[Ip-health] Financial Times: Gilead asks to rescind special status for potential coronavirus drug

Thiru Balasubramaniam thiru at keionline.org
Wed Mar 25 12:43:23 PDT 2020


Gilead asks to rescind special status for potential coronavirus drug
Drugmaker had come under fire for ‘orphan’ ranking that conferred pricing
and tax benefits

Donato Paolo Mancini in London, Hannah Kuchler in New York and Kiran Stacey
in Washington 28 MINUTES AGO

Gilead Sciences has asked US regulators to rescind “orphan drug” status for
its potential coronavirus medicine, amid criticism it would be abusing a
process reserved for treatments for rare diseases in the face of a sweeping

The company’s unusual U-turn on its potential coronavirus candidate
Remdesivir comes just two days after Gilead disclosed it had been granted
the status by the US Food and Drug Administration. The drugmaker said on
Wednesday that it was waiving all benefits of the status — which include
significant tax incentives and control over prices for at least seven years
in a de facto monopoly.

On Tuesday the Financial Times reported that activists had slammed the
designation, calling it “morbid calculus” in the face of a
rapidly-spreading pandemic. Orphan drugs are intended for diseases
affecting up to 200,000 people in the US. Almost 60,000 people are infected
with coronavirus in the US, but the number is likely to be an
underestimate. Globally, more than 436,000 people have been infected.

“Gilead is confident that it can maintain an expedited timeline in seeking
regulatory review of remdesivir, without the orphan drug designation,” the
company said on Wednesday.

Activists had criticised the timing of the move, which was disclosed hours
after the drugmaker said it would be limiting some of its compassionate-use

“Gilead acknowledged it did not file for orphan status until early March,
after it was clear it was a pandemic,” said Jamie Love, founder of
intellectual property advocacy group Knowledge Ecology International.

“Gilead’s decision can fix one problem, but we don’t know what other drugs
will qualify for orphan status. The FDA made the mistake, and the FDA
procedures need to be fixed,” added Mr Love.

The FDA’s decision to grant orphan drug status had prompted anger in
Congress, where some US lawmakers expressed concern that the company could
use it to make remdesivir unaffordable to many coronavirus patients.

Before Gilead made its reversal, Patty Murray, the most senior Democrat on
the Senate health committee, said the FDA decision had raised “some
concerning flags”, adding that she planned to push the agency as to why it
had made the determination.

Many analysts believe remdesivir, originally developed to treat Ebola, is
one of the best bets for treating Covid-19. Studies in animals have also
shown it is successful against other coronaviruses.

Data from a small study using the drug to treat Covid-19 patients in China
is expected to be released in the coming weeks. Large trials of hundreds of
patients have been started by the World Health Organization and the US
National Institutes of Health, among others.

Gilead’s U-turn comes after AbbVie, a US pharma company that makes a
combination of HIV drugs that are also being tested against the virus,
waived all intellectual property rights on the combination worldwide,
paving the way for lower-priced generics to flood the market.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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