Issue:March 2021
GLOBAL REPORT - 2020 Global Drug Delivery & Formulation Report: Part 1, a Global Review
Part One of a Four-Part Series
Part 1: A Review of 2020 Product Approvals
Part 2: Notable Drug Delivery and Formulation Product Approvals of 2020
Part 3: Notable Drug Delivery & Formulation Transactions and Technologies of 2020
Part 4: The Drug Delivery and Formulation Pipeline
By: Kurt Sedo, Vice President Operations, PharmaCircle LLC
Introduction
If the Pharmaceutical Industry ever needed a reminder of how important resilience and formulation capabilities were, last year provided convincing evidence. The emergence of COVID-19 has placed a heavy burden on society and the industry. This was particularly evident with the two COVID-19 vaccines that were approved in record time for Emergency Use in the US, BioNTech and Pfizer’s Comirnaty and the Moderna COVID-19 Vaccine. While both products reported outstanding clinical results, they have put heavy demands on distribution systems and end-user storage. Comirnaty requires storage at -70°C during transportation and storage. Moderna’s vaccine’s demands are somewhat less demanding, -20°C, but still strain current infrastructure. These demands are particularly problematic with a need to ship what will eventually be billions of doses.
Formulation should be coming to the rescue as soon as the third quarter of 2021 when it is hoped that lyophilized
presentations of both vaccines might be available. There is also a hope that some of the newer vaccines in development, and probably approved for emergency use by the time this article is published, will require only a single dose, cutting transportation issues in half, and perhaps less-stringent temperature management demands.
In the world of Drug Delivery, there were no first products approvals using breakthrough technologies as there was in 2019 with the approval of Novo Nordisk’s Rybelsus. Rybelsus was, however, approved in both Europe and Japan in 2020, and its label was expanded in the US. Halozyme’s Enhanze technology was also well represented in 2020, with new drug approvals for Janssen’s Darzalex FasPro and Genentech’s Phesgo, new formulations of previously approved products that provide for the convenience of simple and quick subcutaneous injections rather than hours-long infusions. These two product improvements not only benefit patients and caregivers, but also the companies by quite likely extending their periods of market exclusivity.
Despite all of the challenges of 2020, the regulatory authorities didn’t seem to miss a beat. Approvals were at much the same level as 2019. Most, if not all, of the submissions approved in 2020 would have been fi led prior to the pandemic, meaning the pressure was on the regulatory authorities to appropriately reconfigure their resources with all of the challenges of social distancing.
What isn’t yet apparent is how product development was impacted by the pandemic. Some companies certainly would have had resources reallocated to COVID-19 vaccines and therapeutics development. Social distancing and the application of medical resources to treating COVID-19 patients would have impacted all companies. The FDA also had to deal with restrictions on travel to conduct preapproved inspections.
Looking at the approval data on the following pages it’s hard to imagine that the pandemic had any impact on the pharmaceutical industry. Next year’s data may tell a different story.
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