Gilead Sciences, the US-drug maker said it is open to collaborate with governments, pharmaceutical companies, including from India, and is even considering proposals of patent-pooling to expand capacity and provide access to its antiviral drug Remesdesivir for COVID-19 patients across the world.
"On the supply side, we are working to build a global consortium of pharmaceutical and chemical manufacturers to expand global capacity and production and have pledged to donate all our existing supply for patients in need," Gilead spokesperson told Moneycontrol in an email interview.
"It will be essential for countries to work together to create enough supply for people all over the world and we look forward to these collaborative efforts. In the event of regulatory action, we are in discussions with various groups about how we might bring remdesivir to the developing world," Gilead said.
The company didn't specify if there are any Indian generic drug companies in the consortium. However, there is a possibility of Indian companies becoming part of the consortium, in the past Gilead used voluntary licenses to rope in Indian companies to manufacture and launch HIV and hepatitis-C medications in low-middle-income countries (LMICs).
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Remdesivir has shown positive results in two clinical trials, one conducted by the company and another by US government in treating patients with severe COVID-19 disease. The results were announced on April 29. The drug maker said the latest data allows a shorter treatment time which allows more patients to get access to the potential treatment. Remdesivir is yet to be approved by USFDA. But the regulatory agency is reviewing clinical trial data and is expected to issue an emergency use authorisation anytime soon.
Globally there are about 3.24 million confirmed cases of COVID-19, around 230,615 people have died due to pandemic, according to Johns Hopkins Coronavirus Resource Center. India reported about 34,780 cases and 1151 deaths so far.
Exploring potential new formulations & combinations
Gilead said the newly released trial results will open up many opportunities to explore the utility and potential of remdesivir.
"Our teams will look at ways to potentially bring the treatment to a broader patient population by investigating other formulations and means of delivery. We will also engage with partners to explore how remdesivir might work with other therapies," the company said.
Gilead said it is aware of proposals for manufacturers to license their intellectual property under various pooled arrangements.
"We will carefully consider whether these proposals would benefit the amount of supply or the speed at which it is made available once we understand the details of such proposals," the company said.
A patent pooling allows for voluntary licenses on medicines patents that enable generic competition and facilitate the development of new formulations. Gilead in the past used patent pool to provide access to its life saving patented anti-HIV and hepatitis-C medicines to patients living in low-and-middle-income countries at affordable prices.
Gilead expressed concern over compulsory licensing, and said it is open to have dialogue with countries.
"Compulsory licensing is a concern – not because of intellectual property rights but because there is a real risk that it could create chaos in the supply chain for scarce raw materials and other manufacturing inputs that could reduce the amount of remdesivir that could be produced and increase the time it takes to do so," Gilead said.
"We would hope that before any country issues a compulsory license that they first speak to us about how they can be a part of a coordinated supply solution," the company added.
Gilead said Remdesivir is a result of a decade of research.
The company has patented the drug in US, China and other parts of the world. Gilead filed additional patent applications for remdesivir for its uses against coronavirus globally, including China, in 2016. The patent application for the uses against coronavirus is still pending in China.
Gilead said India is not on the Compassionate Use program for Remdesivir.
A compassionate use is the use of a new, unapproved drug to treat a seriously ill patient when no other treatments are available. Currently Gilead is providing the drug on compassionate use and expanded access criteria in US and certain other countries.
The company said for patients in India, they have enroll in the Solidarity trial of WHO."India is part of the large global study designed by the WHO - the Solidarity trial. This trial is the best way for patients to access remdesivir, enabling access to remdesivir and collecting data to inform the use of this investigational compound and support potential regulatory approvals that can enable broader use of remdesivir," the company said.