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

e-drug
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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

2

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

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

3

Traduction de ce communiqué :
https://medicinespatentpool.org/news-publications-post/27-generic-manufacturers-sign-agreements-with-mpp-to-produce-molnupiravir

Question : "le molnupiravir est-il un médicament essentiel" ?
Sur ce site de l'OMS, le groupe d'élaboration des lignes directrices de l'OMS (GDG) qui est composé d'un groupe d'experts mondiaux, de prestataires de première ligne et de patients partenaires et est indiqué que "D'autres traitements contre la COVID-19 actuellement à l'étude par l'OMS comprennent le molnupiravir, la fluvoxamine, le nirmatrelvir/ritonavir, la colchicine et les anticoagulants. Cette ligne directrice sera mise à jour si/quand de nouvelles preuves suffisantes le justifient. "
https://www.who.int/teams/health-care-readiness-clinical-unit/covid-19/therapeutics
Carinne Bruneton

27 fabricants de génériques signent des accords avec le MPP pour produire des versions à faible coût du médicament antiviral COVID-19 molnupiravir pour l'approvisionnement dans 105 pays à revenu faible et intermédiaire

20 janvier 2022

Genève – Le Medicines Patent Pool (MPP) a annoncé aujourd'hui avoir signé des accords avec 27 fabricants de génériques pour la fabrication du médicament antiviral oral COVID-19 molnupiravir et son approvisionnement dans 105 pays à revenu faible ou intermédiaire (PRFI). Les accords de sous-licence sont le résultat de l'accord de licence volontaire signé par MPP et MSD, un nom commercial de Merck & Co., Inc, Kenilworth, NJ, États-Unis, en octobre 2021 pour faciliter un accès mondial abordable au molnupiravir, que MSD développe en partenariat avec Ridgeback Biotherapeutics.

[https://medicinespatentpool.org/uploads/2022/01/map-of-phama-V6-1024x582.jpg\]

Les sous-licences non exclusives permettent aux fabricants de génériques de produire les ingrédients bruts du molnupiravir et/ou le médicament fini lui-même. Les entreprises qui se sont vu offrir la sous-licence ont démontré avec succès leur capacité à répondre aux exigences du MPP en matière de capacité de production, de conformité réglementaire et de capacité à respecter les normes internationales pour les médicaments de qualité garantie. Cinq entreprises se concentreront sur la production des ingrédients bruts, 13 entreprises produiront à la fois l'ingrédient brut et le médicament fini et 9 entreprises produiront le médicament fini. Les entreprises couvrent 11 pays, le Bangladesh, la Chine, l'Égypte/la Jordanie, l'Inde, l'Indonésie, le Kenya, le Pakistan, l'Afrique du Sud, la Corée du Sud et le Vietnam.

Alors que MSD a négocié un accord avec MPP qui établit les termes et conditions, les demandes de sous-licences des producteurs de génériques ont été examinées uniquement par MPP et présentées à MSD. Ni MSD, Ridgeback Biotherapeutics ni l'Université Emory, qui a inventé le médicament, ne recevront de redevances sur les ventes de molnupiravir des sous-licenciés du MPP, tandis que le COVID-19 reste classé comme une urgence de santé publique de portée internationale par l'Organisation mondiale de la santé (OMS).

"Nous sommes encouragés par le grand nombre de partenaires nouveaux et existants qui ont agi rapidement pour obtenir une sous-licence pour le molnupiravir via le MPP", a déclaré Charles Gore, directeur exécutif du MPP. « Il s'agit d'une étape cruciale pour garantir l'accès mondial à un traitement COVID-19 nécessaire de toute urgence et nous sommes convaincus que, comme les fabricants travaillent en étroite collaboration avec les autorités réglementaires, les traitements prévus seront rapidement disponibles dans les PRITI.

« Accélérer un accès large et abordable au molnupiravir a été une priorité pour MSD depuis le début, ce qui nous a conduit à nous associer au MPP sur un accord de licence pour étendre l'accès aux versions génériques de qualité garantie du molnupiravir, sous réserve d'une autorisation réglementaire locale », a déclaré Paul Schaper, directeur exécutif, Politique publique mondiale, MSD. « Nous sommes ravis de voir cette vision se concrétiser, avec une forte diversité géographique parmi les sous-licenciés de fabrication de génériques sélectionnés par MPP. »

En savoir plus sur la licence du MPP sur le molnupiravir et sur les accords de sous-licence<https://medicinespatentpool.org/licence-post/molnupiravir-mol&gt;