Pharma COVID Roundup: News from GSK, Roche, Merck & Co., and WHO

The latest on manufacturing and potential treatments for COVID-19 with news from GSK, Roche, Merck & Co., Gilead, WHO, and Amarin.

GSK To Produce 1 Billion Doses of COVID-19 Vaccine Adjuvant
GlaxoSmithKline (GSK) has announced its intention to manufacture one billion doses of its pandemic vaccine adjuvant system in 2021 to support the development of multiple adjuvanted COVID-19 vaccine candidates.

GSK says it has prioritized its efforts toward making its pandemic adjuvant technology available to partners developing COVID-19 vaccine candidates that are suitable for use with an adjuvant. To date (as reported on May 28, 2020), the company has formed several collaborations, including with scientific partners in North America, Europe and China, to develop vaccines. Discussions with potential partners on further collaborations are ongoing.

The announcement of the enhanced manufacturing capacity follows completion of a review conducted across the company’s global supply network. GSK will manufacture and fill and finish adjuvant for use in COVID-19 vaccines at sites in the UK, US, Canada, and Europe.

GSK has started manufacture of the adjuvant at risk. The company is in discussions with governments and global institutions about funding for production and supply of the adjuvant. GSK says it does not expect to profit from sales of its portfolio of collaborations for COVID-19 vaccines made during this pandemic phase as profit generated will be invested in support of COVID-19-related research and long-term pandemic preparedness, either through GSK’s internal investments or with external partners.

Source: GlaxoSmithKline

Roche Starts Phase III Trial of Arthritis Drug Plus Remdesivir in COVID-19
Roche has initiated a global Phase III, randomized, double-blind, multicenter study to evaluate the safety and efficacy of the company’s Actemra/RoActemra (tocilizumab), a drug to treat certain forms of arthritis, with Gilead Sciences’ investigational antiviral drug candidate, remdesivir, in hospitalized patients with severe COVID-19 pneumonia.

The study, in which Roche and Gilead are collaborating, is expected to begin enrolling in June (June 2020) with a target of approximately 450 patients globally. Remdesivir was issued an emergency use authorization by the US Food and Drug Administration (FDA) for the treatment of hospitalized patients with severe COVID-19.

Roche also reports it is close to completing enrollment of a global randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the safety and efficacy of intravenous Actemra/RoActemra plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia. The first patient was randomized on April 3, 2020. In total, the company says approximately 450 patients will be enrolled in the study and that it expects to share data from the study this summer (summer 2020).

This study is conducted in collaboration with the FDA and the Biomedical Advanced Research and Development Authority, part of the US Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. In addition, Roche is also a participant in the Accelerated COVID-19 Therapeutic Interventions and Vaccines partnership, which is led by the National Institutes of Health (NIH) and the Foundation of the NIH.

Source: Roche

Merck & Co., Ridgeback Form Pact for COVID-19 Antiviral Candidate
Merck & Co. and Ridgeback Biotherapeutics, a Miami, Florida-based biopharmaceutical company focused on orphan and emerging infectious diseases, have entered into an agreement to develop EIDD-2801, an orally available antiviral candidate currently in early clinical development for the treatment of patients with COVID-19.

Under the agreement, Merck, through a subsidiary, will gain exclusive rights to develop and commercialize EIDD-2801 and related molecules. Ridgeback Biotherapeutics will receive an undisclosed upfront payment, specified milestones, and a share of the net proceeds of EIDD-2801 and related molecules, if approved. Merck will be responsible for clinical development, regulatory filings, and manufacturing. The transaction is subject to the expiration or earlier termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and other customary closing conditions.

Source: Merck & Co.

Gilead’s Remdesivir Granted Early Access for COVID-19 by UK
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s pharmaceutical regulatory authority, has issued a positive opinion for an early-access-to-medicines scheme (EAMS) for Gilead Sciences’ remdesivir, an investigational antiviral drug candidate for treating COVID-19, to provide the drug via the UK’s National Health Service (NHS) to hospitalized patients with severe cases of COVID-19.

