Gilead has entered into a series of licensing agreements that give five generic drug manufacturers the rights and information needed to make the company’s COVID-19 drug, remdesivir.The agreements permit Mylan, Cipla, Hetero Labs, Jubilant Life Sciences and Ferozsons Laboratories to distribute the drug to 127 countries, most of which are classified as low- and lower-middle income. Gilead said the licensees will set their own prices for the generic remdesivir they produce, and won’t have to pay royalty fees until either the World Health Organization declares an end to the COVID-19 health crisis, or until a vaccine or drug other than remdesivir is approved to treat the disease.Gilead was met with pushback from at least two advocacy groups, including Public Citizen, which pointed out that about half the world’s population lives outside the countries included in the licensing agreements. Investors also reacted negatively, sending the California-based biotech’s stock down 3.5% by market’s open Wednesday.
Gilead executives have maintained that they don’t view remdesivir as a commercial opportunity. While that may be true, Gilead would likely receive substantial backlash if it set a high, profit-generating price tag on one of the few drugs to show some effectiveness at treating COVID-19, the disease caused by the novel coronavirus.
As of May 13, the virus had infected nearly 4.3 million people and killed close to 300,000 worldwide, according to a database maintained by Johns Hopkins University. With few treatment options beyond supportive care, demand for drugs like remdesivir is exceptionally high.
Gilead has said it will donate at no charge its current supply of 1.5 million remdesivir doses, which is enough to treat about 140,000 to 280,000 people depending on dose.
At the same time, the company is working to increase its manufacturing capacity, with an aim of producing another one million treatment courses by the end of the year. Gilead said it’s also been able to cut the time it takes to make remdesivir in half, though turnaround is still about six months because of the sequential steps needed for the chemical production process.
Now, the company is transferring manufacturing know-how to five generics makers, all of which have operations in either India or Pakistan. Gilead said the new deals, known formally as voluntary licensing agreements, will allow Mylan, Cipla and the rest to scale up production more quickly.
In a statement, Mylan said it is confident that it can develop an equivalent version of remdesivir, and that — pending reviews from regulatory agencies and the WHO — it will be able to provide the drug “in the coming months.”
Gilead has entered into similar voluntary licensing agreements before for its hepatitis C and HIV drugs. Though the company argues that these deals help ensure access to its medicines, patient and consumer groups have criticized their scope since they don’t include many countries.
In the case of remdesivir, Public Citizen noted how around nearly half of the world’s 7.6 billion population falls outside the countries covered in the licensing agreements. The group also claims that the agreements discourage generic competition in large middle-income countries, including Brazil, China and Mexico, which are not covered.
“Gilead still wants to control remdesivir,” Public Citizen said in a statement. “Gilead needs to get used to giving up that control.”
Knowledge Ecology International, another advocacy group, also questioned whether the five companies would be able to make enough remdesivir to supply countries in the southern hemisphere as the pandemic intensifies in South America and Africa.