PolyPid Ltd. (NASDAQ: PYPD) has entered into an exclusive commercial partnership with Azurity Pharmaceuticals for the commercialization of D-PLEX100 in the United States and Canada, according to a company press release.

Under the agreement, 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, which is expected in August 2026. PolyPid is eligible to receive up to approximately $300 million in additional regulatory, development, and sales-based milestone payments, bringing the total potential value to more than $320 million. PolyPid will also receive tiered royalties ranging from mid-teen to mid-twenties percentages upon commercialization.

Azurity, a privately held specialty pharmaceutical company, will be responsible for commercializing D-PLEX100 if it receives FDA approval, while PolyPid will manufacture and supply the product. Azurity will also fund clinical development for potential label expansion beyond abdominal surgery indications in the U.S. and Canada.

A U.S. commercial launch is targeted for the first quarter of 2027.

D-PLEX100 is designed to deliver controlled, prolonged release of the antibiotic doxycycline at the surgical site for 30 days to prevent surgical site infections. The product received Breakthrough Therapy Designation from the FDA for prevention of surgical site infections in patients undergoing elective colorectal surgery. In the Phase 3 SHIELD II trial, D-PLEX100 met its primary endpoint and demonstrated a 60% relative risk reduction at the secondary endpoint in surgical site infection incidence following abdominal colorectal surgery.

PolyPid retains global commercial rights to D-PLEX100 outside the U.S. and Canada, worldwide manufacturing rights, and full ownership of its PLEX platform and Kynatrix technology.