PolyPid has entered into an exclusive partnership with Azurity Pharmaceuticals to commercialize D-PLEX₁₀₀ in the United States and Canada for the prevention of surgical site infections. The agreement could provide PolyPid with more than $320 million in upfront and milestone payments, along with tiered royalties on future sales.
PolyPid will receive $15 million upon signing and another $15 million if the U.S. Food and Drug Administration accepts the company’s New Drug Application for D-PLEX₁₀₀. FDA acceptance is expected in August 2026.
The company is also eligible for approximately $300 million in additional regulatory, development and sales milestones. Once the product is commercialized, PolyPid will manufacture and supply D-PLEX₁₀₀ to Azurity for a transfer price and receive royalties ranging from the mid-teens to the mid-20% range.
Azurity will lead commercialization in the U.S. and Canada if D-PLEX₁₀₀ receives regulatory approval. PolyPid will retain commercial rights across all other global markets, worldwide manufacturing rights and full ownership of its PLEX platform, Kynatrix technology and associated pipeline.
The companies may also jointly pursue additional surgical site infection indications beyond abdominal procedures. Azurity would fund the clinical development required to support those potential label expansions in the U.S. and Canada.
D-PLEX₁₀₀ is designed to provide prolonged and controlled antibacterial activity directly at a surgical site. The product uses PolyPid’s Kynatrix drug-delivery technology to release the broad-spectrum antibiotic doxycycline continuously for approximately 30 days.
Delivering the antibiotic locally is intended to maintain a high concentration at the surgical site while preventing infections, including those potentially caused by antibiotic-resistant bacteria. Surgical site infections can lead to longer hospital stays, repeat procedures and additional treatment costs.
The partnership follows positive results from the Phase 3 SHIELD II trial involving patients undergoing abdominal colorectal surgery with large incisions. D-PLEX₁₀₀ met the study’s primary endpoint and produced a 60% relative reduction in surgical site infection incidence at a secondary endpoint.
D-PLEX₁₀₀ has also received FDA Breakthrough Therapy Designation for preventing surgical site infections in patients undergoing elective colorectal surgery. The designation is intended to support the development and review of therapies addressing serious conditions when preliminary evidence suggests a meaningful improvement over available treatment.
PolyPid recently completed its NDA submission to the FDA. Subject to regulatory approval, the companies are targeting a U.S. commercial launch during the first quarter of 2027.
The agreement gives PolyPid access to Azurity’s commercial infrastructure while allowing the company to continue manufacturing D-PLEX₁₀₀ and retain rights outside North America. PolyPid expects the upfront capital and potential milestone payments to strengthen its financial position and support continued investment in its broader drug-development pipeline.
Azurity has a portfolio of more than 50 medicines across 10 therapeutic areas and reaches patients in over 50 countries. The privately held pharmaceutical company focuses on specialized therapies and delivery models designed to address practical challenges in patient care.
KEY QUOTES:
“This partnership is a defining step in PolyPid’s transition into a commercial-stage company, and Azurity is the right partner to bring D-PLEX₁₀₀ to U.S. and Canadian patients, hospitals and surgeons.”
“We believe that Azurity’s first-in-class commercial model and demonstrated commercial execution will be invaluable in expanding access to D-PLEX₁₀₀, if approved. Importantly, this collaboration represents a meaningful validation of our unique platform, and allows us to fully realize the U.S. and Canadian commercial value of D-PLEX₁₀₀ while putting us in a position of financial strength to continue investing in our Kynatrix technology, pipeline, and the next generation of therapies.”
Dikla Czaczkes Akselbrad, CEO of PolyPid
“At Azurity, we believe meaningful innovation is measured by the difference a therapy makes in the realities of patient care. D-PLEX₁₀₀ is a differentiated therapy addressing an important unmet need, and we are excited to partner with PolyPid to help bring it to patients in the United States and Canada, if approved.”
“Our commercial model was built to support specialized therapies like this, connecting the right treatment to the right healthcare professionals and patients through efficient, focused execution. Together, we believe we can expand access to an important new option while exploring opportunities to broaden its impact in the years ahead.”
Ronald Scarboro, CEO of Azurity Pharmaceuticals
