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[e-drug] 27 generic manufacturers sign sublicence agreements for molnupiravir

E-DRUG: 27 generic manufacturers sign sublicence agreements for molnupiravir
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Dear colleagues,

I am pleased to let you know that today we announced the signing of 
sublicensing agreements with 27 generic manufacturers for the manufacturing of 
the oral COVID-19 antiviral medication molnupiravir and supply in 105 low- 
and-middle-income countries.

Here is our statement as published on our website: 
https://medicinespatentpool.org/news-publications-post/27-generic-manufacturers-sign-agreements-with-mpp-to-produce-molnupiravir

Geneva - The Medicines Patent Pool (MPP) announced today that it has signed 
agreements with 27 generic manufacturing companies for the manufacturing of the 
oral COVID-19 antiviral medication molnupiravir and supply in 105 low- 
and-middle-income countries (LMICs). The sublicence agreements are the result 
of the voluntary licensing agreement signed by MPP and MSD, a trade name of 
Merck & Co., Inc, Kenilworth, NJ, USA, in October 2021 to facilitate affordable 
global access for molnupiravir, that MSD is developing in partnership with 
Ridgeback Biotherapeutics.

The non-exclusive sublicences allow generic manufacturers to produce the raw 
ingredients for molnupiravir and/or the finished drug itself. The companies 
that were offered the sublicence successfully demonstrated their ability to 
meet MPP’s requirements related to production capacity, regulatory compliance, 
and the ability to meet international standards for quality-assured medicines. 
Five companies will focus on producing the raw ingredients, 13 companies will 
produce both raw ingredient and the finished drug and 9 companies will produce 
the finished drug. The companies span 11 countries, Bangladesh, China, 
Egypt/Jordan, India, Indonesia, Kenya, Pakistan, South Africa, South Korea, and 
Vietnam.

While MSD negotiated an agreement with MPP that establishes the terms and 
conditions, the requests for sublicences from generic producers were reviewed 
solely by MPP and presented to MSD. Neither MSD, Ridgeback Biotherapeutics nor 
Emory University, which invented the drug, will receive royalties from sales of 
molnupiravir from the MPP sublicensees while COVID-19 remains classified as a 
Public Health Emergency of International Concern by the World Health 
Organization (WHO).

'We are encouraged by the large number of new and existing partners that have 
moved quickly to secure a sublicence for molnupiravir through MPP,'� said 
Charles Gore, MPP Executive Director. 'This is a critical step toward ensuring 
global access to an urgently needed COVID-19 treatment and we are confident 
that, as manufacturers are working closely with regulatory authorities, the 
anticipated treatments will be rapidly available in LMICs.'�

'Accelerating broad, affordable access to molnupiravir has been a priority for 
MSD from the start, which led us to partner with MPP on a licensing agreement 
to expand access to quality-assured generic versions of molnupiravir, subject 
to local regulatory authorisation,'� said Paul Schaper, Executive Director, 
Global Public Policy, MSD. 'We are pleased to see this vision come to life, 
with strong geographic diversity in MPP's selected generic manufacturing 
sublicensees.'�

More on MPP's licence on molnupiravir and on the sublicence agreements : 
https://medicinespatentpool.org/licence-post/molnupiravir-mol

Best regards
Sophie

Sophie Thievenaz 
Communications Manager 
Medicines Patent Pool
Geneva, Switzerland
sthievenaz@medicinespatentpool.org
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