PolyPid partners with Azurity to commercialize D-PLEX100 in U.S. and Canada

PolyPid Ltd. announced on July 21, 2026 that it entered into an exclusive commercial partnership with Azurity Pharmaceuticals for D-PLEX100 in the United States and Canada, aimed at preventing surgical site infections. According to the companies' filing, the agreement, dated July 17, 2026, was structured as a License and Supply Agreement with Azurity Pharmaceuticals Ireland Ltd., granting Azurity exclusive rights to commercialize D-PLEX100 in the U.S. and Canada.¹ The agreement runs for 20 years from its effective date and can be terminated by either party under certain limited circumstances.¹

Financially, PolyPid will receive a $15 million upfront payment upon signing and an additional $15 million milestone payment upon FDA acceptance of the D-PLEX100 New Drug Application, expected in August 2026.¹ PolyPid is eligible for up to approximately $300 million in additional regulatory, development, and sales-based milestones.¹ Once commercialized, PolyPid will manufacture and supply the product to Azurity at a transfer price and receive tiered royalties ranging from mid-teen to mid-twenties percentages.¹

The parties may also jointly pursue label expansion into additional SSI indications beyond abdominal surgery, with Azurity funding related clinical development.¹ PolyPid retains global commercial rights outside the U.S. and Canada, worldwide manufacturing rights, and full ownership of its PLEX platform and Kynatrix technology.¹

The release cited supporting clinical data: in the Phase 3 SHIELD II trial, D-PLEX100 achieved its primary endpoint and showed a 60% relative risk reduction (p=0.0013) at the secondary endpoint for SSI incidence following abdominal colorectal surgery with large incisions.¹ D-PLEX100 has received Breakthrough Therapy Designation from the FDA for prevention of SSIs in elective colorectal surgery patients.¹ The companies said a U.S. launch is targeted for the first quarter of 2027, as stated in the release.