Tag: Aspen

Injections against HIV could be Manufactured Locally and Cheaply, Says Aspen Pharmacare

Female scientist in laboratory
Photo by Gustavo Fring on Pexels

In 2020, pharmaceutical company ViiV Healthcare announced that a bimonthly injection of its new drug, cabotegravir, prevents HIV infection. More than two years later, the drug is still unaffordable in countries where HIV is highly prevalent.

Local medicines manufacturer Aspen Pharmacare says that licences should be given to African producers so that cabotegravir can be made more affordable and accessible.

Cabotegravir can be used to prevent HIV infection. This is known as Pre-Exposure Prophylaxis, or PreP. Currently, PrEP is only available in pill form and has to be taken daily. A bimonthly injection is an appealing alternative that, if made widely available, can make a big dent in the HIV infection rate. 

Globally, 1.5-million people are infected with HIV and about 650,000 people die of AIDS every year. UNAIDS’s target of reducing annual infections to fewer than 500,000 by 2020 was not reached. It is widely accepted among experts that prevention as well as treatment is necessary to end the epidemic.

Although the World Health Organisation has recommended cabotegravir for PrEP, it is unaffordable, especially in developing countries where HIV is most prevalent. The Clinton Health Access Initiative (CHAI) has estimated that cabotegravir could be manufactured for just over $65 (R1100) a year.

According to The Guardian, ViiV’s not-for-profit price for cabotegravir is estimated to be $240-$270 (R4,059-R4,567) for a full year’s supply for one patient.

But in the United States, a full year’s supply for one person of cabotegravir is sold for more than $22,000 (R370,000). In the UK a year’s supply is $9,275.

In comparison, oral PrEP costs about R686 for a full year’s supply for one patient in South Africa. Cabotegravir is not yet approved by the South African Health Products Regulatory Authority.

Stavros Nicolaou, group senior executive strategic trade at Aspen Pharmacare, says that there is local capability to manufacture cabotegravir but licences have not yet been granted. The company invested heavily in sterile equipment, needed to produce injections, during the Covid-19 pandemic. This can be used to produce cabotegravir.

Aspen is the biggest producer of antiretrovirals (ARVs) in Africa. Nicolaou says that giving licences to African producers is crucial to ensuring the equitable supply of medication.

ViiV has committed to allowing generic versions of the drug to be manufactured but has said that the process is complicated. Cabotegravir is currently only manufactured at one site in the UK.

In July, activists interrupted presentations during the AIDS 2022 conference in Montreal, calling on ViiV to lower the price of cabotegravir. Doctors Without Borders (Médecins Sans Frontières) has urged ViiV to make the drug available in high-prevalence countries and to be more transparent about its pricing and manufacturing process.

ViiV has come to an agreement with the Medicines Patent Pool (MPP), a nonprofit organisation that will facilitate the process of awarding licences to manufacturers.

But Dr Andrew Hill from the Department of Pharmacology at the University of Liverpool says that the agreement is highly restrictive.

Hill says that many countries have been excluded from the list, particularly those in South America and Asia, including those with high HIV infection rates.

He says that most of the world’s population could be reached if cabotegravir was made available at the CHAI price of $65 (R1100) per patient per year. That it is not yet widely available is a “failure of public health”, he told GroundUp.

In South Africa, where just under 14% of the population has HIV, the announcement of cabotegravir two years ago was widely celebrated among clinicians.

The researchers we spoke to suggest that the uptake of cabotegravir would be higher than that of PreP tablets and so it would be more effective. Most new infections in Sub-Saharan Africa are among women and adolescent girls. Cabotegravir offers them a discreet alternative and one that doesn’t require daily adherence.

“It’s very frustrating,” says Juliet Houghton, CEO of the Southern African HIV Clinicians Society. Houghton says that if cabotegravir can be rolled out in pharmacies across the country, with pharmacists allowed to administer it, it will greatly increase the uptake of PrEP and reduce infections.

“We can’t just keep treating people for HIV,” Houghton says. “Prevention has to be the way forward.”

“We need to look at PreP closer to the way we look at contraception,” says Andy Gray, senior lecturer in Pharmacology at the University of KwaZulu-Natal. Offering more choices that fit into a variety of lifestyles is likely to improve the uptake of PrEP, he says.

Dr Yogan Pillay, country director for CHAI, says that governments and civil organisations need to pressure ViiV and MPP to increase the availability of cabotegravir.

“That 82% of the 250 000 adolescent girls and women that acquired HIV in 2021 are in Sub-Saharan Africa makes it imperative that cabotegravir is made available at an affordable price as soon as possible,” Pillay says.

