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PrEP activists accuse pharmaceutical company Gilead of intentionally delaying HIV medication

Patrick Kelleher December 6, 2019
HIV PrEP

PrEP, sometimes known by the brand name Truvada, can stop new HIV transmissions. (Getty)

PrEP activists in the United States have accused pharmaceutical company Gilead Sciences of intentionally delaying development of a treatment for the virus.

The PrEP4All Collaboration claimed yesterday (December 5) that Gilead Sciences deliberately put off developing a drug called tenofovir alafenamide (TAF) which is used to treat HIV. It is also used in Descovy, one of two approved PrEP drugs.

This week, PrEP4All filed an emergency petition with the United States Patent and Trademark Office (PTO) challenging Gilead Sciences’ request to extend its patent monopoly on the drug. They claim that the company – which makes PrEP pill Truvada – intentionally put off developing TAF for almost a decade because they thought it was safer than other HIV medications.

The group claims that Gilead Sciences’ then-chief operating officer John Milligan admitted in 2011 at an investor’s conference that it had paused development on TAF. He allegedly claimed that it would be safer than tenofovir disoproxil fumarate (TDF), an ingredient in Gilead’s PrEP drug Truvada.

PrEP4All claims that Milligan admitted to pausing development of TAF so Gilead could maximise its profits on TDF.

The advocacy organisation is arguing that, if it weren’t for the alleged decade-long delay, Gilead Sciences would have no claim to a patent extension on the drug. Therefore, they are calling for the company’s patent extension to be denied. If the US Patent and Trademark Office rules in favour of PrEP activists, a generic version of TAF could come onto the market as soon as 2022.

Gilead reportedly made more than $9 billion last year alone from TAF. If the company is awarded the patent extension it is seeking, it will stand to make billions more in the coming years.

PrEP advocacy group claims that Gilead Sciences ‘intentionally’ delayed developing HIV drug TAF.

In its petition, PrEP4All alleges that Gilead didn’t disclose details of the supposed “intentional” TAF delay to the PTO.

The group alleges that Gilead was developing TAF as far back as 2001 but discontinued its work on the drug in 2004. They later resumed development of TAF in 2010, and the first TAF containing drug was not approved until 2015 – 14 years after development began.

“The Trump administration should be reprimanding Gilead for intentionally delaying the development of a drug it thought was safer, not rewarding it with more than $30 billion worth of patent term extension,” said James Krellenstein, co-founder of PrEP4All.

“If the Trump administration is serious about lowering drug prices and ending the HIV epidemic, it must stop Gilead’s attempt to extend its ability to price gouge the American people by delaying the development and introduction of drugs it now claims are safer.”

Senator Bernie Sanders also hit out at Gilead in a statement.

“It is an absolute disgrace that in America, a greedy drug company like Gilead can deprive hundreds of thousands of Americans of lifesaving HIV medicine to extract more profit, then lie about it, and then have the audacity to ask the U.S. government to award it with a longer monopoly to reap tens of billions more in profits,” Sanders said.

“I applaud these grassroots activists who are opposing an obscene giveaway for corporate criminality. The US Patent and Trademark Office must not reward Gilead for its illegal and immoral behaviour.”

In a statement provided to PinkNews, a Gilead spokesperson denied claims that they intentionally delayed development of TAF.

“With regard to the petition, we strongly believe it lacks merit and is in conflict with the PTE statute,” the statement said.

“For more than three decades, Gilead has been committed to developing and improving upon therapies that address unmet needs for people living with HIV. Ongoing collaboration with, and input from, the medical and advocacy communities have always played a key role in helping inform our development programs and decisions.

“Patient safety is of foremost importance to us and any implication that Gilead delayed the development of a drug known to be safer than TDF is false.”

US government announced new HIV preventative programme earlier this week.

News of the PrEP4All’s emergency petition comes just days after the US Department of Health and Human Services announced a new programme, called ‘Ready, Set, PrEP,’ which will provide free HIV-preventing medication to 200,000 uninsured people.

As part of the ‘Ready, Set, PrEP’ scheme, the drug will be made available at no cost to at-risk people without insurance coverage from CVS Health, Walgreens, and Rite Aid pharmacies.

The US government’s plans come just weeks after they lodged a patent infringement lawsuit against Gilead Sciences and accused the  company of “wilfully and deliberatively” infringing its own patents on PrEP.

“As a result of such infringement, Gilead has profited from research funded by hundreds of millions of taxpayer dollars and reaped billions from PrEP through the sale of Truvada and Descovy [a newly-approved PrEP drug],” the government said in a statement.

More: gilead sciences, HIV, PrEP, PrEP4All

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