đź”’ Good Samaritans stepping forward – SA pharma donates chloroquine tablets for Covid-19 treatment

The coronavirus epidemic is exposing the greedy and highlighting the good in many societies. In countries where the virus is raging, people are stepping forward to volunteer. In the United Kingdom, where the outbreak shows no sign of abating; a call for 250,000 volunteers to help the country’s National Health Service led to more than 600,000 signing up. In South Africa, two billionaire families, the Ruperts and the Oppenheimers were the first to put their hands up to donate R1bn each, putting to shame other well-known British billionaires like Richard Branson, who was asking for government help for his ailing airline. And now a South African pharmaceutical company has announced that they would be donating 500,000 chloroquine phosphate tablets to the Department of Health. Contrast that to US chloroquine drugmaker, Rising Pharmaceuticals who have doubled the price of the malarial drug. Chloroquine has been used successfully in some trials to reduce the time patients spend in hospitals. The chief executive of Austell pharmaceuticals, Suhail Gani spoke to Alec Hogg on how the South African Health Product Regulatory Authority managed to approve the drug within 5 days. – Linda van Tilburg

There’s been a lot of talk about chloroquine phosphate being the one drug that has already been identified to fight against Covid-19. The local company in South Africa – Austell Pharmaceuticals, the largest black owned pharmaceutical company – presumably has the license for chloroquine phosphate because they’ve just made a donation to the South African government of 500,000 tablets. Chief executive Suhail Gani joins us now. Let’s just dwell a little bit on this. This product chloroquine phosphate has been around for a long time and previously used to fight malaria.

That’s right. This drug has been around for over 70 years to fight malaria and the evidence shows that patients spend less time in hospitals and the amount of time a patient remains infectious is far less when the patient does contract Covid-19. I must just add something to that. More than 80% of the population doesn’t need this drug. This drug is used for patients who have underlying conditions like heart or lung conditions, or if they are severely impaired with this disease.

So where has it been used successfully against Covid-19?

If you look at the clinical guidelines for the management of Covid-19, it has been quite successfully used in China, South Korea as well as Belgium. It’s also in treatment protocols in countries like France, Australia and even the USA.

But presumably only used under very strict conditions? I think the whole world heard the story of somebody in America who took something related to chloroquine phosphate and died as did his wife.

I cannot comment because I haven’t heard the story but you are right. This will only be given by physicians and doctors and will only be given at hospital, this will only be available to the state and the decision whether to use it or not will only be made by health care professionals.

That sounds like it could be dangerous – like most drugs – if you take too much of it when you don’t need it.

I agree with you. That’s why we say go to your doctor. They always look at the risk benefit and they take a decision whether to give it or not.

You say it’s been around for 70 years. It seems a welcome thing that it’s working against Covid-19, who’s sought to use it in the first place?

I think it started first in China, because as we know the epidemic started there and they must have been experimenting with a number of drugs, chloroquine phosphate I think gave them the best results. And as you are aware, this was the epicentre of the epidemic and these restrictions are being lifted. So they have been quite successful in dealing with this pandemic.

How much chloroquine are they using in Wuhan?

If you look at the treatment guidelines it’s simple that initially the health care professional gives 10 milligrams per kilo depending on your weight for the first 2 days and thereafter 5 milligrams per kilo daily.

And so that is helping people recover more quickly from Covid-19.

Patients spend less time in hospital – and this is very important for everyone to understand – we have a finite number of hospital beds about 7,500 critical beds in the country. You want the patients to go out as soon as possible otherwise imagine if this – God forbid – pandemic hits a majority of our population. So what you need is a drug that can reduce the time patients stay in hospital. Otherwise that can be quite a crisis in South Africa.

By how much time does it reduce their hospital stay?

It reduces the time by up to 6 days, so you can spend less than 6 days in the hospital. But obviously it varies between patients.

So in other words, how long would you spend in hospital without chloroquine?

There’s no evidence to state how long one has it. It depends on your underlying condition. You can spend weeks – 3 to 4 weeks – but what we know is that it does reduce the time.

