Pharma COVID Roundup: News from Pfizer, Gilead, AstraZeneca, Takeda
The latest on manufacturing and potential treatments for COVID-19 with news from Pfizer, Gilead Sciences, AstraZeneca, Takeda, Novavax, Daiichi Sankyo, and others.
Pfizer in Pact to Manufacture Gilead’s Remdesivir for COVID-19
Pfizer has entered into a multi-year agreement with Gilead Sciences to manufacture and supply Gilead’s remdesivir, an investigational drug for treating COVID-19, as one of multiple external manufacturing organizations supporting efforts to scale up supply of the drug.
Under the agreement, Pfizer will provide contract manufacturing services at Pfizer’s McPherson, Kansas facility to manufacture and supply remdesivir for Gilead.
Earlier this year (2020), the US Food and Drug Administration (FDA) approved emergency use authorization for remdesivir for treating COVID-19. Last week, Gilead filed the final part of a rolling new drug application with the FDA for marketing approval of remdesivir for treating COVID-19 (see story below).
Gilead Submits NDA for Remdesivir as COVID-19 Treatment
Gilead Sciences has submitted a new drug application (NDA) to the US Food and Drug Administration for Veklury (remdesivir), an investigational antiviral for the treatment of COVID-19.
Veklury is currently available in the US under an emergency use authorization for the treatment of hospitalized patients with severe COVID-19. The filing is the final tier of a rolling NDA submission that was initiated on April 8, 2020.
The filing is supported by data from two randomized, open-label, multi-center Phase III clinical studies of Veklury conducted by Gilead and a Phase III randomized, placebo-controlled study of Veklury conducted by the National Institute of Allergy and Infectious Diseases. These studies demonstrated that treatment with Veklury led to faster time to recovery compared with placebo and that a five-day or 10-day treatment duration led to similar clinical improvement, according to information from the company. Across studies, Veklury was generally well-tolerated in both the five-day and 10-day treatment groups, with no new safety signals identified, according to the company.
Veklury has been approved by multiple regulatory authorities globally, including in the European Union and Japan.
Source: Gilead Sciences
Zydus Cadila Launches its Remdesivir COVID-19 Treatment in India
Zydus Cadila, an Ahmedabad, India-based pharmaceutical company, has launched remdesivir, an investigational antiviral drug from Gilead Sciences for treating COVID-19, under the brand name Remdac in India.
Priced at Rs. 2800 ($37) for a 100-mg lyophilized injection, the drug will be made available across India through the company’s distribution chain to government and private hospitals treating COVID patients.
Earlier this year (June 2020), Zydus entered into a non-exclusive agreement with Gilead to manufacture and sell remdesivir, which has been issued an emergency use authorization by the US Food and Drug Administration (FDA), for treating severe symptoms of COVID 19. The active pharmaceutical ingredient (API) for the drug has been developed and manufactured at the company’s API manufacturing facilities in Gujarat, India.
Zydus also outlined its other projects for COVID-19. It is ramping up production, as needed, of hydroxychloroquine, a drug approved for treating malaria, lupus, and rheumatoid arthritis, and dexamethasone, a steroid, which are separately being evaluated to treat COVID-19. The company is also conducting clinical trials of pegylated interferon alpha IIb and desidustat, an investigational drug for treating anemia in chronic kidney disease, for the treatment and management of COVID 19. Also, the company’s plasmid DNA vaccine candidate, ZyCov-D, is now in Phase II of adaptive Phase I&II clinical trials.
Source: Zydus Cadila
Argentina, Mexico in Supply Pacts for AstraZeneca’s COVID-19 Vaccine
The governments of Argentina and Mexico have formed an agreement with AstraZeneca to allow for the production and distribution throughout Latin America of AstraZeneca’s COVID-19 vaccine candidate.
In a series of tweets posted on August 12, 2020, Argentine President Alberto Fernandez said that the agreement provides for the the transfer of technology for the initial production of between 150 million and 250 million doses to ensure the vaccine is available in the first half of 2021, if the results of the Phase III studies are positive and the vaccine is approved.
In a press conference on August 12, 2020 with Mexican President Andrés Manuel López and Sylvia Lorena Varela Ramón, President and General Director of AstraZeneca Mexico, Varela said AstraZeneca plans to initially produce 150 million doses, and with support of these governments, production could eventually increase to 400 million doses.
Takeda, Novavax in Pact for Novavax’s COVID-19 Vaccine in Japan
Takeda and Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, have entered into a partnership for the development, manufacturing and commercialization of NVX‑CoV2373, Novavax’s COVID‑19 vaccine candidate, in Japan.
NVX‑CoV2373 is a prefusion protein made using Novavax’s recombinant protein nanoparticle technology and includes Novavax’s proprietary saponin-based adjuvant, Matrix‑M. Under the agreement, Takeda will receive funding from the government of Japan via Japan’s Ministry of Health, Labor and Welfare (MHLW) to support the technology transfer, establishment of infrastructure, and scale-up of manufacturing. Takeda says it anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year.
