- A Johannesburg-based company will begin manufacturing a flexible silicone ring to protect women from HIV.
- This move shows strong confidence in African companies to supply rings at the right scale and at an affordable price, and is an important step towards making the continent self-reliant.
- Kiara Health CEO Dr. Sukumbuzo Ngozwana said the price of the ring was not yet known, but it was expected to be lower than the current price of the Swedish-made Dapiring.
A South African company has secured the rights to manufacture a vaginal ring used to prevent HIV infection.
Rings that you insert and remove are protected for one month, after which they must be replaced with a new ring.
The ring contains an antiretroviral drug called dapivirine.
Studies have shown that the dapivirine vaginal ring is less effective at preventing HIV than HIV preventive drugs or injections, but it has advantages over other tools and the World Health Organization (WHO) recommends that women have access to sexual We recommend including dapivirine in health service packages. .
One of the ring's advantages over HIV prevention drugs is that it can be used discreetly by women, and users can use the ring without having to negotiate or discuss its use or purpose with sexual partners.
The dapivirine vaginal ring is the first long-acting HIV prevention method designed for women and is approved for use in women 18 years of age and older. (Photo provided to Spotlight)
This is particularly important in the South African context, where women face high rates of gender-based violence, which erodes their autonomy over their bodies and sexual and reproductive health.
“We want to give women more control over their health and their bodies, allowing them to choose what's best for them at different times in their lives by offering a wide range of safe and effective options, including Dapivirine Ring. ” wrote several prominent African women activists in 2022.
Limited access
The WHO recommends the ring be made available to women, but the current price is a barrier to widespread use and deployment in South Africa.
The only dapivirine vaginal ring currently available in the country and approved by the SA Health Products Regulatory Authority is called DapiRing.
DapiRing is manufactured by the Swedish company Sever Pharma Solutions under license from the Population Council (formerly known as the International Partnership for Microbicides).
It can be purchased in the private sector in South Africa for R320, excluding dispensing fees.
Read | Pilot project in South Africa now offering HIV shots
Dapiring is being sold in the public sector outside of research and pilot sites because the National Essential Medicines List Committee, the body that determines medical technologies available in public health facilities in South Africa, has determined that the product is currently unavailable. It is not available. price.
They estimate that the product will be affordable to the South African public sector at a base price of R52 per ring.
Local businesses expand access
The Population Council, the organization that owns the intellectual property for the dapivirine vaginal ring, has selected South African pharmaceutical company Chiara Health to manufacture and supply the ring across Africa.
Kiara Health CEO Dr. Skhumbuzo Ngozwana told Spotlight that the price of the Kiara ring is not yet known, but it is expected to be lower than the current price of the Swedish-made DapiRing.
manufacturing permit
The council told Spotlight that the initial focus of the license and partnership was to develop Chiara Health's manufacturing capacity to supply dapivirine vaginal rings across Africa.
In the long term, it is hoped that Chiara will be able to serve markets outside of Africa that require rings.
The Population Council's selection of an African-based manufacturing partner is noteworthy, as holders of intellectual property protection for HIV medical technologies have typically sought companies from Asia, particularly India, as manufacturing partners.
Read more | Ministry of Health is concerned that only 80% of people living with HIV are taking ARVs
Professor Linda Gail Becker, CEO of the Desmond Tutu HIV Foundation, told Spotlight: Southern Africa is one step closer to independence. ”
Kiara Health offers in-house pharmaceutical expertise including stability testing, quality assurance and post-import testing. (Photo provided to Spotlight)
Mr Ngozwana said the Population Council appreciated that Kiara Health Department had reversed this trend by not going east.
”[A]All of these new technologies tend to head east, but instead we partnered with African companies. ”
He added that future technology transfer to other African manufacturers could also be pursued if required.
exclusive supply license
The council told Spotlight it intends to pursue an exclusive supply license with Chiara Health for the sole supply of the dapivirine ring in Africa.
Obtaining the exclusive supply license is a sign of strong confidence by the Population Council in Kiara Health's ability to supply the ring at an appropriate scale and at an affordable price.
Kiara Health's exclusivity lies in the supply of the ring, so if required, the company can supply dapivirine vaginal rings manufactured by Sever Pharma Solutions, the Population Council's Swedish manufacturing partner. Used in African countries.
This would also prevent supply shortages that sometimes occur when only one manufacturer supplies the market, Dr. Brid Devlin, chief scientific officer at the Population Council, told Spotlight.
“We have two registered manufacturers available immediately to prevent any shortages, giving us the opportunity to continue supply as demand increases.”
Why Chiara Health was chosen
Mr Devlin added that the Population Council did not have a formal bidding process in which Chiara Health was selected as the manufacturing partner for the ring, but rather Chiara Health was selected after a long-standing association with the company.
“Our team went to Chiara last year to tour the site and it was a really impressive operation, both in terms of staff and the overall manufacturing operation,” she said.
Ms Ngozwana told Spotlight Kiara Health that they have an existing manufacturing facility in Johannesburg, where the capacity to produce the rings will be established.
Kiara Health's manufacturing facility already has the necessary quality assurance certifications to manufacture the drug, and there is sufficient space in Johannesburg to establish and expand manufacturing capacity for the ring, Ngozwana told Spotlight. Told.
What does it take to manufacture a ring locally?
Key steps include technology transfer, financing, sourcing and importing manufacturing equipment, developing validation batches, and obtaining regulatory approval.
At this time, it is still unclear the extent of data and testing required to obtain regulatory approval for Chiara Health's dapivirine vaginal ring.
Ngozwana and Devlin noted that Chiara Health will use the same manufacturing technology and inputs, including active pharmaceutical ingredients (APIs), used by Sarver Pharma Solutions to support regulatory approvals. .
This will require Chiara Health to import manufacturing equipment and drug substance from Europe.
Kiara Health manufactures its own medicines and offers customized manufacturing services. (Photo provided to Spotlight)
However, in the long term, Ngozwana said Chiara Health would like to increase its sourcing of manufacturing raw materials, including the possibility of dapivirine API from Pretoria-based API manufacturer CPT Pharma (Spotlight previously reported on CPT Pharma's API production efforts here).
Ngozwana and Devlin told Spotlight that the expected time-limiting factors in establishing manufacturing capacity are securing funding and sourcing and importing manufacturing equipment.
Also read | 'Alarming' resurgence of sexually transmitted diseases in Gauteng
Financing has long been a challenge for Africa-based pharmaceutical companies, as funding has historically been scarce and available only on unfavorable terms.
However, Mr Ngozwana told Spotlight Kiara Health that he has already approached potential funders for support and is exploring various sources of funding, including grants and debt instruments.
Ngozwana and Devlin pointed out that technology transfer, the process of transferring manufacturing skills and knowledge, has already begun.
Will this license further increase domestic manufacturing capacity?
Vaginal rings are a relatively new type of health technology, but they have multiple potential uses.
Vaginal rings to prevent pregnancy have been available since the early 2000s, and work is underway to develop rings that are effective in combating both HIV and pregnancy.
A dapivirine ring is also being developed that reduces the risk of HIV infection by three months instead of one.
“There are some great multipurpose prevention technologies based on vaginal rings in the development pipeline. [the Kiara Health licence] “It has potential implications for more than the dapivirine ring,” Becker told Spotlight.
Chiara Health is positioning itself to manufacture other vaginal rings that enter the market, Ngozwana said.
He added that in the long term the company wants to expand its partnership with the Population Council to enable local manufacturing of other sexual and reproductive health technologies in its product portfolio.
*This article Published by Spotlight – Health Journalism in the Public Interest. Sign up for the Spotlight newsletter.
