On 16 November 2021, Pfizer Inc., the US multi-national pharmaceutical, and the Medicines Patent Pool (MPP), a United Nations-backed public health organization which aims to increase access to life-saving medicines for low- and middle-income countries, announced the signing of a voluntary license agreement for the local manufacture of Pfizer’s COVID-19 oral antiviral treatment candidate PF-07321332.
PF-07321332 is a developmental antiviral therapy, designed for oral administration in combination with low dose ritonavir at the first sign of a COVID-19 infection or a reported exposure. Pfizer initiated Phase 2/3 trials of PF-07321332 in July 2021, with approximately 1,219 adults participating, and has reported that its interim analysis showed an 89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of the start of symptoms.
Under the terms of this new license agreement, the MPP will be able to facilitate the production and distribution of Pfizer’s oral antiviral treatment candidate globally, by granting sub-licenses to qualified generic medicine manufacturers.
Ghana is included on the list of countries covered by this agreement and any qualified generic medicine manufacturers that are granted sub-licenses would be able to manufacture and supply PF-07321332 in Ghana. Sub-licensees would be permitted to manufacture both the API and the finished formulations of PF-07321332.
The license agreement provides that Pfizer will waive royalties on sales in all countries covered by the agreement while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization. Royalties are waived entirely for “Lower Income Countries”, but Ghana is classed as a “Lower-Middle Income Country”, so royalties would be payable after COVID-19 ceases to be classified as a Public Health Emergency of International Concern.
The MPP is inviting Expressions of Interest from interested generic manufacturers through its online portal, which can be accessed here. The deadline for Expressions of Interest is 6 December 2021.
In order to qualify, licensees must obtain approval from the World Health Organization (WHO) Pre-qualification, or a Stringent Regulatory Authority (SRA). Where such approval is not yet available, provisional or emergency use authorisations available through WHO or an SRA may be considered.
Applicants will need to provide details of their capacity, capabilities and track-record for manufacturing quality-assured medicines, their R&D programme, regulatory compliance and financials. Potential sublicensees are also asked to provide specific plans for the products they wish to license, covering development, manufacturing, regulatory plan, distribution and predicted investments. Further details on the application process and the assessment criteria are available here.
Any generic manufacturer wishing to submit an expression of interest would be well advised to seek legal advice to support the application process; review the terms of the license agreement and form of sublicense (which include, amongst other things, customary compliance requirements in respect of international cGMP standards); and the regulatory framework for manufacture and distribution of pharmaceutical products in Ghana.
We hope this licensing arrangement can help deliver equitable access to COVID-19 treatments, which could play a pivotal role in winning the fight against the global threat in West Africa.