Novavax will license and transfer manufacturing technologies to enable Takeda to manufacture the vaccine antigen and will supply the Matrix-M adjuvant to Takeda. Takeda will be responsible for regulatory submission to the MHLW and will produce and distribute NVX CoV2373 in Japan.
Novavax will be entitled to receive payments based on the achievement of certain development and commercial milestones, as well as a portion of proceeds from the vaccine.
Novavax, Serum Institute of India in Pact for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has formed a license agreement with Serum Institute of India (SII), a Pune, Maharashtra, India-based vaccine manufacturer, for the development and commercialization of NVX‑CoV2373, Novavax’s COVID‑19 vaccine candidate, in low- and middle-income countries (LMIC) and India.
This agreement excludes major upper-middle and high-income countries, for which Novavax continues to retain rights. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’s recombinant protein nanoparticle technology and includes Novavax’s proprietary saponin-based adjuvant, Matrix‑M.
For LMICs and India, Novavax and SII are partnering on clinical development, co-formulation, filling and finishing and commercialization of NVX-CoV2373. SII will be responsible for regulatory submissions and marketing authorizations. Novavax will provide to SII both vaccine antigen and its Matrix‑M adjuvant, and Novavax and SII are in discussions to have SII manufacture the vaccine antigen in India. Novavax and SII will split the revenue from the sale of product, net of agreed costs.
This agreement further boosts the gl bal supply of the NVX-CoV2373 vaccine and builds on Novavax’s collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private coalition focused on vaccine development against emerging infectious diseases. Through that partnership with CEPI, Novavax has committed to develop and manufacture significant amounts of NVX-CoV2373, if proved safe and effective.
Last week (August 7, 2020), SII entered into a partnership with Gavi, a global public health partnership, and the Bill & Melinda Gates Foundation to accelerate the manufacture and delivery of up to 100 million doses of COVID-19 vaccines for LMICs. The funding will support at-risk manufacturing by SII for candidate vaccines from AstraZeneca and Novavax, which will be available for procurement if they are successful in attaining full licensure and prequalification from the World Health Organization. This provides upfront capital to SII to help increase manufacturing capacity so that once a vaccine(s) gains regulatory approval and WHO prequalification, doses can be produced at scale for distribution to India and LMIC as part of the COVID-19 Vaccine Global Access (COVAX) Facility, a mechanism established by Gavi for a globally fair allocation framework, as early as the first half of 2021.
SII has set a ceiling price for vaccine(s) of $3 per dose. The arrangement also provides an option to secure additional doses if the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, a global collaboration of governments, scientists, businesses, civil society, and philanthropists and global health organizations, including the WHO, CEPI and the Bill & Melinda Gates Foundation, involved in diagnostics, vaccines, and treatments for COVID-19, sees a need for it.
Novavax, SK bioscience in Pact for Novavax’s COVID-19 Vaccine Candidate
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, and SK bioscience, a Pangyo, Gyeonggi, South Korea-headquartered biopharmaceutical company that specializes in vaccines and a subsidiary of SK Chemical, have announced a development and supply agreement for the antigen component of NVX-CoV2373, Novavax’s COVID-19 vaccine candidate, for supply to global markets including the COVID-19 Vaccine Global Access (COVAX) Facility.
In addition, the companies have signed a letter of intent with the Republic of Korea’s Ministry of Health and Welfare to work toward broad and equitable access to NVX-CoV2373 for the global market as well as to make the vaccine available in South Korea.
Under the terms of the agreement, SK bioscience will manufacture the vaccine antigen component for use in the final drug product globally during the pandemic period. SK bioscience, using its cell culture and recombinant protein capability, will initiate the production of the NVX-CoV2373 antigen at its vaccine facility in Andong L-house, South Korea beginning in August 2020.
This contract development and manufacturing organization agreement uses the capacity reservation agreement between SK bioscience and the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private coalition that seeks to derail epidemics by speeding up the development of vaccines. Novavax’s NVX-CoV2373 will be manufactured using a part of the reserved capacity at SK Bioscience’s “L-House” facility.
This agreement further boosts the potential global supply of the NVX-CoV2373 vaccine and is an important component of Novavax’s collaboration with CEPI. Through that partnership with CEPI, Novavax has committed to develop and manufacture significant amounts of NVX-CoV2373, including vaccine derived from antigen coming from SK bioscience, if proved safe and effective, to be procured and distributed by the COVAX Facility through a globally fair allocation framework.
NVX-CoV2373 was developed using Novavax’s recombinant nanoparticle technology to generate a stable, prefusion antigen derived from the coronavirus spike (S) protein. It contains Novavax’s saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Phase I data from the company’s Phase I/II randomized, observer-blinded, placebo-controlled trial shows that NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.