EAMS was set up by the MHRA to give patients with life-threatening or seriously debilitating conditions access to medicines that are not yet licensed when there is a medical need. Following advice from the Commission on Human Medicines, an advisory committee of the MHRA, and the Expert Working Group on COVID-19, the MHRA has delivered this scientific opinion after an evaluation of the benefit/risk balance of remdesivir based on the data available.

Remdesivir’s current use in the UK will be for patients in cases of high unmet medical need determined by a physician through the EAMS, where it will be provided to the NHS free of charge by Gilead throughout the EAMS period. It will also continue to be used in clinical trials. Several clinical trials to evaluate remdesivir and its possible effects on patients with COVID-19 have already been approved by the MHRA and are ongoing in the UK.

Source: The Medicines and Healthcare products Regulatory Agency

WHO Halts Trials of Hydroxychloroquine for Treating COVID-19
The World Health Organization (WHO) announced this week (May 25, 2020) that it is temporarily halting its clinical trials that use hydroxychloroquine, a drug approved for treating malaria, lupus, and rheumatoid arthritis that is being evaluated to treat COVID-19, as a precaution over the risk/benefit profile of the drug.

The announcement follows the publication in The Lancet, a medical journal, findings that COVID-19 patients receiving hydroxychloroquine or chloroquine did not achieve better outcomes and had decreased in-hospital survival rates. The findings were based on a multinational registry analysis of the use of hydroxychloroquine or chloroquine with or without a macrolide antibiotic for the treatment of COVID-19. The authors of the study reported that they were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for COVID-19 and that each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19.

The WHO has 3,500 patients from 17 countries enrolled in a global clinical trial, the Solidarity Trial, in which one arm of the trial was evaluating hydroxychloroquine in patients in COVID-19 patients. The WHO’s Executive Group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity Trial while the data are reviewed by a Data Safety Monitoring Board.

In a related action, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), France’s pharmaceutical regulatory agency, reported this week (May 26, 2020) that it was suspending the inclusion of patients being treated with hydroxychloroquine to treat COVID-19, in clinical trials conducted in France.

Since the start of the COVID-19 epidemic, ANSM has authorized 16 clinical trials evaluating hydroxychloroquine. Patients being treated with hydroxychloroquine in these clinical trials may continue to do so until the end of the protocol.

ASNM said it was taking this action after pending new data on the use of hydroxychloroquine in patients with COVID-19. The agency said that only the results of randomized clinical trials on hydroxychloroquine, whether or not combined with azithromycin, a macrolide antibiotic, can provide evidence of its efficacy and safety.

Source: WHO and ASNM (in French)

Amarin Supports COVID-19 Investigational Trial for Cholesterol Drug
Amarin Corporation, a Dublin, Ireland-based biopharmaceutical company focused on cardiovascular disease, has announced support for a clinical trial to investigate the effects of  Amarin’s Vascepa (icosapent ethyl), a purified omega-3 fatty acid used as an anti-cholesterol and cardiovascular drug, on inflammatory biomarkers and other patient outcomes in individuals with COVID-19. The trial is sponsored by the Canadian Medical and Surgical Knowledge Translation Research Group, a Toronto, Ontario-based not-for-profit physician organization.

The trial’s primary endpoint is to evaluate the effect of Vascepa versus usual care on high-sensitivity C-reactive protein levels from baseline to 14 days in adults with a COVID-19-positive diagnosis. The clinical study design also includes other endpoints that assess rates and severity of COVID-19 infection in this high-risk group.

Amarin says multiple mechanisms of action associated with Vascepa from clinical and mechanistic studies support the rationale to study its effects in patients with COVID-19 infection. Additional postulated mechanisms that might play a role in the use of Vascepa in the patients infected with COVID-19 include: (1) potential antiviral/antimicrobial effects; (2) fibrosis and cardiac damage mitigation in animal models; and (3) anti-inflammatory effects (acute) in pulmonary/lung tissue.

Source: Amarin

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