Pharma COVID Roundup: News from J&J, Novavax, Roche, and Regeneron

The latest on manufacturing and potential treatments for COVID-19 with news from J&J, Novavax, Roche, Regeneron, BI, Dr. Reddy’s, CSL, and others.

J&J in Supply Pact with UK Gov’t for its COVID Vaccine Candidate
Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J), has agreed in principle to collaborate with the UK government on a global Phase III clinical trial to explore the two-dose regimen of its SARS-CoV-2 vaccine candidate, Ad26.COV2.S, as well as for supplying additional doses to the UK government.

The parties will negotiate a final advance purchase agreement in due course under which the UK government would initially purchase 30 million doses of Janssen’s Ad26.COV2.S vaccine candidate on a not-for-profit basis for emergency pandemic use. The agreement will also provide the option for an additional purchase by the UK government of up to a further 22 million vaccine doses.

J&J’s collaboration with the UK government is for its global Phase II clinical trial to explore the two-dose regimen of its SARS-CoV-2 vaccine candidate, Ad26.COV2.S. This global study will run in parallel to the Phase III trial investigating the single-dose regimen of Ad26.COV2.S.

The Phase I/IIa trial of the vaccine candidate, Ad26.COV2.S, is underway in healthy volunteers in the US and Belgium. J&J says planning is underway for a Phase III program trial, which is subject to interim data of the Phase I trials and approval of regulators.

Source: Johnson & Johnson

Novavax, Fujifilm in Mfg Pact with UK Gov’t for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has signed a heads of terms (term sheet) with the UK government for the purchase of 60 million doses of NVX-CoV2373, Novavax’s COVID-19 vaccine, and for a Phase III clinical trial to assess the efficacy of the vaccine in the UK population.

Novavax will also expand its collaboration with Fujifilm Diosynth Biotechnologies, a biologics CDMO, to manufacture the antigen component of NVX-CoV2373. Fujifilm Diosynth will manufacture from its sites in the UK (Billingham) and the US (North Carolina and Texas). Novavax will supply 60 million doses of NVX-CoV2373 to the UK beginning as early as the first quarter of 2021. Excess supply of antigen manufactured at Fujifilm Diosynth’s site in Billingham may be available for Novavax to sell to additional markets outside the UK. Fujifilm Diosynth’s UK site is expected to produce up to 180 million doses annually, which further boosts the global supply of NVX-CoV2373 for additional markets.

The Phase III clinical trial is expected to begin in the third quarter of this year (2020), with the UK government supporting and providing infrastructure to Novavax in the execution of the trial. The trial will assess the ability of NVX-CoV2373 to protect against symptomatic COVID-19 disease as well as evaluate antibody and T-cell responses.

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19. NVX-CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’s patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

Source: Novavax and Fujifilm Diosynth Biotechnologies

Novavax Initiates Phase IIb Trial of COVID Vaccine in South Africa
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has announced the beginning of a Phase IIb clinical trial in South Africa to evaluate the efficacy of NVX-CoV2373, the company’s COVID-19 vaccine candidate. The trial is supported in part by a $15-million grant from the Bill & Melinda Gates Foundation.

The Phase IIb clinical trial of NVX-CoV2373 will include two cohorts. One cohort will evaluate efficacy, safety and immunogenicity in approximately 2,665 healthy adults. The second cohort will evaluate safety and immunogenicity in approximately 240 medically stable, HIV-positive adults. Novavax says it expects that, if approved in South Africa, its COVID-19 vaccine would be supplied to South Africa through Novavax’s recently announced collaboration with the Serum Institute of India.

Novavax says it intends to initiate a Phase II portion of this trial in the US and Australia in the near future (as reported on August 17, 2020). This trial will include approximately 1,500 subjects and will include older adults.

The Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases, is funding the manufacturing of doses of NVX-CoV2373 for this Phase IIb clinical trial.

Source: Novavax

Roche, Regeneron in Supply Pact for COVID Antibody Drug Cocktail
Roche and Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, have entered into an agreement to develop, manufacture, and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination therapy for COVID-19.

This collaboration is expected to increase supply of REGN-COV2 to at least three and a half times of current capacity with the potential for even further expansion. Under the agreement, each company has committed to dedicate a certain amount of annual manufacturing capacity for REGN-COV2 and have already begun the technology-transfer process. Each company will also bear its own distribution expenses in their designated territories.

