Pharma Ramps Up R&D Into Abuse-Deterrent Painkillers
The race is on to create safer painkillers, which are difficult to abuse. A landmark ruling by the FDA sees more than a dozen pharma companies – from small startups to Pfizer – vying to develop a painkiller than is hard to abuse.
Last month, the FDA moved to block the manufacture and sale of generic versions of the original OxyContin, which has gone off patent but which is easier to abuse than the current version. A newer version of OxyContin, introduced by its maker, Purdue Pharma LP, in 2010, contains an infusion of polymer that makes the pill difficult to crush, meaning addicts can't get all of the extended-release ingredients at once to get high.
Similarly, this week the FDA is considering the effectiveness of another safeguarded, brand-name painkiller, Endo Pharmaceuticals Opana ER. If the FDA rules that Opana ER slows abuse, the agency can choose to shield Endo from the competition, because the generic options don’t have abuse-deterrents.
Such a decision would send a strong message to pharma manufacturers, that pain drugs with no safeguards are likely to be removed from the market—and that there are billions of dollars in potential revenue to be had from the sale of painkillers that are abuse proof.
Creating An Abuse Proof Painkiller
With such a ruling in the pipeline, companies such as Pfizer, Johnson and Johnson and Endo are trying to crack the potentially lucrative market.
- Pfizer wants to introduce Remoxy, a direct OxyContin competitor with abuse deterrents, and a morphine drug called Embeda.
- Johnson & Johnson is conducting tests to demonstrate abuse-deterrent properties of its opioid for moderate to severe pain.
- Purdue Pharma wants to adapt its abuse-deterrent technology for a hydrocodone product—a class of drugs currently dominated by low-cost generics that don't have abuse-proof formulations.
“Over time, it should be a scientific race across the whole pharmaceutical industry to create a market where all opioids have abuse-deterrent properties,” said Gary L. Stiles, Senior Vice-President of Research and Development at the closely held Purdue Pharma.
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The race could give a boost to an already lucrative market and raise the cost of pain treatment. A recent Cowen & Co. report predicts an increase in prescription pain drug sales of more than 15 percent by 2017, reaching $8.4 billion, thanks in part to the FDA ruling. It could also bring about a reshuffling of market share in the fast-growing $7.3 billion pain market, as companies such as Pfizer move with full force in the opioid painkiller market for the first time.
The FDA isn't directly requiring all painkillers to have safeguards. But should an effective abuse-deterrent drug be developed, the FDA said it has the power to remove on-the-market rival products, which don't.
With this in mind many of the world’s pharma giants are ramping up their R&D when it comes to finding and implementing effective abuse-deterrents.
The challenges to vaccine distribution affecting everyone
While it is comforting to know that vaccines against COVID-19 are showing remarkable efficacy, the world still faces intractable challenges with vaccine distribution. Specifically, the sheer number of vaccines required and the complexity of global supply chains are sure to present problems we have neither experienced nor even imagined.
Current projections estimate that we could need 12-15 billion doses of vaccine, but the largest vaccine manufacturers produce less than half this volume in a year. To understand the scale of the problem, imagine stacking one billion pennies – you would have a stack that is 950 miles high. Now, think of that times ten. This is a massive problem that one nation can’t solve alone.
Even if we have a vaccine – can we make enough? Based on current projections, Pfizer expects to produce up to 1.3 billion doses this year. Moderna is working to expand its capacity to one billion units this year. Serum Institute of India, the world’s largest vaccine producer, is likely to produce 60% of the 3 billion doses committed by AstraZeneca, Johnson & Johnson and Sanofi. This leaves us about 7 billion doses short.
Expanding vaccine production for most regions in the world is complicated and time-consuming. Unlike many traditional manufacturing operations that can expand relatively quickly and with limited regulation, pharmaceutical production must meet current good manufacturing practice (CGMP) guidelines. So, not only does it take time to transition from R&D to commercial manufacturing, but it could also take an additional six months to achieve CGMP certification.
