Aspen secures game-changing HIV medicine

Aspen Pharmacare’s recent licensing agreement with MSD will grant Aspen rights to develop, manufacture and commercialise MK-8527, or alimatravir, in a huge stride forward in HIV prevention for the continent.

Alimatravir is a late-stage investigational, once-monthly, long-acting oral medicine for the prevention of HIV-1. MSD is a Merck & Co subsidiary which has been at the forefront of research into the prevention of diseases including HIV, cancer and Ebola.

Stavros Nicolaou, Aspen Pharmacare Group’s senior executive responsible for strategic trade development, told Sunday Times that Africa harbours around 70% of the world’s HIV-infected population and South Africa has the highest HIV prevalence rate in the world, with about 16% of the world’s HIV-infected population.

“HIV/Aids and associated diseases such as TB have been a significant drain on public health resources and economies on the African continent. Although significant strides have been made in recent times in turning the tide against HIV on the continent, some complacency and donor aid cutbacks are unfortunately starting to disrupt HIV programmes with a risk of some backslide.”

Nicolaou said South Africa and Africa cannot afford to slide back to the gloomy early days. In the early 2000s, around 300,000 South Africans a year were dying from Aids-related illnesses.

“The introduction of long-acting, preventative HIV medicines, both in injectable and in oral forms, presents a real opportunity to potentially eliminate HIV/Aids in South Africa in the next decade.”

He said this will require that South Africa reaches its 95-95-95 target and places 95% of its 9-million HIV-infected population on antiretroviral therapy (ART), meaning this part of the population will be virally suppressed, significantly suppressing infection from the infected to the uninfected population.

“It will also require the effective roll-out of the long-acting preventative HIV medicines at scale. Aspen pioneered the first generic ARVs on the African continent, which has gone on to play a significant role in reversing both HIV mortality and morbidity, and its agreement with Merck MSD for the investigational ARV preventative medicine alimatravir is potentially game-changing.”

Alimatravir is in late-stage clinical trials and presents, once registered and approved, another arrow in the quiver of South Africa to significantly increase prevention of HIV.

“Successfully suppressing viral loads of the infected population and the prevention of HIV at scale through compounds such as lenacapavir and, when registered, alimatravir presents a great opportunity for our country to eliminate the scourge of HIV in the next decade,” Nicolaou said.

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.

—  Dr Aaron Motsoaledi, minister of health

Alimatravir, if registered, will present an easy-to-use, simple preventative option, meaning one tablet, once a month, one hour to work and a one-week forgiveness on missed doses.

“Merck MSD needs to be applauded for concluding these licences at an investigational drug stage, as this means that the product can be registered and produced earlier in Africa, thereby accelerating access to patients and healthcare systems.

“Aspen producing this product in Africa satisfies both Africa’s access requirements and the important and operating expenditure priority of Africa to strengthen its own local manufacturing capacities, and ensures it controls its own supply security and health sovereignty.”

Aspen CEO Stephen Saad said the agreement marks an important step in Aspen’s commitment to improving access to new medicines in Africa and strengthening local pharmaceutical manufacturing capabilities.

“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.”

Minister of health Dr Aaron Motsoaledi welcomed the announcement on the licensing of alimatravir based on its potential to transform South Africa’s HIV prevention programme.

“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,” Motsoaledi said.

“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.”

He said for South Africa 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.”

Minister of trade, industry and competition Parks Tau said the 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.”

Africa Centres for Disease Control director-general 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.”