In addition, the companies will jointly fund and execute an ongoing Phase III prevention and a Phase I healthy volunteers safety studies as well as additional global studies to evaluate further REGN-COV2 in treating or preventing COVID-19. Roche will be primarily responsible for securing regulatory approvals outside the US, following initial approval from European Medicines Agency approval and for conducting any additional studies specifically required for approval by regulators outside the US.

REGN-COV2 is currently being studied in two Phase II/III clinical trials for the treatment of COVID-19 and in a Phase III trial for the prevention of COVID-19 in household contacts of infected individuals. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute REGN-COV2 in the US, and Roche will be responsible for distribution outside the US.

Source: Roche and Regeneron Pharmaceuticals

J&J Leading CARE Project in Europe for COVID-19
Johnson & Johnson (J&J) has founded and is co-leading the new CARE (Corona Accelerated R&D in Europe) consortium, a multi-partner scientific research initiative in Europe, to accelerate the discovery and development of medicines to treat SARS-CoV-2, the virus that causes COVID-19. Boehringer Ingelheim (BI) has signed on as a member of the consortium.

CARE is supported by the Innovative Medicines Initiative (IMI), a public-private partnership in the life sciences, which is funded by the European Union and the private sector. With a grant totaling EUR 77.7 million ($92 million), CARE is funded by cash contributions from the European Union (EU) and cash and in-kind contributions from 11 companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA), the pharmaceutical trade association representing innovator, research-based companies in Europe, and three IMI-associated partners.

CARE is a five-year project bringing together 37 partners from Belgium, China, Denmark, France, Germany, the Netherlands, Poland, Spain, Switzerland, the UK and the US. It is led by VRI-Inserm (the French National Institute of Health and Medical Research) (Paris), Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Beerse, Belgium), and Takeda Pharmaceuticals International AG, (Zurich, Switzerland). It has been integrating partners’ COVID-19 projects since February 2020.

As a member of the CARE consortium, BI will be leading the work stream of the consortium focusing on the development of virus neutralizing antibodies. The company will provide antiviral molecules from its HIV and hepatitis C virus portfolio and small-molecule candidates from a screen of its molecule library.

The consortium builds on three pillars: (1) drug repositioning, by screening and profiling compound libraries contributed by partners with the aim of rapidly progressing molecules to advanced stages of clinical testing; (2) small-molecule drug discovery based on in silico screening and profiling of candidate compounds directed against SARS-CoV-2 and future coronavirus targets; and (3) virus neutralizing antibody discovery using fully human phage and yeast display, immunization of humanized animal models, patient B cells, and in silico design.

Source: Johnson & Johnson and Boehringer Ingelheim

Dr. Reddy’s Launches Favipiravir for COVID-19 in India
Dr. Reddy’s Laboratories, a Hyderabad, India-based pharmaceutical company, has launched In India Avigan (favipiravir), an antiviral drug of Fujifilm Toyama Chemical for treating COVID-19.

The launch is part of the global licensing agreement with Fujifilm Toyama Chemical that grants Dr. Reddy’s the exclusive rights to manufacture, sell, and distribute Avigan 200-mg tablets in India.

Avigan has been approved by the Drugs Controller General of India for the treatment of patients with mild-to-moderate COVID-19 disease.

Source: Dr. Reddy’s Laboratories

CSL in Talks with AstraZeneca to Manufacture COVID Vaccine
CSL, a Melbourne, Australia-based pharmaceutical company, says it is currently in discussions with AstraZeneca and the Australian government to assess whether it is possible for it to provide local manufacturing support for Oxford University’s/AstraZeneca’s COVID-19 vaccine candidate.

CSL says it is assessing the viability of options ranging from the fill–finish of bulk product imported to Australia through to manufacture of the vaccine candidate under license. CSL saysthere are a number of technical issues to work through and discussions are ongoing, in a statement issued on August 18, 2020.

The company said that its development of a COVID-19 vaccine with the University of Queensland (UQ) in Australia remains a priority. In February (February 2020), CSL partnered with UQ to provide technical expertise as well as a donation of its proprietary adjuvant technology to support UQ’s preclinical development program of a COVID vaccine. In June (June 2020), UQ, CSL and the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private partnership focused on vaccine development against emerging infectious diseases, formed a partnership in which CEPI and CSL will fund clinical development and industrial-scale manufacturing of the vaccine of potentially millions of doses  per year, should the vaccine be approved, with CSL as the manufacturer.