Daiichi Selected as Provider for Japanese Gov’ts COVID-19 Vaccine Project
Daiichi Sankyo has been selected by Japan’s Ministry of Health, Labour and Welfare of Japan to be a provider for the Japanese government’s “Emergent Initiative to Build Production Capacity for COVID-19 Vaccines (First Round)” for the company’s COVID-19 vaccine candidate.
The vaccine candidate, DS-5670, is a mRNA vaccine for COVID-19 using nucleic-acid delivery technology discovered by Daiichi Sankyo and which is slated to enter clinical studies around March 2021.
Under the agreement, Daiichi Sankyo will develop a supply system for DS-5670 at the plant of its subsidiary company, Daiichi Sankyo Biotech Co., located in Kitamoto, Saitama, Japan, and aims to build a platform for production technology in Japan that can respond not only to COVID-19 but also for future emerging and re-emerging infectious disease vaccines.
The Emergent Initiative to Build Production Capacity for COVID-19 Vaccines project aims to swiftly develop a large-scale production system for biologics, including vaccines, in order to ensure that the vaccines necessary for the prevention of the spread and severity of unexpected epidemics, including COVID-19, are produced and that supply is secured for the Japanese people.
Source: Daiichi Sankyo
Cipla Receives Approval to Launch Favipiravir for COVID-19 in India
Cipla, a Mumbai, India-based pharmaceutical company, has been granted regulatory approval by the Drug Controller General of India to launch in India favipiravir, a generic form of Fujifilm Toyama Chemical’s Avigan, an antiviral drug being evaluated to treat COVID-19, under Cipla’s brand name Ciplenza.
The accelerated approval for manufacturing and marketing of the drug is aimed at meeting medical need for COVID-19 treatment options in the country through restricted emergency use.
Cipla will commercially launch Ciplenza in the first week of August (August 2020) priced at Rs 68 ($1) per tablet. To ensure fair and equitable distribution of the drug, supplies will be undertaken predominantly through hospital channels and via open channels, prioritized for regions with high COVID-19 cases.
The drug was jointly developed by Cipla and CSIR-Indian Institute of Chemical Technology (IICT) in Hyderabad, Telangana, India. As part of this partnership, CSIR-IICT developed a synthetic process for favipiravir. The entire process and active pharmaceutical ingredient of the drug has been transferred to Cipla to manufacture and market the drug at scale.
SAB Biotherapeutics Awarded $35.6 M by US Gov’t for COVID Antibody Program
SAB Biotherapeutics, a Sioux Falls, South Dakota-based clinical-stage biopharmaceutical company, has been awarded an additional $35.6 million by the US government to expand the scope for therapeutic drug candidate, SAB-185, for COVID-19.
In sum, SAB has announced three awards from the US government now totaling $72 million for SAB-185 for development and for scaling capacity and capabilities for current and future product development from discovery through licensure.
In a separate development, on August 11, 2020, SAB announced the first patients in its Phase I study evaluating the safety of SAB-185 for treating COVID-19 have been dosed. The drug is being evaluated to potentially treat ill patients and provide protective antibodies tto protect high-risk populations against COVID-19. The Phase I study is for healthy volunteers to evaluate safety. Direct support for a Phase I and Phase Ib clinical evaluation of SAB-185 is provided by the DoD’s JPEO-CBRND on behalf of the OASD (HA) and DHA.
Arcturus Therapeutics Initiates Dosing of mRNA COVID-19 Vaccine Candidate
Arcturus Therapeutics, a clinical-stage messenger RNA (mRNA) medicines and vaccines company, has dosed all subjects in the first cohort in a Phase I/II clinical study of ARCT-021, the company’s investigational vaccine for COVID-19.
The ARCT-021 Phase I/II study includes two parts. In Phase I, escalating doses will be administered as a single injection to younger adults aged 21 to 55 years old. Based upon the safety, immunogenicity and T-cell response data from this group, dose regimens will be selected for further evaluation in Phase II, which includes cohorts in younger adults and older adults aged 56 to 80 years old.
Source: Arcturus Therapeutics
Biological E, Baylor College of Medicine in Pact to Develop COVID-19 Vaccine
The Baylor College of Medicine in Houston, Texas and Biological E. (BE), a Hyderabad, India-based pharmaceutical company, have entered into a licensing agreement for the development of a COVID-19 vaccine.
BE has licensed the recombinant protein COVID-19 vaccine candidate developed at Baylor. The company engaged in license negotiations with the BCM Ventures team, part of Baylor College of Medicine, after initial discussions on Baylor’s technology and how it could possibly inform a vaccine to address the current global pandemic. The company will use its past experience for the further development and commercialization of the vaccine candidate, which currently is produced using a yeast-based expression technology.
The current focus is on transfer of the technology for BE to initiate scale-up of the manufacturing process and undertake further development of the vaccine candidate.