* Deal negotiated by U.N.-backed agency to expand output of
* Nearly 30 firms to sell low-cost molnupiravir in 105
* Asian, African makers may sell at $20, no royalties for
BRUSSELS, Jan 20 (Reuters) - Nearly 30 generic drugmakers in
Asia, Africa and the Middle East will make cheap versions of
Merck & Co's COVID-19 pill, under a landmark U.N.-backed
deal to give poorer nations wider access to a drug seen as a
weapon in fighting the pandemic.
Merck's early greenlight to production of its anti-viral
pill molnupiravir by other companies during the pandemic is a
rare example in the pharmaceutical sector, which usually
protects its patented treatments for longer periods.
However, there are questions about molnupiravir which has
shown low efficacy in trials and has raised concerns for
side-effects, and lengthy procedures for appovals may delay
supplies in many poorer nations for months.
Under the deal, negotiated by the U.N.-backed Medicines
Patent Pool (MPP) with Merck, the U.S. company will not receive
royalties for the sale of the low-cost version of the pill while
the pandemic continues.
The MPP said the deal stipulated the pill would be
distributed to 105 less-developed nations.
A molnupiravir course of 40 pills for five days is expected
to cost about $20 in poorer nations, an MPP official involved in
the talks with drugmakers told Reuters, citing initial estimates
from drugmakers, which are subject to change.
That is far below the $700 per course the United States
agreed to pay for an initial delivery of 1.7 million courses,
but twice as high as first estimated by the World Health
Organization (WHO)-backed programme to procure COVID-19 drugs
and vaccines for the world.
The new agreement allows 27 generic drugmakers from India,
China and other countries in Africa, Asia and the Middle East to
produce ingredients and the finished drug.
An MPP spokesperson said deliveries from some firms covered
by the deal could start as early as February. However, that will
be subject to regulatory approval.
While molnupiravir is in use in the United States after
approval in December, some other Western countries have
cancelled or are reconsidering orders after the drug showed low
efficacy in trials.
Molnupiravir has also not been approved by the World Health
Organization, which makes its sale at the moment not possible in
most developing countries with limited regulatory resources for
The drug can already be sold in India, after it received
emergency approval by the national regulator, but it is not
currently recommended for use because of safety risks. https://www.reuters.com/world/india/india-health-official-says-merck-covid-pill-has-major-safety-concerns-2022-01-05
NO ROYALTIES, FOR NOW
The developers of molnupiravir, which alongside Merck are
U.S. firm Ridgeback Biotherapeutics and Emory University, will
not receive royalties for the sale of the low-cost versions made
by generic drugmakers while COVID-19 remains classified as a
Public Health Emergency of International Concern by the WHO.
Bangladesh's Beximco Pharmaceuticals, India's
Natco Pharma, South Africa's Aspen Pharmacare Holdings
and China's Fosun Pharma are among generics
firms that will produce the finished product.
Other companies, including India's Dr Reddy's Laboratories
, had struck earlier deals with Merck for the
production of molnupiravir. Dr Reddy's will sell
molnupiravir at 1,400 rupees ($18.8) per course.
The MPP spokesperson said there was no firm estimate yet of
the likely output from generics makers covered by the deal, but
that poorer nations' demand was expected to be largely covered.
The MPP works to increase access to life-saving medicines
for poorer countries. It also has an agreement with Pfizer for
the sub-licensing of its COVID-19 pill paxlovid to generics
(Reporting by Francesco Guarascio @fraguarascio
Editing by David Goodman, Mark Potter and Susan Fenton)