Pharma COVID Roundup: News from Lilly, AstraZeneca, GSK, Pfizer, Roche
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The latest on manufacturing, potential treatments, and testing for COVID-19 with news from Lilly, AstraZeneca, GSK, Pfizer, Roche, Merck & Co., Thermo Fisher, and others.

Manufacturing and supply of COVID-19 vaccines and drugs

Pfizer/BioNTech, EU in Pact for 4 M More COVID-19 Vaccine Doses
The European Commission (EC) has reached an agreement with Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, for the supply of four million more doses of their COVID-19 vaccine for European member states in the next two weeks (as reported on March 10, 2021) in order to address COVID-19 hotspots and the spread of COVID-19 variants.

The EC says it is concerned by the development of a series of COVID-19 hotspots across the EU due to the spread of new variants. The Pfizer/BioNTech COVID-19 vaccine has proven effective against all currently known variants, according to information from the EC. Regions, such as Tyrol in Austria, Nice and Moselle in France, Bolzano in Italy, and some parts of Bavaria and Saxony in Germany and other regions in other member states have seen the number of infections and hospitalizations rise over the past weeks (as reported on March 10, 2021), leading member states to adopt new measures and in certain cases to impose new border controls.

In order to support member states in their efforts to respond to these developments, the EC has negotiated with Pfizer/BioNTech the possibility for member states to order supplementary COVID-19 vaccines doses. The increase of dose deliveries in March (March 2021) is a result of the successful expansion of manufacturing capacities in Europe, which was completed by mid-February (February 2021).

Four million doses in total will be made available for purchase to EU member states, pro-rata to their population. All of these doses will be delivered before the end of March (March 2021), according to the EC. These doses come on top of the schedule of deliveries currently agreed between EU member states and Pfizer/BioNTech.

Source: European Commission


Jubilant, Lilly in Mfg Pact for COVID-19 Drug; EU Begins Rolling Review
Jubilant HollisterStier, a CDMO of sterile manufacturing, has signed a contract manufacturing agreement with Eli Lilly and Company for bamlanivimab, Lilly’s neutralizing antibody against COVID-19. The drug will be manufactured at Jubilant HollisterStier’s facility in Spokane, Washington.

Bamlanivimab alone is authorized under special/emergency pathways, in the context of the pandemic, in numerous countries, including the US, Canada, the Czech Republic, Germany, Israel, Italy, Hungary, Sweden, Rwanda, Morocco, and the United Arab Emirates. A combination therapy of bamlanivimab and etesevimab is authorized for emergency use in the US and Italy.

In the European Union, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has started rolling reviews of bamlanivimab bamlanivimab administered together with etesevimab.

EMA will evaluate all data on these medicines, including evidence from clinical trials as they become available. The rolling review will continue until enough evidence is available to support formal marketing authorization applications. Last week (March 5, 2021), the EMA’s CHMP issued a positive opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab.

Additionally, Lilly reported positive results from a Phase III study demonstrating bamlanivimab (700 mg) and etesevimab (1,400 mg) together reduced risk of hospitalizations and death by 87%. These results provide additional efficacy and safety data that support the use of the dose recently granted authorization by the FDA and the positive scientific opinion by the EMA’s CHMP.

Source: Jubilant HollisterStier, Eli Lilly and Company (EMA), Eli Lilly and Company (Phase III results), and the European Medicines Agency


Updates on COVID-19 treatments and vaccines

Denmark, Norway, Austria Suspend AstraZenca’s COVID-19 Vaccine
The Danish Health Authority, the Norwegian Institute of Public Health, and the Austrian National Competent Authority have decided to stop vaccinations with AstraZeneca’s COVID-19 vaccine for the next 14 days (as reported on March 11, 2021) due to reports of cases of blood clots in people who were vaccinated.

Due to the reports, the European Medicines Agency (EMA) and other drug regulatory authorities in Europe have launched an investigation into the vaccine.

The EMA says there is currently no indication that vaccination has caused these conditions, which are not listed as side effects with the vaccine. The position of EMA’s safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), is that the vaccine’s benefits continue to outweigh its risks and that the vaccine can continue to be administered while investigation of cases of thromboembolic (blood clot) events is ongoing. PRAC is already reviewing all cases of thromboembolic events, and other conditions related to blood clots, reported post-vaccination with AstraZeneca’s COVID-19 vaccine.

