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EXCLUSIVE-WHO-led COVID drug scheme doubles down on antibodies, steroids and shuns remdesivir

* WHO-led scheme pencils in $320 mln to buy antibodies by Feb

* Drug to be produced at Fujifilm plant in Denmark - document

* Dexamethasone also a priority for WHO against COVID

* Remdesivir omitted from list of priority drugs (Adds detail about Roche)

BRUSSELS, Nov 5 (Reuters) - A World Health Organization-led scheme to supply COVID-19 drugs to poor countries is betting on experimental monoclonal antibody treatments and steroids but shunning Gilead’s remdesivir therapy, an internal document shows.

The Oct. 30 WHO draft document seen by Reuters says priorities are to secure monoclonal antibodies in a tight market and to boost distribution of cheap steroid dexamethasone, of which it has already booked nearly 3 million courses of treatment for poorer countries.

Monoclonal antibodies are manufactured copies of antibodies created by the body to fight an infection, and drugmakers including Roche and Novartis confirmed initial contact with the WHO scheme.

The paper, which for the first time outlines how the scheme would spend donors’ money, does not cite remdesivir among priority drugs - a significant omission as the antiviral is the only other medication alongside dexamethasone approved across the world for treating COVID-19.

Gilead Science said the WHO scheme had not funded its COVID-19 trials and had never approached the firm for the possible inclusion of remdesivir in its portfolio.

The drug-supply scheme is one of the four pillars of the so-called ACT Accelerator, a WHO-led project which also seeks to secure COVID-19 vaccines, diagnostics and protective gear for poorer countries by raising more than $38 billion by the beginning of 2022.

“Immediate priorities for the (therapeutics) pillar are intensifying efforts on monoclonal antibodies while scaling up dexamethasone use,” says the document, which is subject to change but due for publication as soon as Friday.

The scheme, co-led by the Wellcome Trust, a charity, and Unitaid, a health partnership hosted by the WHO, urgently needs $6.1 billion, $750 million of which by February, out of a total ask of $7.2 billion.

More than half the cash would be used to procure and distribute monoclonal antibodies, the document shows, calling these therapeutics “game-changing” but in short supply.

No monoclonal antibody has, so far, been approved against COVID-19, but the WHO scheme has already invested in research and secured production capacity at a Fujifilm Diosynth Biotechnologies plant in Denmark.

Fujifilm didn’t immediately comment.

The scheme wants $320 million to make antibodies in that facility, the document says, estimating that would be enough to secure 4 million antibody courses, at about $80 per course.

A spokeswoman for Unitaid confirmed that it wanted to raise and invest $320 million in securing monoclonal antibodies but said commercial deals were confidential.

Another $110 million would be used for regulatory approval and other market preparation procedures for monoclonal antibodies in poorer countries, the document shows, while $220 million would fund clinical trials.

‘AFFORDABLE PRICE’

Among companies developing experimental monoclonal antibodies against COVID-19 are U.S. firms Eli Lilly and Regeneron. U.S. President Donald Trump got their antibodies in October after testing COVID-19 positive.

Eli Lilly has already agreed to produce antibodies at the Fujifilm plant from April and make them available at “an affordable price” to poorer countries, a company spokeswoman said.

A U.S. government-run trial of Lilly’s drug was paused in mid-October over safety concerns, but other trials continue and the U.S. administration last week sealed a $375-million supply deal.

It is unclear how and whether the WHO scheme will raise the money needed for the antibody project.

Roche, which has partnered with Regeneron to make up to 2 million doses of the so-called REGN-COV2 antibody annually by 2021, has had “preliminary discussions” with the ACT Accelerator over an access plan.

“These discussions were in the context of development and production,” a Roche spokesman said in an email. “It is too early to speculate on future decisions, but we will continue working with them and other groups regarding REGN-COV2.”

Novartis, which expects results soon from a trial of its arthritis treatment canakinumab against COVID-19, said on Thursday it received a request several days ago from the WHO scheme seeking information about medicines to tackle the coronavirus. Novartis also makes dexamethasone.

Despite being short of funds, the WHO drugs-supply scheme aims to distribute hundreds of millions of courses of COVID-19 drugs to poorer countries by 2022.

Apart from monoclonal antibodies and dexamethasone, it is also eyeing other experimental drugs, including new antivirals and repurposed drugs.

The scheme would spend another $100 million to seal deals with unspecified drugmakers from mid-2021, the document says, and next year plans to invest another $4.4 billion on drugs that succeed in clinical trials.

The Unitaid spokeswoman said dexamethasone and its alternative, hydrocortisone, were the most promising among repurposed drugs.

Unitaid confirmed the scheme had not procured or funded remdesivir, which was initially trialled against Ebola. It did not comment on why remdesivir did not appear among priority treatments in the document.

Remdesivir has been authorised in multiple countries to treat COVID-19. However, preliminary findings of a WHO-sponsored trial conluded the antiviral had little or no benefit, contradicting previous positive trials.

Governments however continue to buy it, with Germany this week announcing a 150,000-plus dose purchase.. (Reporting by Francesco Guarascio @fraguarascio; additional reporting by John Miller in Zurich and Caroline Humer; editing by Nick Macfie)

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