Gilead’s Remdesivir: Flexible Pandemic Access Agreements Paying Off

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Less than two months passed between the WHO’s official pandemic declaration and remdesivir’s emergency use authorisation in the United States in May 2020. Today, the intravenous antiviral, sold by Gilead Sciences under the brand name Veklury, has generated over USD 8 billion in sales.

 

Remdesivir’s success as a treatment for COVID – the product is currently authorised in over 50 countries and has received nods from leading regulators in Europe, the US, UK, and Japan – has relied on a carefully orchestrated marketing strategy.

In the EU, the California-based company first delivered the drug for free through a compassionate use program before signing a formal contract with the European Commission (EC) to secure six months’ worth of doses.

“We managed to deliver the product through a compassionate use program for the first six months, providing it for free from April until October 2020,” explained Valentino Confalone, Gilead’s general manager for Italy. “After that, with the joint procurement agreement signed with the EC, the situation eased, and we were able to meet demand,”

 

[Gilead] never thought of the product as a business opportunity, rather choosing to price it below what would have been considered a reasonable price from a cost-effectiveness point of view, so that everybody could have access

Valentino Confalone, Gilead Italy

 

“From a business perspective, remdesivir offset what Gilead lost in other therapeutic areas, although the company never thought of the product as a business opportunity, rather choosing to price it below what would have been considered a reasonable price from a cost-effectiveness point of view, so that everybody could have access; it was one of the reasons why Gilead was able to sign the joint procurement agreement (JPA) with the EC. It was an intense period, but we managed to ensure continuity of supply for patients in need,” Confalone said.

He remembers that period, mid-2020, as one full of challenges due to a lack of clinical data: “Especially in the beginning, we faced challenges related to discrepancies in the data available at the time to the WHO, and to the US and European authorities. Indeed, questions were raised in the months following the JPA about the effectiveness of the product, but subsequent data from trials proved that it was the correct decision.”

Indeed, the fast authorisation process raised concerns, some arguing that the FDA “held no advisory meeting on the antiviral, and the European Union signed the contract without knowing of a failed trial.”

 

A similar and familiar approach in the Middle East

The product’s journey in less-developed regions was not so different. One good example is the Middle East, where Gilead has had a direct presence for just eight years. There, the firm donated 25,000 doses during the first months of the pandemic.

Middle East GM Frederico Silva recently shared his experiences around remdesivir and COVID with PharmaBoardroom. “We engaged early on with the health authorities in the region to establish a regulatory pathway in most of the Middle East countries to allow the availability of Veklury and secure uninterrupted supply. We also collaborated with healthcare providers, the medical community and clinicians to share information and support the public health response to this pandemic.”

Silva continued, “We received emergency use authorisation from several regulatory agencies in the region as the pandemic accelerated the development of this mechanism. Very early on, Gilead received seven conditional approvals, full marketing authorisation in the UAE, and in Saudi Arabia. These emergency use authorisations ensured that the product has been broadly available to those in need,” Silva said.

Thanks to those regional efforts, Gilead became the early bird that caught the worm, pocketing USD 5.5 billion from Veklury in 2021, according to public documents. While the company expects that sales from the drug will fall dramatically this year – as more antiviral options become available – to around USD 2 billion, it has consolidated its position as a blockbuster.

The bet placed by Gilead with Veklury, supplying the product for free and agreeing later to creative agreements, was not new for them. According to Valentino Confalone, “in some ways, the case of remdesivir resembles what happened with sofosbuvir [hepatitis C], where initial concerns were raised about the price tag but history proved that the product was not only incredibly valuable, but also correctly priced since it saved health systems millions by helping to prevent Hepatitis C patients from progressing to liver failure.”

“Even the Italian Ministry of Health has publicly expressed that sofosbuvir was one of the best investments they have made in decades due to the clinical and overall economic benefit; there is data showing that the investment is recovered in six years,” he revealed, adding that Italy played a key role in understanding the value of remdesivir as one of the first global epicentres of the pandemic.

 

The right pipeline at the right time

To those looking from the outside at Veklury’s rapid development and fast-track authorisations, not even two months after the WHO declared a global pandemic, it might seem like a stroke of luck. But to those on the inside, it was a matter of course

 

Gilead has been focusing its R&D efforts on virology for over 30 years, particularly on the treatment and prevention of HIV and HCV, giving us a deep understanding of viruses

Frederico Silva, Gilead Middle East

 

“It is important to point out that Gilead has been focusing its R&D efforts on virology for over 30 years, particularly on the treatment and prevention of HIV and HCV, giving us a deep understanding of viruses… we were able to pivot quickly,” outlined Silva.

His “not-an-overnight success” reasoning follows that of Gilead’s CEO, Daniel O’Day, who in late 2020 explained that it was the “result of decades of investment in research and very importantly, billions in antiviral research. Remdesivir is a story that started about 10 years ago due to our investments in emerging viruses. That level of investment and preparedness allowed us to move very, very quickly [in the case of COVID-19].”

Originally approved to treat patients requiring hospitalisation, remdesivir can now be administered to high-risk patients outside the hospital in the US. The drug was first clinically evaluated for the Ebola virus in 2016. Even today, Veklury remains the only COVID-19 treatment fully approved by the United States FDA.


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