A drug to prevent surgical site infections (SSIs) in abdominal and cardiac surgeries in Europe is to be commercialized after two companies entered an exclusive licensing agreement.
Israel-based PolyPid Ltd and UK-based ADVANZ PHARMA Corp. announced the agreement for lead drug candidate D-PLEX100 yesterday (August 3).
Topline results
Under the terms of the agreement, PolyPid will receive an upfront payment immediately upon signing. It will receive additional development-related milestones for a total of up to $23.5 million: An upfront payment of $2.6 million, up to $12.5 million, contingent upon positive topline results of a SHIELD I phase 3 study, and additional development-related milestones of up to $8.4 million is also expected to be exchanged.
Steffen Wagner, CEO at ADVANZ PHARMA, said: “We are very excited by the potential of D-PLEX100 to effectively prevent SSIs and improve patient outcomes. D-PLEX100 is expected to be an important growth driver for ADVANZ PHARMA. The collaboration with PolyPid is in line with our strategy for the commercialization of specialty and hospital pharmaceuticals in Europe.”
When D-PLEX100 is commercialized, PolyPid will receive $89 million in sales-related milestones. In addition, the company will also supply D-PLEX100 to ADVANZ PHARMA for a transfer price and will be entitled to royalties on net sales in double-digit percentages of up to mid-twenties.
Collaborate
Dikla Czaczkes Akselbrad, PolyPid’s CEO said: “We are very pleased to collaborate with ADVANZ PHARMA to commercialize D-PLEX100 in Europe. ADVANZ PHARMA’s expertise in marketing hospital-based therapies, combined with its significant resources and relationships in the region, will prove invaluable in expanding access to D-PLEX100 and delivering this much-needed therapy, if approved, to patients.
“We are also in active discussions with multiple large and mid-size potential strategic partners, all with significant presence and experience selling in hospitals and operating rooms, to potentially commercialize D-PLEX100 in additional geographies.”
PolyPid recently announced the completion of enrollment of its SHIELD I phase 3 study of D-PLEX100 for the prevention of SSIs in abdominal surgery, with top-line results expected by the end of the current quarter.
Doxycycline
D-PLEX100 is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with active pharmaceutical ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline.
This results in high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site.
Prevention
D-PLEX100 has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the prevention of SSIs in patients undergoing elective colorectal surgery.
D-PLEX100 has also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.