Pharma COVID Roundup: News from AstraZeneca, Merck & Co., GileadBy
The latest on COVID-19 vaccines/drugs and manufacturing from AstraZeneca, Merck & Co., Gilead Sciences, Dr. Reddy’s, Valneva, Inovio, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
AstraZeneca Responds to EU’s Legal Action on Supply of COVID-19 Vaccine
AstraZeneca has issued a statement on the legal action the European Commission is taking against the company regarding the supply of the company’s COVID-19 vaccine to the European Union.
“AstraZeneca regrets the European Commission’s decision to take legal action over the supply of COVID-19 vaccines,” said the company in an April 26, 2021 statement. “Following an unprecedented year of scientific discovery, very complex negotiations, and manufacturing challenges, our company is about to deliver almost 50 million doses to European countries by the end of April [April 2021], in line with our forecast. AstraZeneca has fully complied with the Advance Purchase Agreement with the European Commission and will strongly defend itself in court. We believe any litigation is without merit, and we welcome this opportunity to resolve this dispute as soon as possible.”
The company also reported it is the leading supplier to more than 100 countries through the COVAX Facility, a global initiative for equitable access to COVID-19 vaccines, providing 97% of its supply to date (as reported on April 26, 2021).
Merck & Co., Generics Companies in Pact for COVID-19 Drug in India
Merck & Co. has entered into non-exclusive voluntary licensing agreements with five Indian generics manufacturers for molnupiravir, an oral antiviral agent for treating mild-to-moderate COVID-19.
Merck has entered into these agreements to accelerate availability of molnupiravir in India and in other low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.
The agreements have been signed with Cipla, Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Hetero Labs, and Sun Pharmaceutical Industries. These five generics manufacturers have World Health Organization pre-qualified manufacturing facilities and experience as major suppliers to global and key LMIC procurers. Under the agreements, Merck will provide licenses to these manufacturers to supply molnupiravir to India and more than 100 LMICs. Merck is also in discussions with the Medicines Patent Pool, a United Nations-backed public health organization working to increase access to and facilitate the development of medicines to LMICS, to explore the potential for additional licenses.
Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics, a Miami, Florida-based biopharmaceutical company. Molnupiravir is currently being studied in a Phase III trial for treating non-hospitalized patients with confirmed COVID-19.
Separately, Merck will also donate more than $5 million worth of oxygen-production equipment, masks, hand sanitizers, and financial aid to support relief efforts in India.
Source: Merck & Co. and Hetero Labs
Gilead To Expand Availability of Remdesivir in India
Gilead Sciences has announced steps to expand availability and scale up production of remdesivir, its antiviral drug for treating COVID-19, in India. It plans include providing its voluntary licensing partners with technical assistance, support for the addition of new local manufacturing facilities, and the donation of the active pharmaceutical ingredient (API). Gilead will also donate at least 450,000 vials of Veklury (remdesivir).
All seven of Gilead’s licensees based in India have accelerated production of remdesivir by scaling up their batch sizes, adding new manufacturing facilities, and/or onboarding local contract manufacturers across the country. While these efforts are expected to increase availability of remdesivir in the coming weeks (as reported on April 26, 2021), Gilead will donate at least 450,000 vials of Veklury to the Indian government to help ease the immediate need for treatment.
To safeguard against disruption of generic remdesivir supply to other low- and middle-income countries included as part of the voluntary licenses, Gilead says it is also committed to providing support to voluntary licensees based outside of India to increase their production capacity. Gilead’s planned support will include the donation of API to licensees with a view to accelerate production.
Gilead’s voluntary licensing program for remdesivir, established in May 2020, has enabled access to the drug for more than 2.3 million people in more than 60 low- and middle-income countries. The program, which builds on Gilead’s voluntary licensing model for its HIV and viral hepatitis medicines, provides long-term licenses to nine manufacturers, seven of which are based in India, to enable access to remdesivir in 127 countries, most of which are low- and middle-income countries, including India.
Valneva in Discussions To Supply COVID-19 Vaccine
Valneva, a Saint-Herblain, France-headquartered vaccine company, has announced it is focusing on bilateral discussions, on a country-by-country basis, to supply its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001, and is consequently deprioritizing the ongoing centralized discussions with the European Commission (EC).
Valneva had previously announced the advanced stage of its discussions, which started in the third quarter of 2020 with the EC. In September 2020, Valneva announced a collaboration with the UK government to provide up to 190 million doses of VLA2001 through 2025, of which 100 million doses have already been ordered.
Additionally, Valneva has initiated a Phase III trial to compare VLA2001 against AstraZeneca’s conditionally approved COVID-19 vaccine, Vaxzevria, in a comparative immunogenicity trial. The trial will be conducted in the UK and is supported by the National Institute for Health Research.
