Pharma COVID Roundup: News from Novavax, Moderna, Lilly, Regeneron
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The latest on COVID-19 vaccines/drugs and manufacturing from Novavax, Moderna, Lilly, Regeneron, CureVac, Glenmark, and the World Health Organization.

Manufacturing and supply of COVID-19 vaccines and drugs

EU To Purchase Up To 200 M Doses of Novavax’s COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has reached an agreement with the European Commission for the purchase of up to 200 million doses of its COVID-19 vaccine candidate, NVX-CoV2373.

The agreement covers the purchase of up to 100 million doses of the vaccine with the option for an additional 100 million doses through 2023. Novavax is working to complete its rolling submission for NVX-CoV2373 to the European Medicines Agency in the third quarter of 2021, with delivery of initial doses expected to begin following approval.

In a Phase III clinical trial in the US and Mexico, NVX-CoV2373 demonstrated 100% protection against moderate and severe disease and 90.4% overall efficacy. In a Phase III clinical trial conducted in the UK, NVX-CoV2373 showed an overall efficacy of 89.7%, and more than 96% efficacy against the original strain of the virus.

Novavax’s global supply chain spans more than 10 countries, including facilities across the European Union from which it plans to ultimately supply doses. In its second-quarter 2021 earnings results reported this month (August 5, 2021), the company reported that it is on track globally to achieve capacity of 100 million doses per month by the end of the third quarter of 2021 and 150 million doses per month by the end of the fourth quarter 2021.

Source: Novavax and the European Commission


WHO, Others Move Forward with South African mRNA Tech Transfer Hub
Several organizations, including the World Health Organization (WHO), have signed a letter of intent to establish the South African mRNA technology transfer hub. The signing of the letter of intent follows WHO’s announcement in June of the first COVID mRNA vaccine technology transfer hub in South Africa. The letter of intent sets out the terms of the collaboration and responsibilities between the participating organizations. In addition to WHO, these include: the Medicines Patent Pool, a United Nations-backed public health organization; Afrigen Biologics, a Cape Town, South Africa-based bio/pharmaceutical company; the Biologicals and Vaccines Institute of Southern Africa (Biovac), a Cape Town, South Africa-based bio/pharmaceutical company; the South African Medical Research Council, a medical research organization; and the Africa Centers for Disease Control and Prevention.

Source: World Health Organization


Glenmark Partners in Asia for Supply of Nasal COVID-19 Drug
Glenmark Pharmaceuticals, a Mumbai, India-headquartered pharmaceutical company, and SaNOtize Research and Development, a Vancouver, Canada-based biotech company, have entered into an exclusive long-term strategic partnership to manufacture, market and distribute SaNOtize’s nitric oxide nasal spray (NONS) as a COVID-19 treatment, in India and other Asian markets, including Singapore, Malaysia Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam.

NONS is designed to kill the virus in the upper airways and prevent it from incubating and spreading to the lungs.

Last month (July 2021), Glenmark presented a proposal to the Subject Expert Committee of India’s Central Drugs Standard Control Organization (CDSCO) for emergency approval for the import and marketing of the nasal spray. The committee recommended a Phase III clinical trial to be conducted in Indian patients in the weeks to follow (as reported on August 2, 2021). The companies expect a Phase III clinical trial for NONS to be completed by the fourth quarter of 2021.

Source: Glenmark Pharmaceuticals and SaNOtize Research and Development


Updates on COVID-19 treatments and vaccines

Novavax Provides Update for Regulatory Filings for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, reported in its second-quarter 2021 results on August 5, 2021 that the company expects to submit its COVID-19 vaccine for emergency use authorization to the US Food and Drug Administration in the fourth quarter of 2021.

Novavax’s COVID-19 vaccine, NVX-CoV2373, is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M adjuvant.

The company also expects to complete regulatory filing with the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the third quarter of 2021. The company expects to complete additional regulatory filings in other markets within weeks of the MHRA filing, including with the European Medicines Agency, the Australian Therapeutic Goods Administration, Health Canada, and New Zealand Medsafe.

In addition, Novavax, with its partner, the Serum Institute of India (SII), have filed regulatory submissions for emergency use authorization of Novavax’s COVID-19 vaccine to the Drugs Controller General of India (DCGI) and regulatory agencies in Indonesia and the Philippines.

SII and Novavax have now completed the submission of all modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls data. A GMP joint site inspection of SII was successfully completed by the DCGI in May 2021. SII is developing, manufacturing, and commercializing the vaccine in India.

A submission to the World Health Organization (WHO) for emergency use listing (EUL) based on the DCGI submission is expected to be filed in August (August 2021). The grant of EUL by the WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries. Novavax and SII have cumulative commitments to provide more than 1.1 billion doses to the COVAX Facility.

