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26 March 2020Big PharmaRory O'Neill

Gilead backs away from antiviral monopoly after criticism

Gilead Sciences has agreed to drop the lucrative “orphan drug” designation for an antiviral touted as a potential coronavirus treatment, after criticism from activists and politicians including Bernie Sanders.

Earlier this week, it emerged that Gilead’s remdesivir had been granted orphan drug status by the US Food and Drug Administration (FDA), meaning the company would enjoy an effective monopoly for seven years.

Now,  Gilead says it has asked the FDA to withdraw the designation, and that it was “waiving all benefits” associated with it.

Orphan drug status is reserved for treatments for rare diseases that are often considered by drugmakers to be less profitable investments than drugs for more common illnesses.

With it, a drugmaker enjoys various incentives including tax breaks and seven years of marketing exclusivity on the orphan drug.

A ‘rare disease’, for the purpose of designating orphan drugs, is considered to be one that affects fewer than 200,000 people.

There are currently 54,453  confirmed cases of COVID-19 in the US, although this is thought to be much higher in reality, and expected to surge in the coming days and weeks.

Initially developed as an ebola medicine, some doctors have reported positive outcomes using remdesivir to treat the coronavirus behind the current COVID-19 pandemic. Several clinical trials to study the drug's safety and efficacy for COVID-19 treatment are currently underway.

Remdesivir has not yet been approved for use as a coronavirus treatment anywhere, and orphan drug status does not mean a drug has been cleared as safe.

But given the potentially lucrative advantages the designation confers on the owner of an orphan drug, critics such as the IP-focused NGO Knowledge Ecology International accused Gilead of  “morbid calculus” and attempting to profit off of the coronavirus pandemic.

Bernie Sanders demanded that US President Donald Trump stop the “corporate giveaway” to Gilead, which received public funding to develop the antiviral.

In a  statement, the Democratic Party presidential candidate said that it was “truly outrageous that after taxpayers put tens of millions of dollars into developing remdesivir, Trump’s FDA is exploiting a law reserved for rare diseases to privatise a drug to treat a pandemic virus”.

“Now is not the time for profiteering in the pharmaceutical industry. Now is the time to bring our scientists together to develop and produce the best treatment for the coronavirus as quickly as possible,” Sanders added.

Explaining its latest request to the FDA, Gilead said it was confident that it could “maintain an expedited timeline in seeking regulatory review of remdesivir without the orphan drug designation”.

Gilead did not reference the public criticism in its statement, but said it “recognises the urgent public health needs posed by the COVID-19 pandemic”.

“The company is working to advance the development of remdesivir as quickly as possible, and will provide updates as they become available,” the Gilead statement said.

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More on this story

Big Pharma
31 March 2020   Gilead Sciences says it is expanding access to its experimental antiviral remdesivir for treatment of COVID-19, albeit on a limited basis.
Big Pharma
2 April 2020   Almost 150 health and poverty activist campaigns, including Médecins Sans Frontières, have urged Gilead Sciences to waive patent and exclusivity rights for potential COVID-19 treatment remdesivir.
Big Pharma
15 April 2020   An association representing Indian cancer patients has asked the country’s government to cancel Gilead Sciences’ patents on remdesivir, the experimental antiviral which is hoped can be used to treat coronavirus.

More on this story

Big Pharma
31 March 2020   Gilead Sciences says it is expanding access to its experimental antiviral remdesivir for treatment of COVID-19, albeit on a limited basis.
Big Pharma
2 April 2020   Almost 150 health and poverty activist campaigns, including Médecins Sans Frontières, have urged Gilead Sciences to waive patent and exclusivity rights for potential COVID-19 treatment remdesivir.
Big Pharma
15 April 2020   An association representing Indian cancer patients has asked the country’s government to cancel Gilead Sciences’ patents on remdesivir, the experimental antiviral which is hoped can be used to treat coronavirus.