Baxter, Spectral Medical Reach Agreement for Blood Filter Distribution

Baxter International Inc., a global medical products company, and Spectral Medical Inc., a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, have announced a distribution agreement for TORAYMYXIN PMX-20R (PMX), a hemoperfusion filter, and the Endotoxin Activity Assay (EAA), an on-market companion diagnostic tool that aids in the risk assessment of ICU patients for progression to severe sepsis. PMX is an investigational device in the United States that removes endotoxin, which contributes to sepsis, from the bloodstream.
 
As part of the agreement, Baxter has agreed to pay Spectral a series of milestone payments including a $5 million upfront rights payment. Baxter will be Spectral’s exclusive distributor of the PMX filter in the United States and Canada and has non-exclusive rights to distribute the EAA globally. Spectral will receive access to Baxter’s market capabilities while retaining control over the PMX regulatory approval process. Baxter has the option to maintain exclusive rights for PMX through future milestone payments and maintaining certain performance obligations.
 
”Spectral believes that Baxter is the best industry partner to commercialize the PMX product within the U.S. and Canada,” said Dr. Paul Walker, CEO of Spectral. “This agreement provides Spectral access to Baxter’s large installed base of critical care devices in hospitals across the U.S. and Canada, and Spectral believes this partnership significantly accelerates the company’s commercialization efforts for PMX.”
 
“This agreement provides an opportunity to broaden our portfolio and expand Baxter’s offering in sepsis management,” said Reaz Rasul, general manager, Baxter’s Acute Therapies business. “We are partnering with Spectral to advance purposeful innovation to help clinicians address a serious issue in critical care.”
 
Recruiting for Spectral’s Tigris clinical trial for PMX is underway in the United States, and the trial is expected to be completed in late 2021. Tigris is a follow-on study that builds on knowledge gained from the EUPHRATES trial, a large prospective randomized blinded trial performed in North America and completed in 2018. Tigris is a prospective randomized, open labelled trial of 150 patients with a two-to-one randomization favoring the treatment arm. The end point remains a reduction in the 28-day mortality using the PMX filter versus the standard of care.
 
The EAA, which is the only commercially available, U.S. Food and Drug Administration (FDA)-cleared test to measure endotoxin activity in whole blood, is a semi-quantitative test for the measurement of endotoxin activity and allows for rapid measurements to obtain results in approximately 30 minutes. While Spectral’s EAA is currently cleared by the FDA, Baxter plans to commercialize the EAA and PMX filter together following successful completion of the Tigris trial and subsequent FDA approval. Baxter plans to market the diagnostic tool in some countries in Europe, where the EAA is currently CE marked, alongside the company’s Oxiris blood purification set.
 
Oxiris is a three-in-one set for continuous renal replacement therapy (CRRT)-sepsis management to help simplify multiple treatment challenges for critically ill patients. The Oxiris set is designed to combine three functionalities in a single device: endotoxin removal, cytokine removal, and fluid/uremic toxin removal. Oxiris is not approved for use in the United States.
 
The Impact of Sepsis and the Role of Endotoxin
Globally, a recent study estimated that 48.9 million incident cases of sepsis were recorded in 2017, resulting in 11 million sepsis-related deaths.¹ In the United States alone, sepsis has a high cost of hospitalization consuming more than $27 billion per year² with an estimated 1.5 to 2 million new cases diagnosed each year.³ Septic shock, the most severe form of sepsis, is predominantly treated in the ICU.
 
The use of blood purification filters to remove cytokines and endotoxin from the blood represents a promising approach to treat patients with conditions where excessive levels of those inflammatory mediators are often seen, including sepsis. Additional research is ongoing to understand the potential of blood purification to help address sepsis and other conditions.
 
The Oxiris set is indicated for use only with the Prismaflex control unit or with the PrisMax control unit (in countries where PRISMAX is cleared or registered). It is intended for patients in need of blood purification, including continuous renal replacement therapy, and in conditions where excessive endotoxin and inflammatory mediator levels exist.
 
References
¹ Rudd, Kristina E., et al. Global, regional, and national sepsis incidence and mortality, 1990–2017: analysis for the Global Burden of Disease Study. Lancet 2020; 395: 200–11
² AHRQ, 2014
³ JAMA Netw Open. 2019;2(2):e187571. doi:10.1001/jamanetworkopen.2018.7571