Gilead building ‘a geographically diverse consortium’ to address remdesivir supplies

Gilead Sciences’ investigational drug remdesivir for Covid-19 finds itself in the eye of a storm involving access, even as a set of preliminary trial results are expected in May.

Questions are rife on how United States-based Gilead proposes to make the antiviral drug accessible to patients across the world, if indeed remdesivir is found effective in tackling the novel coronavirus.

“We are in active discussions with multiple US and global agencies, and are also consulting bioethicists and other advisors, to help determine how best to meet the public health needs of this outbreak with our available product supply,” a Gilead Sciences spokesperson said, responding to queries from BusinessLine .

Efforts are on to balance two needs, the spokesperson said, “first, to try to help individuals in urgent need, by offering remdesivir under the expanded access programs, and second, to support clinical trials that can provide a clearer understanding of the product’s safety and efficacy and potentially enable the treatment of many more people in need.”

Giving an insight into the road ahead on remdesivir, Gilead said, “We are building a geographically diverse consortium of pharmaceutical and chemical manufacturing companies to work together in a coordinated fashion to help us meet and exceed our production goals by expanding capacity for raw materials and production beyond what any company could do individually. We would hope that before any country issues a compulsory license (CL) that they first speak to us about how they can be a part of a coordinated supply solution.”

A CL allows a third party to make an innovative drug on payment of royalty to the original company.

Recently, patient and health advocacy groups have urged Governments to take such steps and override Gilead’s patents on remdesivir, so other companies would be able to make it at lower prices.

Gilead has been in a similar situation with its breakthrough Hepatitis C drug Sofosbuvir, whose high price was a bone of contention. The biopharmaceutical company then inked voluntary licensing deals with Indian generic drugmakers like Cipla, Cadila Healthcare, Strides and others, allowing them to make less expensive versions of the same drug, while limiting its sale to certain countries. The move was criticised by some health advocacy groups. And now the concern is that Gilead would do the same with remdesivir, as well.

Gilead said it had in two months increased the available supply of the drug using its inventory of Active Pharmaceutical Ingredients (API). “Our existing supply, including finished product ready for distribution as well as investigational medicine in the final stages of production, amounts to 1.5 million individual doses,” it said. The entire existing supply was being given “at no cost” to treat patients with the most severe symptoms of COVID-19, the company said.

CLs and production concern

On countries exercising the CL option, Gilead said it was concerned “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.”

Remdesivir production involves “a long linear chemical synthesis process that must be completed sequentially and includes several specialized chemistry steps and novel substances with limited global availably. The process is both resource- and time-intensive, with some individual manufacturing steps taking weeks to complete,”the company said.

And because Remdesivir is administered intravenously, production also requires sterile drug product manufacturing capabilities, which limits the number of organizations capable of manufacturing the medicine, it added. “This complex process impacts the ability to rapidly produce large quantities of drug supply in an emergency situation like the COVID-19 pandemic. Disruptions in the supply chain would negatively impact the delivery of remdesivir to patients, should it be found to be safe and effective,” it said.

Override patents

Leena Menghaney, South Asia head with Medecins Sans Frontieres’ Access Campaign, said that peopleacross the globe were anxiously waiting for outcomes of clinical trials, including that of remdesvir.

“Control over supply and price of this drug currently lie solely in Gilead’s hands, even though the research and development of remdesivir is the result of a massive collective effort, involving many actors and multiple public resources.”

Gilead Sciences has patents on the drug in many countries and that may block generic versions from entering the market until 2031, she said. And that would mean, “the drug would not be accessible to millions of people across the globe who may need it to stay alive in this pandemic,”she added.

Pointing out that Gilead was possibly pursuing bilateral voluntary licenses with generic companies including Indian manufacturers as it had done with HIV and HCV medicines, she said, the model was not acceptable in a global health emergency.

“We are urgently asking governments to take immediate steps to override Gilead’s patents and not grant Gilead any other exclusivities, so that generic manufacturers around the world can produce more of this drug at affordable prices. Gilead should make all necessary technical know-how publicly available so that multiple manufacturers can produce remdesivir in order to meet global demand,” she said.

Drugmakers in China and a Taiwanese research institute have said they have the capacity to produce remdesivir. Indian generic companies too were working on developing remdesivir, she pointed out.

If the drug is effective, a network of manufacturers in different countries, including low- and middle-income countries, must be established for a rapid scale-up of supply, she said, under the watch of United Nations’ agencies to safeguard supplies to countries with weaker health systems and insufficient manufacturing capacity.

Without directly addressing calls to revoke patents made by organisations like the Cancer Patients Aid Association, Gilead said “We are 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.”