Full Press Release Details
Announces Exclusive Licensing Agreement with ADVANZ PHARMA for the Commercialization of D-PLEX100 in Europe
to potentially receive over $110 million in upfront and milestone payments as well as royalties on net sales
PHARMA to receive exclusive rights to commercialize D-PLEX100 for the prevention of surgical site infections in abdominal
and cardiac surgeries in Europe, leveraging its specialty and hospital footprint
TIKVA, Israel, August 3, 2022 - PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage
biopharma company aiming to improve surgical outcomes, today announced that it has entered into an exclusive licensing agreement with
ADVANZ PHARMA Corp. ("ADVANZ PHARMA"), a UK-based global specialty and hospital pharmaceutical company, 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.
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.
are very pleased to collaborate with ADVANZ PHARMA to commercialize D-PLEX100 in Europe," stated 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."
Wagner, Chief Executive Officer of ADVANZ PHARMA, commented: "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."
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.
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 U.S. 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.
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.
more information, please visit our Website or Linkedin.
Ltd. (Nasdaq: PYPD) 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 additional company information, please visit http://www.polypid.com and follow
us on Twitter and LinkedIn.
and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference
into this press release. PolyPid is not responsible for the contents of third-party websites.
press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and
other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes,"
"seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking
statements. For example, the Company is using forward-looking statements when it discusses the total potential payments under the licensing
agreement with ADVANZ PHARMA, expanding access to D-PLEX100 and delivering the therapy, if approved, to patients, the Company's
discussions with potential strategic partners, potential commercialization of D-PLEX100 in additional geographies, the potential
of D-PLEX100 to effectively prevent SSIs and improve patient outcomes, the possibility of bringing Company's product candidate
to the European hospital markets, Advanz Pharma's expectation that D-PLEX100 will be an important growth driver for
ADVANZ PHARMA, and the Company's expectation to report top-line results of the SHIELD I Phase 3 study by the end of the current
quarter. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and
projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good
faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual
results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are
subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking
statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's
reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks
detailed in the Company's Annual Report on Form 20-F filed on February 28, 2022. Forward-looking statements speak only as of the
date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent
events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent
required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn
that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.
and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference
into this press release. PolyPid is not responsible for the contents of third-party websites.
amounts used in this press release are in $US and were converted from Euros based on an exchange rate of 1.02.
ADVANZ media enquiries, please contact:
Communications Manager