Source: Novavax (second quarter results) and Novavax (submission in India)


WHO Calls for Moratorium on COVID-19 Vaccines Boosters
In a press briefing this week (August 4, 2021), the World Health Organization‘s Director General, Dr Tedros Adhanom Ghebreyesus, called for a moratorium on boosters of COVID-19 vaccines until at least the end of September (September 2021) to increase vaccinations in low and low-middle countries to enable at least 10% of the population of every country to be vaccinated. WHO reported that 4 billion vaccine doses have been administered globally with more than 80% to high- and upper-middle income countries and is calling on G-20 countries to increase vaccine supply to lower-income countries.

Meanwhile, the Task Force on COVID-19 Vaccines, Therapeutics and Diagnostics for Developing Countries, established by the heads of the International Monetary Fund, World Bank Group, World Health Organization and the World Trade Organization to identify and resolve finance and trade impediments to vaccine, diagnostics, therapeutic production and deliveries, is calling on countries with advanced COVID-19 vaccination programs to release as much of their contracted COVID-19 vaccine doses as possible to low- and low-middle income countries. The task force said that vaccine delivery schedules to these countries are delayed or are too slow with less than 5% of vaccine doses that were pre-purchased by or for low-income countries delivered. The target is for at least 40% of people in low and low-middle income countries to be vaccinated by the end of 2021.

Source: World Health Organization (press briefing) and World Health Organization (task force)


Moderna on Six-Month Efficacy, Booster Results of COVID-19 Vaccine
In its second-quarter 2021 results, Moderna reported six-months durability data from a Phase III study that showed that its COVID-19 vaccine had 93% efficacy, with the efficacy remaining durable through six months after administration of a second dose.

Moderna also provided Phase II results of three mRNA vaccine booster candidates (mRNA-1273 [its currently authorized vaccine] and two investigational vaccines mRNA-1273.351 and mRNA-1273.211) against variants of concern. The company reported that these booster candidates induced antibody responses against the wildtype D614G COVID-19 strain and against important variants of concern, including Gamma (P.1); Beta (B.1.351); and Delta (B.1.617.2). Neutralizing antibody levels following the boost approached those observed after primary vaccination with two doses of 100 µg of mRNA-1273. These data have been submitted to a peer-reviewed journal for publication.

Source: Moderna


FDA Broadens Emergency Use Authorization for Lilly’s COVID-19 Drug
The US Food and Drug Administration (FDA) has broadened the emergency use authorization (EUA) for baricitinib, Lilly’s arthritis drug also authorized for treating COVID-19, to allow for treatment with or without remdesivir, Gilead Sciences’ antiviral COVID-19 drug.

Previously, the EUA was restricted to use only in combination with remdesivir. The EUA now provides for the use of baricitinib for treating COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

Baricitinib is an oral JAK inhibitor discovered by Incyte, a Wilmington, Delaware-based biopharmaceutical company, and licensed to Lilly.

Source: Eli Lilly and Company (EUA), Eli Lilly and Company (Phase III results), the US Food and Drug Administration, and Incyte


FDA Expands Authorization for Regeneron’s COVID-19 Antibody Cocktail
The US Food and Drug Administration (FDA) has revised the emergency use authorization for REGEN-COV (casirivimab and imdevimab), the antibody cocktail for treating COVID-19 from Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company.

The authorization now includes post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination and have been exposed to a SARS-CoV-2 infected individual, or who are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting. This new indication in people aged 12 and older is in addition to the previously granted authorization to treat non-hospitalized patients.

Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply of the antibody cocktail, with Roche primarily responsible for development and distribution outside the US.

Source: Regeneron and the US Food and Drug Administration


CureVac Reports Phase IIb/III Results of COVID-19 Vaccine
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, reported results from its Phase IIb/III study of its COVID-19 vaccine candidate, CVnCoV.

The company reported that in the context of 15 strains circulating within the study population at the time of final analysis, CVnCoV demonstrated an overall vaccine efficacy of 48% against COVID-19 of any severity, including single non-respiratory mild symptoms. Protection among participants aged 18 to 60 had efficacy of 53% against disease of any severity across all 15 identified strains. Protection against moderate-to-severe disease was 77%. In the same age group, CVnCoV provided 100% protection against hospitalization or death.

The study will continue to complete follow-up analyses for trial participants. Available data have been communicated to the European Medicines Agency.

CureVac is also developing COVID-19 vaccine candidates in partnership with GlaxoSmithKline (GSK). CureVac and GSK expect to progress a vaccine candidate into clinical testing in the third quarter of 2021, with the goal of introducing the vaccine in 2022, subject to regulatory approval.

Source: CureVac

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