If you were in Takeda's shoes.. Will you start completely new adventure in the search for a potential new product, wait for multiyears of research, and multi million dollars of new investments that might not lead anywhere..? or will you spend some few millions to get O back for immediate revenue generation..
the answer is.....
Let me remind everyone that a search for a magic explanation of O deaths is not merely 1.5 years old. No, it is closer to 4 years old. I will state again very truthfully that of the four original phase III trials, two of them were for non-dialysis patients. Those two studies showed O-related deaths.
Naturally, T&A wanted O to be approved for this (larger and more lucrative) population. They also had no way of knowing that FDA would (tragically) accept O on any level, given the O-related deaths. Therefore, T&A frantically attempted to determine the 'root cause' of the O-deaths approximately four years ago. That effort was not successful. Any reasonable person must conclude that O itself is by its very nature a Killer Drug which can't be explained away or 'fixed'. Thank you as always for reading and understanding the truth.
Bearing in mind the Actos $6Billion puntive damage award against Takeda, the answer is a resounding NO. In fact, Takeda has decided not to pay the monies necessary to protect the Omontys patents. Does Omontys sound like a blockbuster ESA compared to industry standard medicines such as Amgen's Epogen/Procrit and Roche's Mircera (dosed once every 4 weeks) with proven safety profiles? All of the other ESAs are approved for anemia in all patients, not just the to the sicker CKD dialysis patients that the FDA limits Omontys. Why is that? Paradoxically, the Omontys clinical studies (open label) showed that Omontys was unsafe to treat anemia for chronic kidney disease patients generally, but was safe to administer to the sicker chronic kidney disease patients who were on dialysis. Doesn't make any logical sense does it? AFFY and the FDA agreed that those paradoxical safety findings were "inexplicable" and for which "there was no definitive answer." Are there better biotech investments available? You be the judge. But for me, AFFY has little alternative but to go bankrupt. Failed drug. Proven alternative ESAs. No remaining business other than winding up affairs. Shell corporation. Little cash. Massive litigation. Insider selling. Time running out.
A blatant falsehood which is par for the course for AFFY longs. Here is a truthful excerpt from a Seeking Alpha article that reported on the FDA adverse event data base:
"The data shows there have been 22 deaths in which Omontys was reported to be the most likely cause of death! Furthermore, the report shows there has been at least one death (multiple additional cases of adverse events) reported as a result of subcutaneous administration of Omontys. Ex-CEO, John Orwin previously said "there have been no reports of such reactions …in patients receiving the drugs subcutaneously-although the subcutaneous patient numbers are limited". A key underpinning of the AFFY bull case was that the drug could be reintroduced under a limited subcutaneous-only label. That optimism appears misplaced now given a subcutaneous death. The FDA data presented here renders Orwin's statement patently false. We believe it is extremely unlikely that the FDA approves an interim reintroduction of Omontys under a subcutaneous label."