PolyPid, an Israeli biotech company, said on Tuesday it had agreed a deal with Azurity Pharmaceuticals to commercialize a drug aimed at preventing surgical site infections in the US and Canada, under which it could receive more than $320 million.
PolyPid said it will receive $15 million due upon signing and an additional near-term milestone payment of $15 million payable upon US Food and Drug Administration acceptance of its D-PLEX100 new drug application, which is expected next month.
The company said it would be eligible to receive up to some $300 million in additional regulatory, development and sales-based milestone payments. Upon commercialization of the drug, PolyPid will produce and supply D-PLEX100 to Azurity for a transfer price and will be entitled to tiered royalties.
What is D-PLEX100?
D-PLEX100 is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site with the goal of preventing abdominal surgical site infections.
The partners may agree to jointly pursue potential label expansion of D-PLEX100 in the US and Canada into additional infections beyond abdominal, with Azurity providing funding.
PolyPid will retain global commercial rights to D-PLEX100 outside the US and Canada, manufacturing rights worldwide, and full ownership of its PLEX platform, its Kynatrix technology, and associated pipeline assets.
"This partnership is a defining step in PolyPid's transition into a commercial-stage company," PolyPid CEO Dikla Czaczkes Akselbrad said in a statement.