Gilead signs licenses for generic companies to make and sell remdesivir in 127 countries

Seeking to blunt concerns about access to its remdesivir treatment for Covid-19, Gilead Sciences (GILD) signed deals with five generic companies in India and Pakistan to manufacture and distribute the experimental medicine to 127 countries.

Under the agreements, the companies can set their own prices, but will not have to pay royalties to Gilead until the World Health Organization declares an end to the public health emergency for the novel coronavirus, or until another medicine or vaccine is approve to treat or prevent Covid-19. The companies include Cipla, Hetero Labs, Jubilant Lifesciences, Mylan, and Ferozsons.

The arrangements are formally called non-exclusive voluntary licenses, which is a similar approach Gilead has taken in the past in response to pressure to widen access to its hepatitis C medicines. In this instance, the deals cover mostly low-income and lower-middle income countries, but also some upper-middle- and high-income countries that Gilead said face significant obstacles to access.

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The move follows the release of preliminary trial results which indicated remdesivir can successfully treat serious cases of Covid-19. The disclosure prompted the Food and Drug Administration quickly authorized emergency use for hospitals. For the moment, Gilead plans to eventually donate 1.5 million doses, which could cover between 140,000 and 280,000 patients, depending on dosing.

The news ignited intense global interest, but also a new round of concern over access to Covid-19 treatments. This reflects the fact both that much of the current supply of the drug is earmarked for the U.S. and that Gilead has sparred with many countries and patient advocacy groups in the past over access to its HIV and hepatitis C treatments.

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Although Gilead has previously issued voluntary licenses to generic companies for some of its other medicines, the company has still encountered pushback over criticism that its efforts simply did not go far enough, since some countries with battered health care systems were excluded. But as noted previously, a new executive team is trying to get ahead of critics by pursuing far-reaching deals with remdesivir.

For the moment, it is unclear the extent to which remdesivir may become a standard of care, since full study results have not yet been released. But Gilead is anticipating worldwide demand for the treatment and looking to strike production deals with still other companies in order to make the medicine available in wealthier countries not covered by the new licensing agreements.

Gilead shares fell about 3.5%, shaving roughly $3 billion off its market cap.

Despite the licensing effort, Gilead encountered some criticism over its latest deals.

Public Citizen, the consumer group, noted that nearly half of the world’s population, or about 3.7 billion people, fall outside the licensing territories. The organization also argued the licensing deals will “discourage generic competition in large middle-income countries, such as Brazil, China and Mexico, where treatment needs may be especially serious.” Instead, Public Citizen urged Gilead to donate its patent and technology to the public domain.

Meanwhile, one academic expressed disappointment over what he called a lack of global coverage, since the licensing agreements make it unlikely the Indian government would issue so-called compulsory licenses to allow other companies to make and export versions of remdesivir. Under a World Trade Organization agreement, governments may grant such a license to a public agency or a generic drug maker, allowing it to copy a patented medicine without the consent of the brand-name company that owns the patent

Such a development for remdesivir “looks extremely unlikely, with key Indian firms entering into partnership with Gilead,” said Ken Shadlen, a political scientist at the London School of Economics, who studies the global pharmaceutical industry and patent issues. “I can’t see that happening.”

Instead, more widespread global supplies would have to come from another country that is willing to issue a compulsory export license and also has large domestic pharmaceutical companies with sufficient production capacity. “Will that happen? There aren’t that many candidates, and it seems unlikely,” said Shadlen.

“Of course, this is all predicated on the assumption that remdesivir is easy to reverse-engineer, as was the case with small-molecule AIDS drugs, so the barriers to production are largely legal. If the drug is as difficult to produce as Gilead says, then it’s not clear what compulsory licenses will accomplish, anyway. We’re still learning a lot about the drug itself.”