CytoSorbents Corporation (CTSO)

[techxen]

Exciting development: Alexion agrees to buy Portola Pharmaceuticals

I know this is lengthy but after you read it you will see the direct implications for CTSO with regards to the opportunity here in the U.S. for the reversal of blood thinners.

News today, drugmaker Alexion Pharmaceuticals Inc agreed to buy Portola Pharmaceuticals Inc in a deal that values its smaller rival at $1.41 billion to gain access to a treatment for reversing the effects of blood thinners.
Alexion will pay $18 per Portola share in cash, a premium of 132% to Portola's last closing price, the companies said. Portola's shares have fallen 68% in 2020 through Monday's close. The treatment, Andexxa, was approved in the United States in 2018 and had brought in sales of $111.5 million in 2019.

https://finance.yahoo.com/news/alexion-buy-portola-pharmaceuticals-1-114942814.html

Andexxa, which is a factor Xa inhibitor, reverses the effects of uncontrolled bleeding caused by the popular blood thinner drugs, Xarelto and Eliquis. Despite the fact that this blood thinner reversal agent is the only known “antidote” to bleeding caused by Xarelto and Eliquis, and despite the fact that it has been shown to be safe and effective, many hospitals are refusing to carry Andexxa because “the price is too high.” The result is that people are still dying of uncontrolled bleeding — unnecessarily.

I did some research on the prices and the treatment with the high-dose costs $49,500 for the drug alone! The low-dose costs half as much. While the Andexxa cost may seem high, it pales in comparison to the cost of caring for severe life-threatening bleeds in the hospital, which exceeds $100,000. Reimbursement coverage reduces the cost burden further. The MS-DRG payment covers up to 50% of the cost, while the New Technology Add-on Payment (NTAP) allows up to $14,062 ($15k per dose).

Andexxa received FDA Accelerated Approval back on May 3, 2018. Initially, 40 stroke centers and acute treatment facilities were included in the early pilot program to assess the drug’s real-world results. The U.S. Food and Drug Administration granted full Andexxa approval on December 31, 2018. Andexxa has not been approved for Savaysa (edoxaban) or Bevyxxa (betrixaban) – for which there are no specific FDA-approved antidotes.

Now here is the direct impact on CTSO - taken from past transcripts and comments from Dr. Chan:

"CytoSorb has been demonstrated to be able to remove not just ticagrelor (Brilinta), which is one of the P2Y12 platelet inhibitors, but has also been demonstrated to be able to remove both rivaroxaban (Xarelto) and an apixaban (Eliquis). For Xarelto it has currently about $6 billion in worldwide sales. And then also Eliquis, which has about 10 billion in worldwide sales. Xarelto and Eliquisare in the class of antibiotics called factor 10A inhibitors.

So currently the only factor 10A inhibitor reversal agent on the market is Portola's Andexxa and we are - based upon the data that they presented, the reasons why our therapy would be a better reversal agent for cardiac surgery patients given that the reversal agent only is effective during the time of infusion. It also has a blackbox warning of being pro thrombotic, which is negative in patients undergoing cardiac surgery and also is a very expensive drug."

"For the Factor Xa inhbitors, Andexxa by Portola Pharma is the reversal agent. But dig deeper. It only works during the 2 hour infusion and then the effect wears off, it has a black box warning as being pro-coagulant (which you do not want in someone who just had a heart attack from a clot and has a new bypass grafts) and costs > $15K per dose. For GI bleeds, intracranial bleeds/strokes, and trauma, Andexxa is a good option. For cardiac surgery, CytoSorb is a much better option, IMO."