6 February 2020 - - US-based medical products company Baxter International Inc. (NYSE: BAX) and late stage theranostic company Spectral Medical Inc. (TSX: EDT) have inked a distribution agreement for Toraymyxin PMX-20R, a hemoperfusion filter, and the Endotoxin Activity Assay, an on-market companion diagnostic tool that aids in the risk assessment of ICU patients for progression to severe sepsis, the companies said.

PMX is an investigational device in the US 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 USD 5m upfront rights payment.

Baxter will be Spectral's exclusive distributor of the PMX filter in the US 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.

Recruiting for Spectral's Tigris clinical trial for PMX (www.clinicaltrials.gov: NCT03901807) is underway in the US, 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 randomised blinded trial performed in North America and completed in 2018.

Tigris is a prospective randomised, open labelled trial of 150 patients with a 2: 1 randomisation 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, 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 3-in-1 set for continuous renal replacement therapy -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.

Globally, a recent study estimated that 48.9m incident cases of sepsis were recorded in 2017, resulting in 11m sepsis-related deaths.

In the US alone, sepsis has a high cost of hospitalization consuming more than USD 27bn per year with an estimated 1.5 to 2m new cases diagnosed each year3. 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.

PMX is not approved for use in the United States.

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.

This set is intended for use in the following veno-venous therapies: SCUF; CVVH; CVVHD; CVVHDF.
All treatments administered with the Oxiris set must be prescribed by a physician.

It is contra-indicated to use the Oxiris set where patients present a known allergy to heparin or have type II thrombocytopenia caused by heparin (HIT Syndrome type II).

Spectral is a late stage theranostic company seeking US FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin.

PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the company's Endotoxin Activity Assay, the only FDA cleared diagnostic for the risk of developing sepsis.

PMX has been approved for therapeutic use in Japan and Europe, and has been used on more than 170,000 patients to date.

In March 2009, Spectral obtained the exclusive development and commercial rights in the US for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada.

Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new proprietary platform, "SAMI," targeting the renal replacement therapy market.

Dialco is also seeking regulatory approval for "DIMI" which is based on the same RRT platform, but will be intended for home hemodialysis use. Spectral is listed on the Toronto Stock Exchange under the symbol EDT.