As healthcare systems around the world continue to struggle with managing the rates of transmission and mortality in patients with COVID-19, an announcement made in late April by Dr. Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, gave hope to the public that an effective treatment for the disease may not be completely out of reach.
In his statement, Fauci referred to the results of a study where Gilead Sciences’ antiviral drug, remdesivir, was administered to 1,000 patients from several sites around the world. Fauci said that “the data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery.”
Despite the promising results, the effectiveness of remdesivir in blocking the replication of SARS-CoV-2 (the virus responsible for COVID-19) has received some skepticism. Remdesivir, which was originally developed to treat Ebola was administered in a controlled clinical trial in China where no drop in the viral load was observed. Therefore, the results of this study which was published in the Lancet imply that if remdesivir is effective in reducing the duration of illness, those positive effects are not due to its antiviral properties.
Gilead is also facing competition from other big players in the biotech industry. Regeneron has announced that they are ramping up clinical trials for their antibody cocktail and may be able to make it available to the public by the Fall. AbCellera and Lilly have also partnered to develop antibody therapeutics to treat and prevent COVID-19.
Despite the skepticism and competition that Gilead is facing for its antiviral drug, further clinical trials continue to be conducted and the California-based company is looking to expand the reach of its treatment.
Gilead Signs Licensing Deals with Firms in Developing Countries
Subsequent to Gilead receiving emergency use authorization for remdesivir from the FDA, the pharma company went on to sign licensing deals for the production of generic version of their antiviral drug with firms in more than 100 countries. Most of the deals were signed with developing countries that face major challenges in accessing affordable health care. These licences are going to stay royalty-free until a more effective treatment is developed or until the World Health Organization declares that COVID-19 is no longer a worldwide emergency.
This is not the first time that Gilead has made deals with generic drug companies for its patented pharmaceuticals. The company has previously worked with firms in lower-income countries to enable development and sales of cheaper alternatives to its HIV and hepatitis C treatments.
Access to healthcare has never been so important than in face of a rapidly-spreading infectious disease that has affected almost every part of the world. Existing provisions under the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) allow least-developed countries (LDCs) to forgo the consent of a patent holder to copy a patented drug for wide-spread use within the country. However, compulsory licencing of patented medications continues to be a controversial issue for pharmaceutical companies as well as middle-income and poor countries that are not covered by provisions that protect LDCs from intellectual property infringement lawsuits. In fact, a famous lawsuit that was brought in 2016 against the government of Colombia by Norvartis, the manufacturer of the cancer drug Gleevec, perfectly captures this ongoing battle between pharma companies and the governments of developing countries. The suit was brought after Health Minister Alejandro Gaviria unilaterally reduced the price of Gleevec following the issuing of ‘Declaration of Public Interest’ in order to make the leukemia medication more accessible for citizens of Colombia. Norvartis argued that Gaviria’s declaration was “issued improperly and creates an unwarranted and damaging precedent that could apply to any patent-covered innovations, not just pharmaceuticals.”
Gilead’s decision to avoid similar legal battles by signing voluntary licensing deals with generic companies and allowing lower-income countries to access cheaper versions of remdesivir has not diminished its potential to make huge profits from its antiviral drug. In fact, experts are now projecting that the sales of remdesivir could reach $7.7 billion USD in 2022.
Gilead’s Stock Market Performance- Gains and Losses
In response to the announcement made by Dr. Fauci regarding the positive effects of remdesivir on COVID-19 patients, Gilead’s shares increased by 5.5% in late April. Despite the initial hike in value, Gilead’s stocks took a hit after the results of Phase 3 of its clinical trials were published. Those results were not as impressive as investors had previously hoped, even though they revealed that patients who had received the antiviral drug in addition to standard of care did better than the control group in a five-day treatment course. Following this reporting, Gilead’s share value dropped from $78 to $73 USD in the span of two trading sessions. Although Gilead’s stocks recovered, some experts remain skeptical of the long-term demand for remdesivir.
The Bottom Line
The results of remdesivir clinical trials conducted to date on patients of COVID-19 show that the effects of the antiviral treatment are moderate and that Gilead’s drug is not a ‘silver bullet’ by any means. There is still little published about the long-term effects of the antiviral drug on patients of COVID-19. Experts are currently looking into multi-drug combination therapies in order to optimize the positive effects of the antiviral treatment. It is plausible that similar to the combination therapy that was developed for HIV infection, Gilead’s remdesivir would have to be administered alongside other antiviral agents in order to have significant impact on the virus. Of course, an effective vaccine for COVID-19 could completely change the game for Gilead and its competitors.
Written by Bonnie Hassanzadeh, IPilogue editor and Clinic Fellow at Osgoode Innovation Clinic.