🔒 The inside story from Aspen on Covid-19 dexamethasone: MUST LISTEN

This week, the world woke up to the exciting news that dexamethasone, a cheap drug in the Aspen stable, dramatically improves the chances of survival for people seriously ill in hospitals with Covid-19. The Aspen share price has jumped up in value on the Johannesburg Stock Exchange as investors anticipate high demand for dexamethasone. In this interview with BizNews founder Alec Hogg, Aspen group senior executive Stavros Nicolaou shares the details of what is known about Dexamethasone and how it will be made available. – Editor

There was lots of action on the Johannesburg Stock Exchange today for Aspen, the pharmaceutical company that dominates the South African sector. And that’s because of a drug called dexamethasone. Stavros Nicolaou is the senior executive of strategic trade for Aspen. 

Aspen owns the global rights for this product and means we own the rights in multiple geographies, including the rights for South Africa. In South Africa, we have the injectable form and that is manufactured for us by a third party contract manufacturer, who happens to be located in Port Elizabeth. We own the rights to the product and the intellectual property in South Africa and it gets manufactured by a third party manufacturer on our behalf. 

Can you export it? 

We can. The products available under the Aspen brand in multiple markets. There’s an oral form and there’s an injectable form. The oral form we manufacture in our German facility in Bad Oldesloe. We export it from our German facility to a number of other markets. We have the injectable form available in other markets, such as Asia, for example, and in those markets, it’s also third party manufactured for us. 

It is a big deal for you.

We were probably informed of this when everybody else was because there was this ongoing study. We had a sense of it, the so-called Oxford study, the preliminary results were released on Sunday evening. We will continue to monitor the preliminary results and also the results that come out thereafter. It is certainly showing a lot of promise because we are seven months into this pandemic if you assume it started in December or thereabouts in China and there hasn’t really been any therapy thus far that is reducing the mortality rates by 30%, as suggested in the Oxford study. A 30% reduction in the mortality rate for severely ill Covid patients is certainly a significant development, medically speaking. 

Let’s start at the beginning. Dexamethasone, what exactly is it? 

The simple answer is it’s a corticosteroid otherwise often known as cortisone. Cortisone-based products are used for the management and treatment of various inflammatory conditions. There is a multitude of inflammatory conditions, everything from asthma to things like dermatitis, which is skin inflammation. It has widespread usage, and it’s probably not surprising that it’s demonstrating this effect in Covid because there’s been for many weeks now, a suggestion that the virus triggers an intense immune response. That immune response can potentially disrupt the body’s clotting mechanism, that’s why you’re starting to see a manifestation of micro clots. Very often it’s micro clots, it’s postulated that are causing the death of these patients. This being an anti-inflammatory would suppress, at the right time, that intense immunological response. It’s probably not surprising it is, however, potentially a new indication for this corticosteroid dexamethasone. 

Before anybody can make the kind of statements that we’ve seen from the Oxford trial, they have to have a trial. How exactly do they go about that, and in this case, how many people were involved? 

My understanding is that the trial included 4500 patients. Of course, these trials follow certain clinical protocols. They’re done on a double-blind basis, meaning that you don’t really know who’s taken the product and who hasn’t. That’s to ensure, in business terms it’s a medical governance if I have to equate it, so that you’re not fund cheating, so to speak. You do these double-blind randomised studies, this study was conducted along those lines. In certainly the preliminary results, as I said, you have indicated this 30% reduction in mortality, which is meaningful. 

The UK media has gone nuts about it – BBC, Telegraph, The Times. Wherever you want to have a look there they are calling it the wonder drug. Is it? 

I think it depends on your view of a 30% reduction. What I’d like to say is it’s better than anything else has demonstrated thus far. There have been other products like Remdesivir for example, the suggestions also on a preliminary basis reduce hospital stays by 4 days. That’s not as impactful as if you’re getting a 30% mortality reduction. At the end of the day, what scares the living daylights out of people with Covid is two things, that it’s highly contagious and secondly is that the mortality rates in relative terms are quite high. So if you’re reducing those by 30%, I think it is significant and meaningful. We’ll continue to monitor what comes out of this study. 

Stavros, just help us through here. So it affects or helps people who are on respirators. Why would that be? Why can’t you take it before you get sick or when you’re just a little sick? 

I think the first thing is patients that are severely ill with Covid eventually develop what’s called ARS, that’s an Acute Respiratory Syndrome. They become distressed, their breathing is distressed. Those patients often have to go either on to what’s called an invasive ventilator or a non-invasive form of a ventilator. I think there is a linkage there and part of the linkage is that these patients that are going into respiratory distress are starting to develop clotting problems or coagulation problems. 

When you say respiratory distress, they’re battling to breathe and as they’re battling to breathe the virus is giving them clotting problems and dexamethasone, your drug can actually clear that up for 30% of people who would otherwise have died? 

That’s largely the hypothesis. Yes. 

