Issue:April 2021

GLOBAL REPORT – 2020 Global Drug Delivery & Formulation Report: Part 2, Notable Drug Delivery and Formulation Product Approvals of 2020

Part Two 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

Drug Delivery and Formulation is increasingly becoming as much an opportunity to creatively apply available technology to existing therapeutic challenges as it is to develop novel technology. This past year presented examples of both.

The most notable new products of 2020 were the first two COVID-19 vaccines to be introduced for clinical use,
Pfizer/BioNTech’s Comirnaty and the Moderna COVID-19 Vaccine. These products depended on a novel mechanistic approach, the use of mRNA to express antigen proteins, and novel technologies to deliver these therapeutics in sufficient quantities to the nucleus of cells.

Also notable was the approval of two antibody-based products, Janssen Biotech’s Darzalex FasPro and Roche’s Phesgo. Both products used Halozyme’s well-validated Enhanze formulation technology to turn hours-long infusions into much more patient-friendly subcutaneous injections. The applications may have been obvious to some, but the development work was done remarkably quickly, with both products taking about 4.5 years from first clinicals to approval.

Mycapssa from Chiasma joined a very short list of approved oral peptides. A combination of oral absorption enhancer and enteric liquid-filled capsule technologies were necessary to provide the quantities of octreotide required to provide a therapeutic benefit for the treatment of acromegaly. Following on last year’s approval of Rybelsus, Mycapssa provides additional validation for the oral administration of peptides.

The notability of Jazz’s Xywav, an oral liquid formulation of calcium, magnesium, potassium, and sodium oxybates, revolves more around concept than formulation. By eliminating a problematic sodium issue with their blockbuster Xyrem product but retaining the same dosage form and instructions, Jazz Pharmaceuticals has provided an important patient benefit and given the company an extended commercial runway. It doesn’t necessarily take sophisticated technology breakthroughs to meaningfully address real-world patient needs.

A shout out goes to two products that used relatively pedestrian technologies to address real-world patient needs. The first, Hanmi Pharmaceuticals’ Amosartan XQ Oral Tablets, combines four multisource cardiovascular agents into a single oral tablet for the treatment of hypertension and hyperlipidemia, making it much easier for patients to be compliant. Mallinckrodt’s Gimoti Nasal Spray for diabetic gastroparesis provides metoclopramide in a delivery form that doesn’t depend on reliable enteral absorption without the need for an injection.

A common theme over the past few years has been the realization that innovation in the drug delivery and formulation space is as dependent on creative ideas using existing technology than it is waiting for the next big technology breakthrough. In next month’s report, we will take a look at exactly what is new and exciting in the area of drug delivery technologies. Click here to download/view part 2 of the entire report.