Part 1: A Review of 2021 Product Approvals
Part 2: Notable Drug Delivery and Formulation Product Approvals and Technologies of 2021
Part 3: Drug Delivery and Formulation Pipeline Trends

By: Kurt Sedo, Vice President Operations, and Esay Okutgen, PhD, Director Drug Delivery, PharmaCircle LLC

Introduction

It appears the industry’s attention has moved on from gene therapy and mRNA. Despite remarkable commercial and therapeutic successes, both platforms are searching for their “second acts.” In 2021, attention returned to drug delivery- and formulation-based products and technologies applicable to larger patient populations and more diverse indications.

The notable approved drug delivery- and formulation-enabled and approved products of 2021 include Ascendis’ weekly human growth hormone product Skytrofa, and Janssen’s 6-month formulation of paliperidone aptly named Invega Hafyera, both variations on earlier themes. The list also includes a trio of products targeted to ophthalmic indications, Oyster Point’s Tyrvaya, J&J’s ACUVUE Theravision, and Genentech’s Susvimo, the latter representing first approvals for their novel delivery platforms. ViiV’s Cabenuva Kit rounds out the list delivering sustained-release depot therapy to the HIV patient population.

Platform technology best describes the notable technologies of 2021. Included are Genentech’s Port Delivery System that underlies its Susvimo product, a notable product of 2021, providing important dosing options for their well-validated AMD treatment ranibizumab. Medicago’s Virus Like Particles (VLP), with the approval of their first product, a COVID-19 vaccine, demonstrates the prospects of the platform for additional vaccines and therapeutics. Ionis’s LICA technology further refines the potential of oligonucleotides by providing greater selectivity and improved efficiency. The Denali Transport Vehicle (TV) platform, currently at a Phase 2 stage of development, includes four separate technologies intended to provide facilitated crossing of the blood-brain-barrier by antibody, enzyme, oligonucleotide, and protein therapeutics. At an earlier stage of development, LaGalli’s MedRing platform integrates a pump, liquid drug reservoir, and electronics to permit a connected “intelligent” vaginal ring delivery system for both therapeutic and diagnostic applications.

The stars of the past couple of years, gene and cell therapy technologies, as well as mRNA delivery platforms, are struggling to move beyond a few highly specialized therapeutic uses. Gene therapy is facing safety and durability concerns while mRNA searches for validation outside of the field of vaccines. Both platforms continue to earn significant industry interest as evidenced by transaction activity and litigation related to the underlying intellectual property.

Even in an age of disruption, the pharmaceutical industry continues to demonstrate remarkable resilience and innovation. COVID too will pass. Click here to download/view the entire report.