Source: CSL

FDA OKs Emergency Use for Yale’s Saliva-Based COVID Test
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to the Yale School of Public Health at Yale University for the university’s SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection.

The SalivaDirect test does not require any special type of swab or collection device; a saliva sample can be collected in any sterile container and does not require a separate nucleic acid extraction step. The SalivaDirect methodology has been validated and authorized for use with different combinations of commonly used reagents and instruments, thereby allowing the test to be used broadly in most high-complexity labs, according to the FDA.

Yale says it intends to provide the SalivaDirect protocol to interested laboratories as an “open source” protocol, meaning that designated laboratories could follow the protocol to obtain the required components and perform the test in their lab according to Yale’s instructions for use. Because this test does not rely on any proprietary equipment from Yale and can use a variety of commercially available testing components, it can be assembled and used in high-complexity labs throughout the country, provided they comply with the conditions of authorization in the EUA.

This is the fifth test that the FDA has authorized that uses saliva as a sample for testing. Testing saliva eliminates the need for nasopharyngeal swabs, which have also been prone to shortages, and alleviates the patient discomfort associated with these swabs, says the FDA. Since the saliva sample is self-collected under the observation of a healthcare professional, the FDA says it could also potentially lower the risk posed to healthcare workers responsible for sample collection. While the FDA has seen variable performance in tests using saliva, the Yale School of Public Health submitted data with its EUA request from which the FDA determined that Yale’s test meets the criteria for emergency authorization when used to test saliva samples for SARS-CoV-2, the virus that causes COVID-19.

Source: US Food and Drug Administration

McKesson in US Gov’t Pact to Distribute COVID-19 Vaccines
McKesson Corporation, a wholesale distributor of pharmaceuticals and medical products, will expand its existing partnership with the Centers for Disease Control (CDC) as a centralized distributor of future COVID-19 vaccines and ancillary supplies needed to administer vaccinations.

The expanded partnership will support the US government’s Operation Warp Speed, a US government initiative to accelerate the development of vaccines and treatments against COVID-19. Vaccines and related supplies will be delivered to point-of-care sites across the country at the US government’s direction.

McKesson has other partnerships with the US goverment. The CDC is executing an existing contract option with McKesson to support vaccine distribution as part of the CDC’s Vaccines for Children Program. CDC and McKesson collaborated similarly in response to the H1N1 pandemic in 2009-2010. The current contract with McKesson, awarded as part of a competitive bidding process in 2016, includes an option for the distribution of vaccines in the event of a pandemic.

The US Department of Defense says detailed planning is underway to ensure rapid distribution as soon as the US Food and Drug Administration authorizes one or more vaccines. Once these decisions are made, McKesson will work under CDC’s guidance to ship COVID-19 vaccines to administration sites.

Source: McKesson Corporation and the US Department of Defense

TFF Pharmaceuticals, Union Therapeutics in Pact for COVID Drugs
TFF Pharmaceuticals, an Austin, Texas-based clinical-stage biopharmaceutical company, has entered into a worldwide exclusive licensing agreement with Union Therapeutics, a Hellerup, Denmark-based clinical-stage pharmaceutical company, for its thin-film freezing (TFF) technology in combination with niclosamide to treat COVID-19.

Niclosamide was recently identified by the Institut Pasteur Korea as an inhibitor of SARS-CoV-2, the virus causing COVID-19. Union Therapeutics is currently conducting a Phase I clinical trial of an optimized salt form of niclosamide as a potential inhalation treatment of COVID-19 and a Phase IIb study of niclosamide in atopic dermatitis patients.

Under the agreement, Union Therapeutics will acquire an option to obtain a worldwide exclusive license for TFF Pharmaceuticals’ TFF technology to be used with niclosamide, including oral and inhalation versions of niclosamide, potentially for treating COVID-19, as well as other niclosamide-based therapies. Subject to Union Therapeutics’ exercise of its option, Union has agreed to pay TFF Pharmaceuticals potential development, regulatory, and sales-related milestone payments of up to $210 million. Union Therapeutics will also pay TFF tiered single-digit royalties on product sales. TFF Pharmaceuticals and Union Therapeutics have agreed to collaborate on securing government support (contracts, grants, etc.) with the aim of funding the development of niclosamide-based products for the treatment of COVID-19.

Source: TFF Pharmaceuticals and Union Therapeutics

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