CoV-2 Rapid Antigen Tests for professional use in September 2020 and February 2021.

Source: Roche


FDA Authorizes Quidel’s At-Home COVID-19 Test
The US Food and Drug Administration issued an emergency use authorization (EUA) for an at-home COVID-19 Test from Quidel, a San Diego-based provider of diagnostics testing services and assays.

The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.

In addition to this new prescription home test, Quidel also was issued an EUA in December 2020 for its QuickVue SARS Antigen Test, which is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high, moderate or waived complexity tests, as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.

Source: US Food and Drug Administration and Quidel

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