How much of the world would you be supplying this drug into? Presumably, now that we know that it does help or the Oxford study suggests a significant impact, there’s going to be a big demand. 

We haven’t really come to terms with what the demand and supply curve is going to look like. We were probably as surprised as many other people. It’s not like we’ve had notice of this for many weeks and try to develop what the supply patterns might look like. It is fairly early. It does have a rather targeted indication. As I said, it’s used for and you correctly said for those patients that are severely ill and are either on ventilation or assisted oxygenation. We were approached rather proactively by the minister of health this morning and also the minister of trade and industry of South Africa. They are taking quite a proactive stance on this. As a country, we haven’t developed what the requirements are yet. It’s a work in progress and we’ll have ongoing discussions with the health department in South Africa in the next few days. In fact, I’ve just come off a call with the director-general on this issue, still very much a work in progress. 

Who invented this drug?

To be frank, I can’t answer that because this drug was invented long before you and I were born. This drug is about 7 or 8 decades old. Cortisone as a drug was used in the early 1900’s. 

How did you get it in your portfolio? 

We acquired it around 9 or 10 years ago. It was part of an acquisition of a basket of similar type of products. These products, interestingly, are called high containment products. So cortisone is manufactured in what we call a high containment facility. The reason it’s got to be made in a highly contained facility is these drugs can be toxic in the production phase. You’ve got to have them in highly contained areas, you can’t have them in general manufacturing facilities. They’re not drugs that are readily manufactured, they’re quite a niche manufacturing capability. This formed part of a basket with other products like Eltroxin which is used for thyroid disorders and also needs a high containment capability. So they were niche products, they didn’t have massive volumes at the time. Aspen is a lot about getting into these niche products strategically speaking and how we position our business globally. 

So who else in the world produces dexamethasone? 

There are a number of generics, but you don’t get the same number of generics as you would for an analgesic or a basic antibiotic. So there are generic products, but they are far and few between in relative terms to the rest of the generic market. We’re certainly not to any producer or owner dexamethasone, there are other suppliers. 

Are you the biggest supplier? 

Again, I’m going to pass on that because I’m not sure. We must be one of the bigger players but I can’t tell you if we’re the biggest. I don’t think we’ve got that analysis. 

The important thing is that you do have the rights to produce this drug in your factories around the world. As the demand increases, presumably, you would then be upscaling your capability to manufacture it. 

We would certainly consider that. Particularly, as I mentioned earlier, we make the tablet form the oral solid form in our facility in Bad Oldesloe in Germany. We’ve got direct control of that capability. Then we work with various third-party partners with respect to the injectable form that can also potentially be expanded if we work together with these third parties. 

I’m still trying to get my head around this. You’ve explained that it is a difficult product to produce because of the toxicity during the production phase. Maybe we could look at it differently, when Remdesivir was shown to assist in Covid-19, do you have any idea what happened to demand for that drug? 

The demand hasn’t grown exponentially for the drag. I can tell you that much, I know that the innovator of Remdesivir has reached out to other licences and granted licences to other manufacturers to make the product globally. There certainly hasn’t been a global explosion of the product, and that multifactorial. I think it’s a new product, people are still assessing it and weighing it up. Certainly in South Africa, there hasn’t been an explosive need for it. I think these things, some of them get weighed up by clinicians, and clinicians largely are going to drive the demand for this product because they are the ones that need to position it in the therapy protocols. What I can say with the Aspen product, we have got the injectable form in South Africa. We’ve got some stocks available and we’ve got the ability to increase the capacity, either through partners or in the case of tablets, we could look at this something called a Section 21 dispensation. Which means you can bring an unregistered product into the country under the control of SAHPRA, which is the Drug Regulatory Agency of South Africa. We’ve got those options and we have got the capability to certainly increase capacity for this product, either directly or indirectly. 

Outside of the corporate impact on Aspen, from a national impact, it does mean that South Africa will have plentiful supplies of dexamethasone, whereas some of the other drugs are very difficult for us to get our hands-on. 

Stephen Saad went on record this morning, we’ve had an approach from our government, as I indicated earlier, said that we will certainly do our level best to make sure that we meet South Africa’s demands. It’s a good news story for our country. At these difficult times, particularly now that we’re going into this next 60 day period because we always said this pandemic is going to start peaking in the third week of July. It looks like we are on track for that. This is when you start seeing overflowing ICU’s and deaths, unfortunately, that’s roughly about a 60 day period. You go to whether the winter storm. I think it’s nice to have that acknowledgement that there’s a South African company, we made BBC and CNN and it’s a nice story during bleak times that a South African company got this product that’s being globally acknowledged. It’s an old product and it’s off the back of a study that we only ourselves found out about 48 hours ago. 

BBC and CNN, why did they speak to you and not to others who manufacture the product around the world?

I’m actually not sure. Our product is fairly well-branded across a number of the developed markets. We don’t necessarily sell it under the same brand name university speaking. So I think it’s a fairly well-branded product and I would assume they picked up on that.