New uses for old drugs: the benefits of reformulation

Pharmanovia’s business model is rather different to most pharmaceutical businesses. Rather than focusing on developing new drugs, the company specializes in reformulating and acquiring existing medications, in some cases redeveloping products that would otherwise be discontinued.

We spoke to Pharmanovia’s CEO Dr James Burt about how this model benefits revenues and decreases time-to-market, and why it is especially invaluable while the war in Ukraine and other geopolitical issues impact access to medicines around the world.

Pharma IQ: What are Pharmanovia’s areas of focus?
James Burt: Our therapeutic specialisms are cardiovascular, oncology, endocrinology and neurology. Our mission is to revitalize iconic medicines for the benefit of patient health globally.

We do this through acquisition or in-licensing complementary products, or through redeveloping and reformulating medicines, taking advantage of advances in healthcare to better manage side effects, improve the way patients take medicines or by investing in solutions to empower patients to take medication more effectively. These are all huge challenges for the healthcare industry, which if done properly have significant benefits for patients, prescribers and healthcare systems.

Pharma IQ: Given how expensive and time-consuming drug development is, why are more pharma companies not focusing on drug reformulation?
JB: I think a large portion of the reason is that pharmaceutical companies are focused on the big breakthroughs we saw in the 1980s, 1990s and early 2000s. During this time, several products were brought to market which had a huge impact on patients. Statins and alpha blockers are two examples, these are medicines which are effective and reliable.

However, now that medicines have been successfully developed for some of the more common conditions, the pharmaceutical industry has found itself spending huge amounts on research and development for less common illnesses. That’s why our business model is all about providing incremental innovation to older, more established medicines, instead of spending inordinate amounts of time and money seeking those new “breakthrough” medicines.

Pharma IQ: How does reformulating drugs benefit pharma companies in terms of revenue?
JB: Essentially it comes down to the fact that creating whole new drugs from scratch, with all the research and development required to do so, is not only incredibly time-consuming with a high risk of failure, it is also very expensive, both for the pharma company but also ultimately, the healthcare systems that pay for the drugs. If you can make similar breakthroughs and achieve extremely positive patient outcomes through innovation and evolution, then that is always going to help revenue, as the expense of bringing the drug to market is drastically reduced but more importantly – it is going to continue to provide various ways to help patients.

Pharma IQ: How has the war in Ukraine impacted drug research and supply?
JB: The Ukraine war has affected an estimated five percent of clinical trials globally, so the impact has undeniably been huge for research. For just one example, the US Food and Drug Administration (FDA) has said that as many as 250 drugs and devices were being tested in Ukraine, while Informa's Citeline database had more than 1,000 current and planned clinical trials in the country. The conflict has put a stop to these as it is simply too dangerous to continue to conduct these in a warzone.

The effects of this will be felt long-term, as the drugs will take years longer to come to market. But not only that, there is a fear that the outcome of the conflict will encourage companies to deglobalize and run trials in fewer regions, which would greatly affect trial diversity.

When it comes to supply, of course there have been huge issues in getting drugs to those who need them in Ukraine. Beyond the fatalities of war and those injured and in need of medical care, patients with chronic and critical conditions have struggled to access the medicines they require, such as insulin or life-saving machinery like defibrillators, ultrasound machines, cardiac monitors and ventilators.

This issue isn’t isolated to Ukraine either, it is affecting the wider region. Both the Ukrainian and Russian pharmaceutical markets have been crucial for the development and distribution of medical supplies to the whole region. Of course, pharmaceutical companies are doing everything they can to ensure patients do not suffer, but it is a huge issue right now and one without easy fixes.

Pharma IQ: What other challenges could impact drug availability in the near future?
JB: I think the Ukraine war is simply a symptom of a worrying trend of the collapse of the globalized economy. For years now, the world has been getting smaller and more interconnected – to the point of reliance on one another. Not just within trading blocs such as the EU, but worldwide economies are interlinked and intrinsically connected. This has been fantastic for drug availability as nations have been able to make new drug breakthroughs available worldwide – just look at the Covid-19 vaccine roll out.

There is a danger that when the free flow of goods stops and that interconnectedness is interrupted, it can have far-reaching and devastating consequences on the drug supply chain. Supplier risk across the entire supply chain as a result of inflation could force some organizations out of business.

We are also seeing the impact of soaring energy and input costs over the last 12-18 months coupled with geopolitical unease which is presenting new challenges for the industry. Pharma businesses have reported difficulties in sourcing raw materials, single-use consumables and critical chemicals, factors that have once again forced the wider sector to innovate, improvise, and to focus on resilience over efficiency across the board.

Pharma IQ: How do you see this area of pharma evolving in the next three to five years?
JB: I think increasingly we will start to see more drug reformulation happening across the industry. We are already seeing support for incremental innovation from policy makers and regulators. It is undeniable that it is good for patient outcomes and at the end of the day, that is at the core of what we do.

There is a growing culture of recycling and repurposing across all industries. Instead of constantly trying to chase the shiny new idea, we should be putting the patient experience front and center to understand where there is opportunity to improve existing medicines for patients. I think it is only a matter of time before that becomes more and more widespread amongst the pharmaceutical industry.

Quick links

• The benefits of drug reformulation
• Ukraine's clinical trials still recruiting despite ongoing war
• Tackling infectious disease with innovative R&D approaches

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