“We need this drug, we need it now, and we need truckloads,” says Professor Francois Venter, executive director of Ezintsha at Wits. “It works very well. It is safe. And while we still have to figure out how to use it best, we can’t do that with nothing in hand.”

A spokesperson for ViiV Healthcare told GroundUp: “We believe cabotegravir long-acting (LA) for PrEP has the potential to change the shape of the HIV epidemic and we are ambitious for the impact we can have together with global health partners to bring this medicine to those who need it.”

ViiV says that at first, three generic manufacturers will be selected by MPP.

“Enabling up to three generics in the first instance allows for competition but avoids a fractured market with too many manufacturers and a risk of there not being enough demand to sustain the long-term manufacturing commitments to be made by licensees,” ViiV said.

ViiV also said they are working with various partners to ensure that Cabotogrevir is accessible to countries in Sub-Sarahan Africa.

“We know that affordability is a real challenge in these countries, and we are working with our partners to look at affordable pricing, demand and innovative funding mechanisms to help enable access for people who could benefit from PrEP,” ViiV said.

ViiV says that CHAI’s price estimation is unrealistic because of the complexity of the manufacturing process.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Closure Threat for SA’s COVID Vaccine Plant as Orders Dry up

Female scientist in laboratory
Photo by Gustavo Fring on Pexels

South Africa’s COVID vaccine production plant, the first of its kind in Africa is at risk of closure after failing to secure a single according to a report from Reuters. President Cyril Ramaphosa is reported to be in talks with three other African nations in effort to save the venture.

The World Health Organization had called the licensing deal between Johnson & Johnson and Aspen Pharmacare to manufacture the Aspenovax COVID vaccine, a “transformative moment” in the pursuit of equitable access to vaccines. The vaccine is the J&J adenovirus vector vaccine sold under the Aspen brand.

However, after initial vaccine delivery shortfalls, the African continent is now well stocked with vaccines, while the poor infrastructure hampers vaccine distribution.

“There’ve been no orders received for Aspenovax,” Reuters reported, citing a phone conversation with Aspen senior director Stavros Nicolaou.

“If we don’t get orders, we would have to repurpose these lines back into other things that we were previously doing,” he told CapeTalk.

There are several other such vaccine plants in various stages, as the African Union aims at 60% of locally produced vaccines for continent locally by 2040, up from the current 1%.

“If Aspen doesn’t get production, what chance is there for any of the other initiatives?” Nicolaou remarked.

Regarding possible options, he said: “We are exploring various options. It is our medium-to-long-term objective to look at providing a sterile [processing] platform and solutions for the continent but the short-term needs to be sorted out.”

Moderna announced an agreement with Kenya to set up its first mRNA manufacturing facility in Africa with the aim of producing up to 500 million doses a year.

Source: Seeking Alpha

Aspen to Locally Produce COVID Vaccine ‘Aspenovax’ for the African Continent

Syringe withdrawing from vaccine vial
Photo by Mufid Majnun

In a news release, pharma giant Aspen has announced that it has concluded an agreement with Johnson & Johnson to manufacture an Aspen-branded COVID vaccine, Aspenovax, and to make it available throughout Africa.

This follows on from the November 2021 announcement of an agreement of terms between the two companies. This new agreement will expand the existing technical transfer and manufacturing agreements between the companies.

The agreement will grant Aspen’s South African subsidiary the rights to manufacture finished Aspenovax product from drug substance supplied by J&J. It will also make Aspenovax available to markets in Africa through transactions with designated multilateral organisations and with national governments of member states of the African Union.

Under the agreement, Aspen has secured the necessary intellectual property from Johnson & Johnson for production. There is also a good faith undertaking between the companies to expand the agreement to cover any new versions of the drug substance, such as those developed for new variants or a different formulation for administration as a booster.

The agreement will last through to the end of 2026.

Commenting on this agreement, Dr Matshidiso Moeti, World Health Organization Regional Director for Africa said: “This important agreement on sharing know-how and technologies for the production of COVID vaccines is a huge leap forward towards realising our shared vision for medicines and vaccines to be manufactured on the African soil for the African people. Vaccines are our best way out of this pandemic and local production is an essential recipe for our success.”

Stephen Saad, Aspen Group Chief Executive said: “Even with all the support in the world, none of this would be possible without the competence of our teams at Gqeberha. They knew the weight of a continent’s ambitions rested on their shoulders. They persevered and succeeded in becoming a significant supplier within the Johnson & Johnson network. Aspenovax has become a reality due to the confidence placed in their abilities. They are our African heroes.”