Why Unitaid keep turning up for Ivermectin
Their repeated appearance is patently absurd
Either Unitaid just got lucky and turned up at four critical moments in the regulatory process of Ivermectin, or Unitaid has some intelligent rationale behind their actions.
What might such a rationale be?
In the extensive register of interests document for NICE’s decision against Ivermectin, Andrew Owen declares he is the co-inventor of multiple patents relating to drug delivery mechanisms ‘including for reformulations of approved drugs being repurposed for COVID19’. Understanding what these patents are, and how they are related to Unitaid’s strategy, will help us to understand why they keep making an appearance.
The patents he describes are held by the University of Liverpool but licensed to a commercial company, Tandem Nano Ltd, for which Andrew Owen is a shareholder. As I previously reported, Tandem Nano was also listed as a recipient of the $40 million Unitaid funding handed out in 2019. The huge funding performed two roles, it helped Unitaid to nudge the regulatory process in their favour, and it stimulated the production of more patents in the space of “long-acting injectable drug technology”.
Why is that of interest? Let’s take a look.
Here is one of those patents; a pro-drug technology to deliver “nucleoside reverse transcriptase inhibitor (NRTI) therapy”. It’s held by the University of Liverpool, licensed to Tandem Nano. In laymen’s terms, this NRTI technology which Unitaid have invested their $40 million into is a kind of injectable drug implant. Active ingredients are loaded into a nanogel, and once inside the body, the gel is slowly metabolised and releases a steady dose of the active drug. The technology’s stated applications are for HIV, malaria, hepatitis C and tuberculosis. At CELT, the department inside the University of Liverpool doing the research, they say the technology is “agnostic to any disease area”.
It’s credible, interesting research with great potential. For HIV patients with a chronic need for antiretrovirals, the technology could hugely improve their quality of life. I’m not here to disparage research which can find a legitimate use case, but nothing in pharmaceuticals is straightforward. The huge funding complicates things because the technology could also be used to ‘upgrade’ generic drugs into novel ones. Remember, generic drugs are nearly impossible to profit from, but novel formulations are profitable.
Might it be the case that there’s interest from Unitaid and its partners in creating novel forms of ‘vaccine like’ Ivermectin? It is a drug being repurposed for treating SARS-CoV-2, so it fits with Andrew Owen’s stated declaration of interest. Reformulating Ivermectin into an injectable form would create a novel product, a patentable, profitable product. As things stand now, Ivermectin is generic which means drug companies struggle to profit from it.
Reformulating the generic into the profitable is, unsurprisingly, a common practice in the pharmaceutical industry. Paxlovid, Pfizer’s darling novel SARS-CoV-2 anti-viral is just two generic medications bundled together. Its novel status allows Pfizer to charge upwards of 100x markup, a profit margin totally dependent on strongarming regulators into approving the novel formulation over combining the generic ones for themselves. Reformulating effective generic drugs into profitable products is bread and butter for the pharmaceutical industry.
If you fear I’ve gone off at the deep end on speculation, then allow me to root this line of reasoning firmly into reality. There’s a company in France called Medincell, and they are doing exactly what I describe. They aim to create “an injectable long-acting formulation of Ivermectin based on the proprietary BEPO® technology.” Their focus sounds almost identical to Tandem Nano’s “long-acting injectable drug technology.” So what about Medincell? Who is funding their investigation into ‘long-acting’ injectable forms of Ivermectin?
It’s Unitaid of course. They granted Medincell $6.4 million over three years to research injectable Ivermectin. You can watch their confident product demonstration below.
For a drug which the regulators keep recommending against, often with Unitaid’s help, there’s a great deal of commercial interest in patenting it somehow. In fact, Unitaid funded Medincell is explicit in its interest in commercializing Ivermectin for Covid-19. The funding they receive from Unitaid is funnelled into long-acting Ivermectin for malaria, but as you can see they’re investigating Ivermectin as a treatment for Covid-19. Anyone with any real-world knowledge of grants knows that funding earmarked for X, can easily be funnelled towards Y. Unitaid must be aware that their client company Medincell are researching novel Ivermectin as a treatment for SARS-Cov-2, all the while Unitaid spend influence dollars to keep generic forms of Ivermectin out of treatment guidelines. Why?
