CytoSorbents Corporation (CTSO)

[techxen]

Andexxa and Cytosorb parallels?

Because Cytosorb will be up against the primary competitor in this space right now which is Andexxa, you can look at the history of this drug from Portola for a glimpse of what might occur with CTSO in terms of approval and possible outside investment. Remember Andexxa is currently the only approved therapy for the reveral of factor Xa inhibitors Xarelto (rivaroxaban) and Eliquis (apixaban). Andexxa was first granted Orphan Drug and then Breakthrough Therapy designations and then later the FDA approved it under the Accelerated Approval pathway.

Some key events in Andexxa history

5/5/20 - Alexion acquires Portola

5/24/18 - Portola receives the remaining $100M royalty payment from HCR which was conditional upon approval

5/3/18 - FDA Accelerated Approval of Andexxa
https://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM606693.pdf

2/3/17 - Portola signs $150M royalty agreement with HCR (Healthcare Royalty Partners) - $50M paid upfront. This was for a mid-single-digit royalty based on worlwide sales of Andexxa.

12/19/16 - Portola receives $50M in unsecured loans from Bristol-Myers and Pfizer (the makers of Xarelto and Eliquis)for the continued development of Andexxa (the makers of Xarelto and Eliquis). Note: this shows you how anxious the drug manufacturers were to get Andexxa across the finish lines and approved while their drugs are still under patent.

Prior to this point, Portola had struggled getting Andexxa approved and received a CRL letter from the FDA in 2016 to address manufacturing issues.


Summary
I think there is a high probability that the company could attract a similar large royalty deal or strategic investment by an outside partner for the following reasons:

- Cytosorb has been approved in the EU to remove both Brilinta (ticagrelor) and Xarelto (rivaroxaban)

- Cytosorb has studies which show effective and safe removal also of Pradaxa (dabigatran) and Savaysa (edoxaban)

- Cytosorb has multiple competitive advantages over Andexxa namely safety and cost (Andexxa has a pre-thrombotic risk as a black box warning, and it's a very expensive drug. It is somewhere in the range of $15 to $20,000 for a single dose)

- Andexxa product sales have seen a 20%+ year-on-year increase due to bleeding events in the U.S. The Portola CEO noted that Xarelto and Eliquis patents expire in 2021 and 2023 respectively and was forecasting the sales of Andexxa to rise even further due to the increase in availability of the treatments. This is not unlike the comment Dr. Chan made during the Q4 2019 conference call when he referenced AstraZeneca's Brilinta (ticagrelor) coming off patent in the next year or so.

- The company has as its Chief Medical Officer a subject matter expert in the clinical development, usage, and complications of anti-coagulants and anti-thrombotics. He was instrumental in the approval of cangrelor, a P2Y12 receptor antagonist in the same anti-platelet class as ticagrelor, in both the U.S. and Europe. Based on comments Dr. Deliargyris comments made during the last conference call, he is convinced Cytosorb can be approved here in the U.S. and will have a significant adoption rate by cardiac surgeons.

As Dr. Deliargyris says "There is a very different clinical need that's being addressed with Andexxa versus CytoSorb. Andexxa is used after the occurrence of life threatening bleeding. Think of Andexxa as being the airbag, which is deployed after the accident. Think of CytoSorb as being the seat belt. CytoSorb will prevent any excess bleeding and therefore we will be using the standard approach to anyone who has the drugs circulating when they enter the operating room."