As of March 10, 2021, the EMA reports that 30 cases of thromboembolic events were reported among close to 5 million people vaccinated with AstraZeneca’s vaccine in the European Economic Area. The EMA says it will further communicate as the assessment progresses.

The EMA says that a given batch (Batch ABV5300) used in vaccinations in Austria was delivered to 17 EU countries and comprises 1 million doses of the vaccine. Some EU countries also subsequently suspended this batch as a precautionary measure while a full investigation is ongoing. The EMA says that although a quality defect is considered unlikely at this stage, the batch quality is being investigated.

In Denmark, all booked appointments and invitations to vaccination with the vaccine from AstraZeneca are cancelled for the time being. The Norwegian Institute of Public Health says that appointments arranged for vaccination with the AstraZeneca’s COVID-19 vaccine will now be cancelled or replaced with offers of mRNA vaccines from Pfizer/BioNTech and Moderna.

Source: Danish Health Authority, Norwegian Institute of Public Health, the European Medicines Agency (investigation), and the European Medicines Agency (Austria)


GSK, Vir Plan To File for Authorization for COVID-19 Drug in the US
GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based clinical-stage biopharmaceutical company, plan to file for emergency use authorization (EUA) with the US Food and Drug Administration for VIR-7831, a drug for treating COVID-19. In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19.

The decision to file for an EUA followed positive Phase III results and a recommendation by an independent data monitoring committee (IDMC) to stop the Phase III trial due to positive results.

The Phase III results showed the drug as a monotherapy used in the early treatment of COVID-19 resulted in an 85% reduction in hospitalization or death. Based on these results, Vir and GSK plan to submit an EUA to the FDA and for authorizations in other countries. Data from this registrational trial will also form the basis for a biologics license application submission to the FDA.

The companies also announced today the results of a new study submitted and pending online publication in bioRxiv, demonstrating that VIR-7831 maintains activity against current circulating variants of concern, including the UK, South African, and Brazilian variants, based on in vitro data from pseudotyped virus assays.

VIR-7831 is also being evaluated in the outpatient setting in a Phase II trial designed 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 another monoclonal antibody, VIR-7832, will be evaluated in a 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.

Source: GlaxoSmithKline and Vir Biotechnology


Pfizer/BioNTech COVID-19 Vaccine 97% Effective in Israeli Population
The Israel Ministry of Health (MoH), Pfizer, and BioNTech, a Mainz, Germany-based immunotherapy company, have reported real-world evidence demonstrating Pfizer’s/BioNTech’s COVID-19 vaccine is 97% effective in fully vaccinated individuals in Israel.

The latest analysis from the MoH shows that two weeks after the second vaccine dose, vaccine effectiveness was at least 97% in preventing symptomatic disease, severe/critical disease, and death, and 94% against asymptomatic SARS-CoV-2 infections.

Findings from the analysis were derived from de-identified aggregate Israel MoH surveillance data collected between January 17, 2021 and March 6, 2021, when the Pfizer’s/BioNTech’s COVID-19 vaccine was the only vaccine available in the country and when the more transmissible B.1.1.7 variant of SARS-CoV-2 (formerly referred to as the UK variant) was the dominant strain.

In January (January 2021), Pfizer and Israel’s MoH entered into a collaboration agreement to monitor the real-world impact of the Pfizer’s/BioNTech’s COVID-19 vaccine.

Source: Pfizer and BioNTech


EMA Begins Rolling Review of Russia’s COVID-19 Vaccine
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology.

Sputnik V is made up of two different viruses belonging to the adenovirus family, Ad26 and Ad5. These adenoviruses have been modified to contain the gene for making the SARS-CoV-2 spike protein. The two adenoviruses are given separately. Ad26 is used in the first dose, and Ad5 is used in the second to boost the vaccine’s effect.

The CHMP’s decision to start the rolling review is based on results from laboratory studies and clinical studies in adults. These studies indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2, the virus that causes COVID-19, and may help protect against COVID-19.

The EMA will assess Sputnik V’s compliance with the usual European Union (EU) standards for effectiveness, safety and quality. The EMA says while it cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review. The agency will communicate further when the marketing authorization application for the vaccine has been submitted. The EU applicant for this medicine is R-Pharm Germany, an Illertissen, Bayern, Germany-based pharmaceutical company.

