Stephen Saad, Aspen Group CEO. .
Image: Supplied
Aspen Pharmacare Holdings has reached a licensing agreement for a medicine still under formal approval process, that may provide a once-monthly, long-acting oral medicine to prevent HIV-1.
Aspen said Friday the agreement was with MSD, a subsidiary of US-based Merck & Co, and it provides Aspen with rights to develop, manufacture, and commercialise MK-8527, or alimatravir, an investigational, late-stage, once-monthly, long-acting oral medicine for the prevention of HIV-1.
“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,” South African Minister of Health, Dr Aaron Motsoaledi, said in a statement.
Aspen Group CEO Stephen Saad said the agreement is an important step in their commitment to improve access to new medicines in Africa and strengthen local pharmaceutical manufacturing capabilities.
“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,” said Saad.
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. Aspen's licensing rights extend to both the public and private healthcare sectors.
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 the group looks forward to the Phase III results,” said Saad.
“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," he said.
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.
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 many countries, with South Africa hosting the largest component of the clinical study.
While HIV treatment products have historically been concentrated within public sector programmes, there is expected to be a growing need for preventative healthcare solutions in the private sector, creating an opportunity to broaden access to patients who could benefit from PrEP.
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, said Saad.
“This is a significant milestone in our collective efforts to end the HIV epidemic in South Africa and globally, especially after the government has recently launched another game-changer, Lenacapavir, in the fight against new HIV infections,” said Motsoaledi. Lenacapavir is a long-acting antiretroviral medicine used to both treat and prevent HIV-1 infection.
“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 Motsoaledi.
“Local manufacturing also strengthens 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,” the minister added.
Trade, Industry and Competition Minister Parks Tau said, “This partnership demonstrates the value of strategic collaboration in advancing South Africa’s industrial capabilities while also addressing one of our most pressing public health challenges.”
Africa Centre for Disease Control Director General Dr Jean Kaseya said, “For decades Africa has participated in clinical research while manufacturing, and much of the economic value was created elsewhere. This agreement points to a different future.”
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