So these 500,000 tablets that you’ve now given to the South African government. How many patients will they help?

I think it will help – depending on the dose – up to 20,000 patients. We have however decided to donate another 500,000 tablets. That will be announced in the press soon. We have donated in total a million tablets and it will treat up to 40,000 patients. But I hope it doesn’t come to that.

So presumably, you can’t just go to the government and give them a whole bunch of pills. You’ve got to go through some kind of a formal process. How does that work in South Africa?

What actually happened is – because as you said, the drug is not used for this indication, when we heard one of the things that the president said and how does the private and public sector work together to beat this epidemic, we approached the Department of Health and said this is what we can bring. But the most important catalyst for this is we saw it published in the South African guideline for the clinical management of Covid-19 on the 19th of March. We went to see them on the 20th and said we’re willing to help the government by donating the product. So we went through the protocol with the Department of Health and thereafter with the regulatory body – as you know it’s called SAHPRA – the South African Health Product Regulatory Authority and I have to tell you there have been quite positive engagements and they expeditiously approved the drug within 5 days.

Five days. That’s incredible. But I guess it shows that it is a crisis. Do you guys actually make the drug here?

We don’t make the drug here because South Africa doesn’t have malaria indications. It comes from one of our partner companies in India.

And they presumably aren’t charging you?

They are charging us…

and you’re giving it to the country for free. That’s good news.

One of the things is that there’s such a demand for this product that there is a critical shortage of this drug in the world. In fact India has banned the export of this product anywhere in the world. However we got a commitment from the Indian government and we will have the stock within the next 3 weeks. I’m a South African at heart. I was born here. My parents were born here and we said we have to do something to secure the supply and I’m glad to say we have.

This is so interesting. So it’s the relationship between the Indian government and South Africa that, in this case, enabled you to bring in drugs to the country that India has banned from exporting elsewhere because they’ve got their own issues.

That’s right. And because of our partner – that we have had for the last 20 years – there is an understanding to ensure that we do something for our country.

Suhail Gani is the chief executive of Austell Pharmaceuticals and as he’s just told us that a million of those chloroquine phosphate tablets will be coming to the South African Department of Health. Free of charge. I guess the cost is not the big thing, it’s the access that is probably more important given the demand now for this drug.

Covid-19: SAHPRA approves the use of Chloroquine Phosphate in South Africa

Austell Pharmaceuticals media statement

26 March 2020 – The South African Health Products Regulatory Authority (SAHPRA) has given approval for Austell Pharmaceuticals to donate 500,000 Chloroquine Phosphate tablets for use by the Department of Health (DOH).

Austell Pharmaceuticals will donate these Chloroquine Phosphate tablets to the government, free of charge, as part of our contribution to the fight against Covid-19.

Austell would like to thank the DOH and SAHPRA for the expeditious review and approval of Chloroquine Phosphate in terms of Section 21 of the Medicines and Related Substances Act.

Austell’s donation of half a million tablets follows a growing body of evidence that Chloroquine Phosphate can reduce the number of days Covid-19 patients spend in hospital, and the amount of time patients remain infectious.

On the 19 March 2020, South Africa adopted Chloroquine Phosphate in its guidelines for the clinical management of Covid-19, published by the Department of Health and the National Institute for Communicable Diseases.

China, Belgium and South Korea have also adopted Chloroquine Phosphate in their COVID-19 treatment guidelines, while the drug has been recommended for use in France, Australia and the USA.

We fully support President Ramaphosa’s announcement of a national lockdown. This should dramatically decrease the rate at which the Covid-19 virus is spreading throughout the country, and alleviate the pressure on our healthcare system.

We believe that, by reducing the time that patients remain in hospital, Chloroquine Phosphate can help to further reduce the pressure on the healthcare system. This will allow more people to access the healthcare services they need.

Austell Pharmaceuticals, South Africa’s largest black-owned pharmaceutical company, is committed to its credo “medicine with a conscience.” This donation of Chloroquine Phosphate is an expression of that commitment and our solidarity with the South African government.

Together, we can beat Covid-19.