MPP agreements allow generics production of Merck and Pfizer’s COVID-19 treatments

Generics/General | Posted 10/12/2021 post-comment0 Post your comment

In October and November 2021, Merck and Pfizer signed licensing agreements with the United Nation’s backed Medicines Patent Pool (MPP) to help increase access to their investigational COVID-19 oral antiviral treatment options. Respectively, these are molnupiravir and Paxlovid. Creating these royalty free licences will allow for generic versions of the drugs to be produced and distributed in approximately 100 low- and middle-income countries worldwide.

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MPP agreements
The announced MPP licensing agreements, which also include technology transfer, will remain royalty-free so long as the World Health Organization classifies the pandemic as a Public Health Emergency of International Concern.

Despite the potential of the Merck-MPP agreement, Médecins Sans Frontières (MSF) has expressed disappointment with the limitations of this license. This is because the license excludes many territories and nearly half of the world's population, including important upper-middle-income countries with strong manufacturing capacity, such as Brazil and China. In addition, MSF is concerned that the licences contain harmful provisions that undermining the right of generics companies to challenge patents to facilitate generic drug production.

Merck’s molnupiravir MPP agreement and other advances
Co-developed with Ridgeback Biotherapeutics, Merck’s investigational oral COVID-19 antivirals, molnupiravir, was backed by MPP in late October 2021. It has been stated that this will make the treatment available in over a hundred low- and middle-income countries. As a result of the agreement, Bangladesh's Beximco has now been granted permission to sell the first generic versions of the pill.

The MPP agreement announcement came months after Merck’s April 2021 announcement that it had signed non-exclusive voluntary licensing agreements with several Indian generic drugmakers to expand production of generic versions of the drug to increase its availability [1].

In addition, Merck is seeking emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for molnupiravir, as it has not yet been officially approved. On the other hand, the European Union's (EU) drug regulator has now also advised that molnupiravir (marketed as Lagevrio in the EU) should be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of their disease worsening.

Pfizer’s Paxlovid
In early November 2021, Pfizer announced that interim results of phase II/III studies show that their COVID-19 treatment, Paxlovid, leads to an 89% reduction in risk of COVID-19-related hospitalization or death, when compared to placebo in patients treated within three days of symptom onset [2].

By 16 November 2021, the company signed the agreement with MPP to make the treatment widely available in 95 low- and middle-income countries, which could facilitate access to 53% of the world's population.

In addition, Pfizer is also seeking EUA from FDA for Paxlovid to facilitate fast access to the drug that has not yet been approved.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Merck partners with Indian drugmakers to increase access to COVID-19 drug [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 10]. Available from: www.gabionline.net/pharma-news/Merck-partners-with-Indian-drugmakers-to-increase-access-to-COVID-19-drug
2. GaBI Online - Generics and Biosimilars Initiative. Pfizer and Merck COVID-19 antiviral progress [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 10]. Available from: www.gabionline.net/generics/news/pfizer-and-merck-covid-19-antiviral-progress

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