Source: Valneva (supply) and Valneva (Phase III trial)
Minapharm To Produce Russia’s COVID-19 Vaccine
Minapharm, a Cairo, Egypt-based pharmaceutical company that focuses on recombinant DNA technology, and its Berlin-based subsidiary, ProBioGen, have entered into an agreement with Russian Direct Investment Fund (RDIF), a sovereign wealth fund in Russia, to produce over 40 million doses per year of Sputnik V, a COVID-19 vaccine developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology.V.
RDIF and Minapharm will initially supply over 40 million doses per year. Production will take place in Minapharm’s facility in Cairo for global distribution. ProBioGen AG aims to undertake efforts for process optimization to further increase production.
The parties intend to commence technology transfer immediately (as reported on April 22, 2021). The rollout of the vaccine is expected in the third quarter of 2021.
Updates on COVID-19 treatments and vaccines
EU Agencies Start Initiative for Monitoring COVID-19 Vaccines
The European Medicines Agency (EMA) and the European Center for Disease Prevention and Control (ECDC) have started a new initiative for post-marketing monitoring of COVID-19 vaccines in the European Union (EU) and the European Economic Area (EEA).
These studies will be used to provide continuous assessment of the benefits and risks of the vaccines and inform decision-making on their use in national or regional vaccination strategies for different populations.
The EMA and ECDC will jointly coordinate and oversee a number of observational studies, which will be funded from the EU budget and conducted in several European countries. In line with their respective mandates and in collaboration with EU/EEA countries, the EMA leads on monitoring the safety, and ECDC the effectiveness, of these vaccines. This work will be supported by a joint advisory board to the two agencies.
Source: European Medicines Agency and the European Centre for Disease Prevention and Control
WHO Committee Updates Guidance for AstraZeneca’s COVID-19 Vaccine
The World Health Organization’s (WHO) Strategic Advisory Group of Experts on Immunization has updated its interim guidance on the use of AstraZeneca’s COVID-19 vaccine, including new data related for further clarification of precautions and types of risk (i.e., thrombosis with thrombocytopenia syndrome).
WHO continues to support the conclusion that the benefits of AstraZeneca’s COVID-19 vaccine outweigh the risks.
More data have been obtained on the effectiveness of the vaccines in different population groups, such as older adults. Additionally, clarifications and specifications have been added as to the vaccination of specific population groups, such as pregnant and lactating women, person with previous SARS-CoV2 infection, and others.
Source: World Health Organization
US Gov’t Stops Funding for Phase III Trial of Inovio’s COVID-19 Vaccine
The Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) has notified Inovio, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, that it will discontinue funding for the Phase III trial evaluating Inovio’s COVID-19 vaccine candidate, INO-4800.
The DoD JPEO-CBRND, in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency, will discontinue funding for the Phase III segment of the trial while continuing to fund the completion of the ongoing Phase II segment.
With existing global collaborators such as inovio’s China partner, Advaccine, a Suzhou, China-based biopharmaceutical company, and the International Vaccine Institute, a nonprofit international vaccines organization, Inovio is planning for a predominantly ex-US global Phase III trial based on upcoming evaluation of Phase II safety and immunogenicity data.
Inovio also continues to evaluate its pan-COVID variant vaccine, INO-4802, to protect against current and future variants of concern, as well as assessing boosting capabilities for INO-4800.
Dr. Reddy’s Gets OK for Russia’s COVID-19 Vaccine in India
Dr. Reddy’s Laboratories has received approval from the Drug Controller General of India (DCGI) to import Sputnik V, a COVID-19 vaccine developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology.V, into India for emergency use.
In September 2020, Dr. Reddy’s partnered with the Russian Direct Investment Fund (RDIF), a sovereign wealth fund in Russia, to conduct clinical trials of Sputnik V and distribute the vaccine in India. In addition to the trials conducted in Russia by RDIF. Phase II/III clinical trials of the vaccine were carried out by Dr. Reddy’s in India.
Source: Dr. Reddy’s Laboratories
Health Canada Initiates Review of Medicago’s COVID-19 Vaccine
Health Canada, the pharmaceutical regulatory body of Canada, has initiated a rolling review of a plant-derived adjuvanted COVID-19 vaccine candidate from Medicago, a Quebec-based biopharmaceutical company.
In parallel with the review of the rolling submission, Medicago is conducting a Phase III trial. The last portion of the interim order rolling submission will be filed after the COVID-19 vaccine efficacy and safety endpoint of the Phase III trial is reached.