Johannesburg, South Africa – Aspen Pharmacare Holdings Limited (“Aspen”) today announced the execution of a voluntary licensing agreement with MSD (a subsidiary of Merck & Co., Inc Rahway, NJ, USA) (“MSD”), providing Aspen with rights to develop, manufacture and commercialise MK-8527 (alimatravir”) a late stage investigational, once-monthly, long-acting oral medicine for the prevention of HIV-1.
The agreement marks an important step in Aspen’s commitment to improving access to new medicines in Africa and strengthening local pharmaceutical manufacturing capabilities.
Stephen Saad, Aspen Group Chief Executive said, “This agreement reflects Aspen’s commitment to expanding access to important medicines across Africa. Through our agreement with MSD, we have the opportunity to support the future supply of an innovative HIV prevention option while strengthening local pharmaceutical manufacturing and healthcare resilience across the continent.”
Under the agreement, Aspen will receive a technical package from MSD, together with licensing rights covering 129 countries, including all African countries. Despite significant progress, South Africa still experiences one of the highest numbers of new HIV cases globally. New prevention options will be critical to reaching people who remain at risk of acquiring HIV. Aspen’s licensing rights extend to both the public and private healthcare sectors.
A Potentially New Dosing Approach to HIV Prevention
Alimatravir is an investigational medicine currently being evaluated in Phase III clinical trials for HIV pre-exposure prophylaxis (“PrEP”). While the product remains under clinical investigation and has not yet been approved by regulatory authorities, results to date have been encouraging and we look forward to the Phase III read out results.
If approved, alimatravir is expected to become the first once-monthly oral HIV prevention option available, offering a different and new approach to dosing for PrEP .
A monthly oral tablet has the potential to simplify access and reduce barriers to uptake, particularly in regions where healthcare personnel and access may be constrained.
Supporting Africa’s HIV Response
Africa continues to bear a disproportionate share of the global HIV burden, making expanded access to effective prevention options a public health priority.
Long-acting HIV prevention technologies are increasingly being recognised as important tools in reducing new infections and supporting global efforts to significantly curtail HIV transmission over the coming decade.
The ongoing Phase III clinical programme includes sites across multiple countries, with South Africa playing an important role and hosting the largest component of the clinical study.
Expanding Access Through Local Manufacturing
The agreement is expected to support Aspen’s broader objective of advancing pharmaceutical manufacturing capabilities in Africa while contributing to sustainable healthcare security across the continent.
While HIV treatment products have historically been concentrated within public sector programmes, there is expected to be growing need for preventative healthcare solutions within the private sector, creating an opportunity to broaden access to patients who could benefit from PrEP.
Accelerating Future Access
Where requested by the African regulatory authorities, Aspen and MSD shall provide the necessary support to advance efficient regulatory pathways upon successful completion of the Phase III clinical programme.
Should Phase III outcomes be favourable, regulatory submissions are expected to follow, with the objective of making this HIV prevention option available as quickly as possible across licensed territories.
South African Minister of Health, Dr Aaron Motsoaledi welcomed the announcement on the licesing of alimatravir on the basis of its potential to make an impact on South Africa’s HIV prevention programme. Minister Motsoaledi stated, “This is a significant milestone in our collective efforts to end the HIF epidemic in South Africa and globally, especially after the government has recently launched another game-changer, Lenacapavir, in the fight against new HIV infections.”
“The country remains committed to expanding the HIV prevention toolkit, particularly options that are convenient, acceptable, and effective for diverse and vulnerable populations including most adolescents, young women, key populations, and communities with limited access to daily medication,” said Minister Motsoaledi.
The Minister added, “South Africa carries one of the highest HIV burdens in the world, and every new tool that removes a barrier to prevention matters. A once-a-month oral option, if brought to market through local manufacturing partnerships such as this one between MSD and Aspen, has the potential to improve adherence compared to daily dosing particularly among young women and adolescent girls, who remain disproportionately affected by new infections.”
Motsoaledi concluded that “Local manufacturing also strenghens our health security, ensuring that when a product like this is proven safe and effective, South Africans are not left waiting at the back of a global supply queue. We welcome this partnership and will continue working with all stakeholders to ensure that when this innovation is ready, it reaches our people quickly, affordably, and equitably.”
South African Miniter of Trade, Industry and Competition, Parks Tau said, “This partnership between Aspen and MSD demonstrates the value of strategic collaboration in advancing South Africa’s industrial capabilities while also addressing one of our most pressing public health challenges. By manufacturing this innovative HIV preventative medicine locally, we are strengthening our pharmaceutical industry, advancing localisation, creating high value capabilities and contributing to improved health outcomes across Africa.”
Director General of the Africa Centre for Disease Control, Dr Jean Kaseya said, “The partnership between Aspen and MSD is an important milestone for Africa’s pharmaceutical manufacturing ambitions. For decades, Africa has participated in clinical research while manufacturing and much of the economic value were created elsewhere. This agreement points to a different future”.
About Alimatravir (MK-8527)
Alimatravir is an investigational HIV prevention medicine currently in Phase III clinical development. The product has not been approved by any regulatory authority, and the profile (safety, efficacy, and adherence) has not yet been established for commercial use. Any future commercialisation remains subject to the successful completion of clinical trials and receipt of the necessary regulatory approvals.