The problem becomes even more complex when considering the co-products required. Glass vials and syringes are just two of the most essential co-products needed to produce a vaccine. Last year, before COVID-19, global demand for glass vials was 12 billion. Even if it is safe to dispense ten doses per vial, there is certain to be significant pressure on world supply of the materials needed to package and distribute a vaccine.
It is imperative drug manufacturers and their raw material suppliers have clear visibility of production plans and raw material availability if there is any hope of optimizing scarce resources and maximising production yield.
It is widely known by now that temperature is a critical factor for the COVID-19 vaccine. Even the regions with the most developed logistics infrastructures and resources needed to support a cold-chain network are sure to struggle with distribution.
For the United States alone, State and local health agencies have determined distribution costs will exceed $8.4 billion, including $3 billion for workforce recruitment and training; $1.2 billion for cold-chain, $1 billion vaccination sites and $0.5 billion IT upgrades.
The complexity of the problem increases further when considering countries such as India that do not have cold-chain logistics networks that meet vaccine requirements. Despite India’s network of 28,000 cold-chain units, none are capable of transporting vaccines below -25°Celsius. While India’s Serum Institute has licensed to manufacture AstraZeneca’s vaccine, which can reportedly be stored in standard refrigerated environments, even a regular vaccine cold chain poses major challenges.
Furthermore, security will undoubtedly become a significant concern that global authorities must address with a coordinated solution. According to the Pharmaceutical Security Institute, theft and counterfeiting of pharmaceutical products rose nearly 70% over the past five years. As with any valuable and scarce product, counterfeits will emerge. Suppliers and producers are actively working on innovative approaches to limit black-market interference. Corning, for example, is equipping vials with black-light verification to curb counterfeiting.
Clearly, this is a global problem that will require an unprecedented level of collaboration and coordination.
Disconnected information systems
While it is unreasonable to expect every country around the world will suddenly adopt a standard technology that would provide immediate, accurate and available information for everyone, it is not unreasonable to think that we can align on a standard taxonomy that can serve as a Rosetta Stone for collaboration.
A shared view of the situation (inventory, raw materials, delivery, defects) will provide every nation with the necessary information to make life-saving decisions, such as resource pooling, stock allocations and population coverage.
By allowing one central authority, such as the World Health Organization, to organize and align global leaders to a single collaboration standard, such as GS1, and a standard sharing protocol, such as DSCSA, then every supply chain participant will have the ability to predict, plan and execute in a way that maximises global health.
Political influence and social equality
As if we don’t have enough stress and churn in today’s geopolitical environment, we must now include the challenge of “vaccine nationalism.” While this might not appear to be a supply chain problem, per se, it is a critical challenge that will hinge on supply chain capabilities.
In response to the critical supply issues the world experienced with SARS-CoV-2, the World Health Organization, Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI) formed Covax: a coalition dedicated to equitable distribution of 2 billion doses of approved vaccines to its 172 member countries. Covax is currently facilitating a purchasing pool and has made commitments to buy massive quantities of approved vaccines when they become available.
However, several political powerhouse countries, such as the United States and Russia, are not participating. Instead, they are striking bilateral deals with drug manufacturers – essentially, competing with the rest of the world to secure a national supply. Allocating scarce resources is never easy, but when availability could mean the difference between life and death, it becomes almost impossible.
Global production, distribution and social equality present dependent yet conflicting realities that will demand global supply chains provide complete transparency and an immutable chain of custody imperative to vaccine distribution.
The technology is available today – we just need to use it. We have the ability to track every batch, pallet, box, vile and dose along the supply chain. We have the ability to know with absolute certainty that the vaccine is approved, where and when it was manufactured, how it was handled and whether it was compromised at any point in the supply chain. Modern blockchain technologies should be applied so that every nation, institution, regulator, doctor and patient can have confidence in knowing that they are making an impact in eradicating COVID-19.