Source: European Medicines Agency


Roche Reports Results of Its Arthritis Drug and Gilead’s Remdesivir for COVID-19
Roche reports that a Phase III study evaluating Roche’s arthritis drug, Actemra/RoActemra (tocilizumab), with Gilead Sciences’ antiviral COVID-19 drug, Veklury (remdesivir) versus placebo plus Veklury did not meet its primary endpoint.

This was measured by improved time to hospital discharge up to Day 28 in patients with severe COVID-19 pneumonia receiving standard of care. No new safety signals were identified in the trial.

The Phase III study also did not meet key secondary endpoints, which included likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status. The full results of the trial will be submitted for publication in a peer-reviewed journal later this year (2021).

Roche says it will continue to evaluate data from the studies as well as other studies of Actemra/RoActemra in COVID-19 pneumonia.

Source: Roche


Merck & Co., Ridgeback Report Positive Results for COVID-19 Therapy
Merck & Co. and Ridgeback Biotherapeutics, a Miami, Florida-based biopharmaceutical company, have reported positive preliminary results from Ridgeback’s Phase IIa trial evaluating molnupiravir, an investigational oral antiviral therapeutic agent for COVID-19. The companies formed a licensing pact and collaboration to develop the drug last July (July 2021).

The Phase IIa study enrolled 202 non-hospitalized adults who had signs or symptoms of COVID-19 within seven days and confirmed active SARS-CoV-2 infection. The interim results showed a reduction in time to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2, the virus that causes COVID-19.

The full study results remain blinded and will be shared at a later date as they become available. Other Phase II and Phase II/III studies are underway (as reported on March 6, 2021).

Source: Merck & Co.


CPI Gets $7 M from UK Gov’t To Develop COVID-19 Vaccines Library
The Center for Process Innovation (CPI), an independent technology innovation center and a founding member of the UK government’s High Value Manufacturing Catapult, has been awarded an £5 million ($7 million) from the UK government to Gabaliya support the development of an mRNA vaccine library as part of the UK government’s vaccine support package against new variants of COVID-19.

The vaccine library will form the basis of a rapid response facility, which will enable mRNA vaccines to be developed to help protect against new variants of COVID-19, as and when they emerge. When new variants of COVID-19 are identified, their DNA can be used to develop mRNA vaccines. The vaccines will be banked in a “vaccine library,” ready for future manufacture and scale-up when needed, with the potential to deliver up to one million doses in a week for use in clinical trials.

CPI, part of the High Value Manufacturing Catapult, has been working with the UK Vaccine Taskforce since March 2020 in the development of mRNA vaccines to address COVID-19.

Source: Center for Process Innovation


News on COVID-19 testing

Thermo Fisher Launches PCR Assays for COVID-19 Variants
Thermo Fisher Scientific has launched its Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel, a customizable menu of 22 verified real-time PCR assays for identification of mutations of SARS-CoV-2, the virus that causes COVID-19.

These assays enable surveillance of variants that are causing COVID-19 infections in specific regions globally and allow laboratories to choose which mutations to track. The TaqMan SARS-CoV-2 Mutation Panel is designed to run a few or hundreds of samples to identify one or many mutations. The mutation panel provides results in about an hour and is based on the TaqMan SNP genotyping assay technology to help detect and distinguish mutations.

Source: Thermo Fisher Scientific


FDA Authorizes Adaptive Biotechnologies’ COVID-19 Test
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the COVID-19 detection test developed by Adaptive Biotechnologies, a Seattle, Washington-based biopharmaceutical company.

The T-Detect COVID Test is a sequencing-based test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, the virus that causes COVID-19, indicating recent or prior infection with SARS-CoV-2.

Source: US Food and Drug Administration and Adaptive Biotechnologies


FDA Authorizes Cue Health’s OTC, At-Home COVID-19 Test
The US Food and Drug Administration (FDA) has issued an emergency use authorization to Cue Health, a San Diego, California-based health technology company, for its over-the-counter, at-home diagnostic test for COVID-19.

The COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular test that can be used at home without a prescription by people with or without COVID-19 symptoms. It requires the use of a compatible smartphone and a downloadable app. The app provides testing instructions and works with the Cue Cartridge Reader and the Cue testing cartridge to perform the test. Results are available in about 20 minutes.

Source: US Food and Drug Administration

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