* WHO-led scheme pencils in $320 mln to buy antibodies by
* Drug to be produced at Fujifilm plant in Denmark -
* Dexamethasone also a priority for WHO against COVID
* Remdesivir omitted from list of priority drugs
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
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.
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
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
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
Unitaid confirmed the scheme had not procured or funded
remdesivir, which was initially trialed against Ebola. It did
not comment on why remdesivir did not appear among priority
treatments in the document.
Remdesivir has been authorized 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)