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PolyPid Announces Exclusive Partnership with Azurity Pharmaceuticals for the Commercialization of D-PLEX₁₀₀ in the U.S. and Canada

PYPD
  • PolyPid will receive over $320 million in total potential payments, including $30 million in upfront & near-term milestones & tiered royalties from mid-teens to mid-twenties.
  • Azurity will commercialize D-PLEX 100 in the U.S. & Canada for preventing surgical site infections (SSIs) upon approval.
  • PolyPid will manufacture & supply D-PLEX 100 to Azurity under a transfer pricing agreement.
  • Azurity will fund clinical development for potential label expansion beyond abdominal surgery indications in the U.S. & Canada.
  • The partnership follows positive Phase 3 SHIELD II results showing a 60% relative risk reduction in SSI incidence.
  • PolyPid's New Drug Application (NDA) to the FDA was recently completed, with acceptance expected in August 2026.
  • The U.S. launch is targeted for the first quarter of 2027.
  • PolyPid retains global commercial rights outside the U.S. & Canada, worldwide manufacturing rights, & full ownership of its PLEX platform & Kynatrix technology.
  • D-PLEX 100 utilizes Kynatrix technology to provide 30 days of controlled doxycycline release at the surgical site.
  • D-PLEX 100 holds Breakthrough Therapy Designation from the FDA for preventing SSIs in elective colorectal surgery patients.