With a demonstrated commercial interest in Ivermectin, controlling the narrative and regulatory decisions around the drug would be paramount for Unitaid and its partners. That includes the landscape that surrounds the drug, the beliefs that decision-makers have about it, and the regulatory framework. All of it needs to be tightly controlled. Why? Because there’s an ever-present danger that the efficacy of the generic version ‘escapes’ into common medical knowledge. Why would a low or middle-income country bother with a $10 novel ‘upscaled’ medical intervention if the generic $0.10 tablet works just as well?
Unitaid and Medincell are in a bind. They need the efficacy of the drug to be known, to some degree, but it must be known within a framework they can control so that they can bring novel formulations of the drug to market.
A desire to reformulate Ivermectin as a novel product via ‘Long Acting’ technology was a motive and theory I considered for some time, but to my surprise, I found that Unitaid has been quite explicit about “LA products” being a tool to get old drugs to new markets. In a document from 2018 called “Intellectual Property Report on Long-Acting Technologies”, Unitaid detailed opportunities in what they call ‘LA Products’, long-acting drug products. They beamed that “patents specific to the long-acting formulations often provide additional years of exclusivity beyond the expiry of the compound patents”.
Long-acting patents come as standard with long-acting injectables it seems. Which company could resist such riches?
But how does this all apply to the patents being developed by Unitaid through Tandem Nano and Medincell? How do these ‘long acting’ technology platforms fit into the picture? Again, Unitaid has been explicit in describing the role they play in getting new products onto the market.
“A number of nanotechnology platforms are owned by drug formulation companies that develop new formulations incorporating such technologies under contract. Such patent holders often grant a licence specific to a given product that incorporates its proprietary technology…
Some examples of industry platform technologies include NanoCrystal®, Medisorb®, BEPO®, NanoPure® and IDD-P®, to name just a few.
The technology platforms are often being applied to multiple products and are covered by extensive intellectual property protection”
Generic drugs in, novel products out. This seems to be the business model. As such, it helps Unitaid that they have a few ‘technology platforms’ on hand which would assist in the ‘novelification’ of drugs past their sell-by-date. Before they invested in the University of Liverpool, they pitched the drug delivery platform being developed there, a platform which might provide the handy “extensive intellectual property protection” required to create a novel product.
The Medicine Patent Pool, which collaborated with Unitaid on the document, seems to offer patent holders a way to protect and enhance the value of their intellectual property portfolio. The offer seems to be something like this, “you pay us, we manage your patents in low and middle-income countries, and we’ll ‘create the right market conditions’ to sell your products there”. Amongst other things, that might mean creating “new formulations and combinations” of existing drugs.
As early as 2018, Unitaid had identified Ivermectin as an ‘LA product’ opportunity, “Ivermectin long-acting injectable is marketed for veterinary use, but not yet for humans” it said, “no patent application was found in relation to the NIH-sponsored research at Colorado State University on the use of ivermectin for malarial control”. Two years later, and three months into the pandemic, Unitaid struck their deal with Medincell to investigate a long-acting formula of Ivermectin for malaria. Was it inconvenient for Unitaid that by December of that year, evidence was starting to emerge that Ivermectin in its generic form is effective against SARS-CoV-2? Would such information destabilise an entry into middle-income countries with their injectable Ivermectin formulation? Would they need to lobby against the drug in its generic form to protect the novel format?
Perhaps, perhaps, perhaps.
What we do know, is that two years on from the Unitaid ‘Ivermectin’ investment, and two years into the pandemic, Medincell announced medical trials of their injectable ‘SAIVE’ Ivermectin as prophylaxis for Covid-19. Inside the regulatory framework, there’s resistance to Ivermectin, but inside the pharmaceutical product world, it’s full steam ahead for the exact same compound. Would anyone be surprised to see Ivermectin in this form pass through the trials?
Understanding this as “a few bad actors” guarantees that we miss the scale of the problem we are facing. This is about pharmaceutical lobbying and a regulatory framework that allows an industry to emerge out of patent trolling. Unitaid masks their actions in a kind of ‘greenwash’ of charitable development of low and middle-income countries. That language has acted as the perfect fig leaf for the hypocrisy hiding underneath; funding research into novel ivermectin whilst lobbying against generic ivermectin. Ensuring the ‘right’ regulatory decisions are arrived at has come at a huge mortality cost.
Great job, Phil. I’d heard about Medincell over a year ago and what they were up to with ivermectin. You did this story justice. Prison orange would be appropriate for all the people who shat upon oral ivermectin while hundreds of thousands died needlessly and that’s just in my country of the USA.
Excellent work. ‘The thot continues to plicken’ 😉