PolyPid Announces Exclusive Licensing Agreement With Advanz Pharma

PolyPid Ltd. recently announced it has entered into an exclusive licensing agreement with ADVANZ PHARMA Corp.  for the commercialization of its lead drug candidate, D-PLEX₁₀₀ for the prevention of surgical site infections (SSIs) in abdominal and cardiac surgeries, in Europe.

Under the terms of the agreement, PolyPid will receive an upfront payment immediately upon signing and additional development-related milestones for a total of up to $23.5 million as follows: upfront payment of $2.6 million, up to $12.5 million contingent upon positive top-line results of SHIELD I Phase 3 study and additional development-related milestones of up to $8.4 million. Upon commercialization, PolyPid will receive up to $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.

“We are very pleased to collaborate with ADVANZ PHARMA to commercialize D-PLEX₁₀₀ in Europe,” said Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “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.”

Steffen Wagner, Chief Executive Officer of ADVANZ PHARMA, added “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.”

PolyPid recently announced the completion of enrolment 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.

 PolyPid’s lead product candidate, 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, resulting 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. D-PLEX₁₀₀ has received Breakthrough Therapy Designation from the US 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.

ADVANZ PHARMA is a global pharmaceutical company with a strategic focus on specialty and hospital medicines in Europe and Canada. The company has commercial affiliates in Europe, North America and Australia, and a Centre of Excellence in Mumbai, India, as well as an established global network of commercial partners throughout the rest of the world. With an agile and experienced team, including direct sales, marketing, and medical capability across Europe’s major markets and Canada, ADVANZ PHARMA is committed to improving lives of patients by providing and enhancing the specialty and hospital medicines they depend on. The company has a broad expertise in several therapeutic areas including hepatology, gastroenterology, critical care, anti-infectives, endocrinology, oncology, and more broadly rare disease medicines, making ADVANZ PHARMA a partner of choice for the commercialisation of specialty and hospital pharmaceuticals. For more information, visit our Website or Linkedin.

PolyPid Ltd. is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid’s lead product candidate D-PLEX₁₀₀ is in Phase 3 clinical trials for the prevention of soft tissue abdominal and sternal bone surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for treatment of solid tumors, beginning with glioblastoma. For more information, visit http://www.polypid.com.