Issue:May 2020

GLOBAL REPORT – 2019 Global Drug Delivery & Formulation Report: Part 3, Notable Drug Delivery & Formulation Transactions & Technologies of 2019

Part 3 of a Four-Part Series

Part 1: A Review of 2019 Product Approvals
Part 2: Notable Drug Delivery and Formulation Product Approvals of 2019
Part 3: Notable Drug Delivery and Formulation Transactions and Technologies of 2019
Part 4: The Drug Delivery and Formulation Pipeline

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

It was not so long ago when the drug delivery business model was “simple.” Big Pharma discovered the drug, and drug delivery companies provided the means to optimize its performance. Big Pharma took the risks of clinical development and commercialization, and reaped the rewards while drug delivery companies contented themselves with license fees, milestones, royalties, and hopes of landing additional partners for the same platform. The script has been flipped with the genomic revolution. For diseases with a well-understood genetic cause, discovering the “drug,” increasingly some sort of nucleic acid derivative, is becoming increasingly obvious. The real challenge is delivering these generally fragile therapeutics both safely and in sufficient amounts to very specific locations in very specific cells. No longer is drug delivery and formulation an improvement, it is a necessity.

Following a generation of technology commoditization, Big Pharma is once again looking for technologies to deliver these new therapeutics. Their preferred business model in dealing with “delivery” companies remains the same; license fees, milestones, and single-digit royalties, but these “delivery” companies, eschewing the label of Drug Delivery, are increasingly looking for a bigger piece of the action. With the success of smaller companies developing and commercializing new-generation therapeutics, Big Pharma has been forced to sweeten the deal.

This doesn’t mean there aren’t technology opportunities for small molecule therapeutics, but the opportunities and rewards have shrunk as technologies lose exclusivity and Big Pharma brings the necessary expertise in-house. The business for low-margin technologies has shifted to Service Companies that are content with lower license related fees in exchange for manufacturing and packaging margins.

This year, nine technologies were identified as “notable” by the Technology Team: Alnylam’s ESC-GalNAc Conjugate Delivery, Emisphere’s Eligen Technology, RegenexBio’s NAV Vectors, PharmaCyte’s Cell-in-a-Box, DBV’s ViaSkin, Ensai’s ImplaVax, Beta Bionics’ iLet Bionic Pancreas, Lyndra’s GR Oral Delivery, and Mati’s Punctal Drug Delivery. Of these, four are presented in more detail later in this review.

On the deal front, perhaps Dicerna’s deal with Novo Nordisk and Codiak Biosciences’ agreement with Jazz Pharmaceuticals, which are discussed further, best represent the new reality. Honorable mention goes out to Halozyme who inked another attractive Enhanze licensing deal with Argenx after stepping back from developing their own proprietary pipeline. Sometimes you need to play to your strengths. Click here to download/view part 3 of the entire report.