UCL signs MSD licensing deal for investigational monthly HIV prevention pill
The licensing agreement will allow UCL to manufacture and supply generic alimatravir in African countries and other markets covered by the agreement, subject to successful clinical development and regulatory approval.
KENYA — Universal Corporation Limited (UCL), a Kenyan pharmaceutical manufacturer, has entered into a licensing agreement with MSD to manufacture and supply generic versions of alimatravir (MK-8527), an investigational once-monthly oral HIV-1 pre-exposure prophylaxis (PrEP) candidate.
The agreement forms part of MSD’s voluntary licensing programme, which has selected seven generic manufacturers globally to prepare for the potential production and supply of alimatravir in 129 low- and lower-middle-income countries.
UCL is one of three participating manufacturers based in Sub-Saharan Africa, alongside Aspen Pharmacare in South Africa and Quality Chemical Industries Limited (QCIL) in Uganda.
Preparing for potential production
The licensing agreement will allow UCL to manufacture and supply generic alimatravir in African countries and other markets covered by the agreement, subject to successful clinical development and regulatory approval.
MSD has established the manufacturing partnerships while Phase 3 development of alimatravir is still underway.
This approach gives participating manufacturers time to prepare production capacity, supply chains and other requirements before any potential regulatory approval.
Alimatravir is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) being evaluated as a potential once-monthly oral PrEP option for people at risk of HIV-1 infection.
The candidate is currently undergoing Phase 3 clinical evaluation as part of MSD’s HIV prevention programme.
If approved, the medicine could provide an alternative to existing HIV prevention approaches that require more frequent dosing.
However, its availability will depend on successful clinical trials and subsequent regulatory approvals.
UCL expands manufacturing role
For UCL, the agreement adds to its pharmaceutical manufacturing activities and its efforts to expand production capacity in Africa.
The company operates a WHO-prequalified manufacturing facility in Kenya and supplies medicines to more than 23 countries across Africa and other markets.
Palu Dhanani, Managing Director of UCL, said the company was proud to partner with MSD on an initiative that could expand access to a new HIV prevention option if the candidate receives regulatory approval.
He said UCL’s selection as one of three manufacturing partners in Sub-Saharan Africa demonstrates the growing capacity of the region’s pharmaceutical industry.
Dhanani added that the company’s participation would enable it to prepare manufacturing capabilities ahead of potential approval and support the supply of alimatravir at scale.
“We look forward to working with MSD and other partners to support equitable access to HIV prevention,” Dhanani said.
The agreement therefore places UCL among manufacturers preparing early for the potential commercialization of an investigational HIV prevention medicine, while MSD continues the clinical development and regulatory process for alimatravir.
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