Gates Foundation to spend $120 mln to speed access to generics of Merck COVID-19 pill (updated)

Global Health

20/10/2021 13:28

(Adds details)
    By Julie Steenhuysen and Michael Erman
    Oct 20 (Reuters) - The Bill & Melinda Gates Foundation said
on Wednesday it would spend up to $120 million to kick-start
development of generic versions of Merck & Co's  MRK.N  oral
COVID-19 treatment to help ensure lower-income countries have
equal access to the drug.
    The aim is to reduce the gap between when wealthy countries
have access to the antiviral medicine, molnupiravir, and when
the rest of the world can benefit from it.
    "To end this pandemic, we need to ensure that everyone, no
matter where they live in the world, has access to life-saving
health products," Melinda French Gates, co-chair of the Gates
Foundation, said in a statement.
    The Gates Foundation investment will be used to help 
drugmakers ramp up production of generic molnupiravir, as well
as support regulatory filings and prepare local markets, Trevor
Mundel, the foundation's president of Global Health, said in an
interview.
    Initial data from a clinical trial https://www.reuters.com/business/healthcare-pharmaceuticals/mercks-covid-19-pill-cuts-risk-death-hospitalization-by-50-study-2021-10-01
 on Merck's experimental pill suggest it can halve the risk of
serious disease and death from COVID-19 when given early in the
illness. 
    Mundel said the funding would act as a bridge to get the
manufacturing process started. Ultimately, he estimated the
total cost to launch a generic version of Merck's antiviral at
up to $500 million dollars. "That's where the global funders are
going to have to come in," he said. 
    
    INDIAN DRUGMAKERS
    The foundation has sent out requests for proposals from the
eight Indian drugmakers already licensed by Merck to produce
generics of the medicine, Mundel said. They include Aurobindo
Pharma  ARBN.NS , Cipla Ltd  CIPL.NS , Dr. Reddy’s Labs
 REDY.NS , Emcure Pharmaceuticals, Hetero Labs, Sun
Pharmaceuticals  SUN.NS  and Torrent Pharmaceuticals  TORP.NS .
    The foundation also has been in talks with Merck about
extending its licences to other generic drugmakers, including
some in Africa. 
    The Indian companies have yet to disclose production plans.
Mundel estimates they could produce up to 10 million doses a
month, vastly more than the 20 million doses Merck has projected
it will produce next year.
    Initial doses of the generic drug could be ready for launch
in the first quarter of 2022, if approved.
    Merck has been producing the drug for months and has filed
for U.S. emergency use authorization (EUA) with the U.S. Food
and Drug Administration.
    An advisory panel review of the medication is scheduled for
Nov. 30. If granted an EUA, the drug could be available in early
December.
    As it has done with some HIV drugs, the Gates Foundation has
worked with partners to simplify aspects of the drug synthesis
process, Mundel said, reducing the number of steps involved and
cutting the cost of goods. At least five of the authorized
generic drugmakers have said they intend to use this simplified
manufacturing process. 
    The Gates Foundation has had its eye on molnupiravir since
March 2020, Mundel said, when Emory University licensed it to
Ridgeback Biotherapeutics, which later struck a deal with Merck.
    He said the pill would be much easier to administer in low-
and middle-income countries than injectable antivirals. It could
also be useful should a new virus variant arise that defeats
vaccine immunity, he said.

 (Reporting by Julie Steenhuysen in Chicago and Michael Erman in
New Jersey; additional reporting by Bhargav Acharya in
Bengaluru; Editing by Bill Berkrot, Clarence Fernandez and
Gareth Jones)
 ((Bhargav.Acharya@thomsonreuters.com;))