Spectral Medical Inc. and Baxter Healthcare Corporation have announced an extension to their exclusive supply and distribution agreement, reinforcing their collaboration to bring Toraymyxin™ (PMX) to patients suffering from septic shock. The amended agreement ensures that Baxter will remain the exclusive distributor of PMX products for ten years following U.S. FDA approval. This partnership aims to address the critical unmet need in treating septic shock, a severe condition affecting approximately 330,000 patients annually in North America. PMX is a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream, guided by Spectral's Endotoxin Activity Assay (EAA™), the only FDA-cleared diagnostic for sepsis risk.
Strategic Partnership for Commercialization
According to Chris Seto, CEO of Spectral Medical, the extension of Baxter's commitment provides confidence in the commercialization path for PMX. "Baxter's continued commitment to Spectral as our exclusive supply and distribution partner being extended for a ten-year period upon U.S. FDA approval provides us with great confidence in our commercialization path," said Seto. This collaboration leverages Baxter's expertise in acute therapies and its established presence in intensive care units (ICUs) across the United States.
Gavin Campbell, President of Acute Therapies at Baxter, emphasized the strategic importance of advanced blood filtration therapies like PMX. "We are encouraged by Spectral’s evidence generation strategy for PMX, and our teams are fully engaged in support of our shared goal: reaching more critically ill patients with clinically effective and differentiated therapies," Campbell stated.
Tigris Trial and Milestone Payment
The amended agreement included a milestone payment from Baxter to Spectral upon reaching 90 patients enrolled in Spectral’s PMX-focused Tigris Trial. Spectral achieved this milestone on February 15, 2024, triggering Baxter's option to maintain exclusive distribution rights. The Tigris Trial is a confirmatory study evaluating PMX in addition to standard care versus standard care alone, designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. The trial aims to demonstrate the efficacy of PMX in treating endotoxic septic shock, a severe form of sepsis associated with significant impact on patient outcomes and healthcare costs.
About PMX and Endotoxic Septic Shock
PMX is already approved for therapeutic use in Japan and Europe, where it has been used safely and effectively on over 340,000 patients. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock. Endotoxic septic shock represents a critical area of unmet medical need, characterized by a dysregulated immune response to infection leading to organ dysfunction and high mortality rates. PMX targets the removal of endotoxins, key mediators of this inflammatory response, offering a potential therapeutic avenue to improve patient outcomes.
