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Novo Nordisk and Aspen Pharmacare set to produce insulin in SA

Aspen says it is trying to improve access to a quality product. Photo: File

Aspen says it is trying to improve access to a quality product. Photo: File

Published Sep 21, 2023


The Department of Trade, Industry, and Competition (Dtic) said yesterday that the South African government welcomed the announcement by the global pharmaceutical company, Novo Nordisk, that it would produce insulin in South Africa through Aspen.

This comes after on Tuesday, the companies announced that Aspen Pharmacare had been contracted by the global manufacturer of human insulin, Novo Nordisk, to produce 16 million vials of insulin next year.

Novo said the amount that Aspen would produce next year under the contract equates to the yearly consumption of 1.1 million people with type 1 and type 2 diabetes.

In terms of the contract, Aspen Pharmacare Holdings Limited and its wholly-owned South African subsidiary, Aspen SA Operations had agreed with Novo Nordisk, to the technical transfer and commercial manufacture of human insulin.

Minister of Trade, Industry, and Competition Ebrahim Patel said: “We are optimistic that this partnership will significantly enhance access to insulin treatment not just in South Africa, but also across the continent.”

The contract will enable the local production of human insulin in South Africa through the conversion of insulin into finished dose vials. The collaboration will aim to supply over 1 million patients – 16 million doses in 2024 with a further upscaling to 4 million patients in 2026.

“As populations expand, and lifestyles and diets change, we face a rising tide of non-communicable diseases. These diseases are chronic in nature and place a significant burden on communities and families, as well as on health systems, the fiscus, and economies,” Patel said.

He said this was an excellent first step that he hoped would pave the way for both licensing and additional manufacturing opportunities, in areas such as sterile cartridge production and the production of high-demand and new classes of drugs, such as the glucagon-like peptide-1 (GLP-1), which is largely inaccessible at present to African patients.

The production of insulin would use Aspen’s sterile infrastructure in the city of Gqeberha in South Africa, including some of the infrastructure that was used for Covid-19 vaccine manufacture, the department said.

Aspen will deploy 250 people for this production, which would start in early 2024 and would reduce the transport-related carbon footprint by 68%.

“Africa’s population of 1.4 billion people is a vast market and provides the commercial rationale for production in Africa for Africa and the world. Production on the African continent will reduce the growing pharmaceutical trade deficit that both SA and the continent experience – Africa imports 99% of its vaccines and around 80% of its pharmaceutical requirements,” the Dtic said.

Meanwhile, Aspen Pharmacare Group Senior Executive responsible for Strategic Trade Development Stavros Nicolaou said some of the deals that Aspen had done recently were for trying to improve access to a quality product because they are targeted, and even if they are, they need to be tailored to a particular patient's needs.

“It is inherently going to be costly and inaccessible, that's the one aspect the second aspect is diabetes is probably the most sinister disease of all at the moment because we have high obesity rates in our country, and that is a trigger for diabetes so more and more younger people are getting diabetes these days.

“Diabetes is a trigger to a complex of diseases such as heart attack, cardiovascular disease, vessel disease, heart attack, hypertension, high blood pressure, which leads to strokes, etc. Diabetes is not just diabetes on its own, it's a very important trigger to several other very difficult-to-manage and costly diseases.”

He said insulin was very important, and when patients received this treatment, that would lead to less burden on the health care system, and in the medium to long term, improve the productivity of the labour force in the country.

Nicolaou said regarding the vaccine issue, the local and regional manufacturing of vaccines on the continent was going along, but probably not as quickly as the continent and the manufacturers would like it to go, and the reason for that is twofold.

“Number one is to produce a vaccine in Africa, and to sell it in Africa to commercialise it requires what we call a World Health Organisation (WHO) pre-qualification. The pre-qualification process is highly onerous and bureaucratic and is not conducive to assisting manufacturers in establishing capacity and capability on the continent.“

Despite this, he said it was a requirement and should never be compromised because quality, safety, and efficacy were important.

“However, there is a more expedient and less onerous process that could be pursued without compromising the quality of the product. It's going to require a look further by the regulators put differently by WHO pre-qualification to be aligned with realities and practicality on the ground.

“That's what the WHO must look at very closely because unless they reform, we're are always going to be on the back foot as Africa and then you are never going to produce your own vaccines and your own medicine,” he said.