I think I might have figured out why Watson filed the appeal. It was likely a condition of the sale to Teva. The sale was in process before the Judges ruling and Watson had the first mover generic as part of the deal. The conditions changed so Watson filed the appeal to hopefully attain the original conditions. Although futile, the act of filing probably satisfied some legal provision.
Nice to see you Dendreonpro. I'm thinking this Teva action is designed to negate NCE? Wouldn't Amarin have to defend if Teva was allowed to appeal? Any comments?
So AMRN won the NCE ruling and the FDA didn't appeal but Allergan's Watson did, but they announced Watson and Allergan's entire generic holdings were sold to Teva. So we're waiting to see if a Judge will allow a company to take the place of the FDA to fight AMRN in court over exclusivity, so that Teva which has a tremendous conflict of interest to get their generic version some traction. The first amendment case is on deck waiting for that Judge to rule on a preliminary injunction so that Amarin can say things about a trial the FDA approved. In the meantime the FDA after the fact, after oral arguments, the FDA decided to tell the court they have no subject matter jurisdiction and the tomato ain't ripe. At the same time V sales continue to grow but now under threat by the HHS OIG watching for unlawful off label conspiracies.
I thought Engelmayer's comments during oral arguments were similar to Moss'. Telling both sides the arguments were terrific indicates searching for some middle ground. Any language allowed is some kind of victory. I'm not concerned with Watson anymore. Only an act of god could make that appeal happen. Some dominos are about to fall. Thanks for your post. Onward to Reduce-It.
Many have conjectured this and that about the merits of Amarin's victory in getting NCE. Adam Feuerstein, bless his little shriveled up heart, said it was too late to do any good. WOW, thanks Adam, shut up. It certainly helps Amarin avoid any patent fights for quite a while, so I think it does a lot of good. Now, if Amarin wins the first amendment case, even if it's not everything they asked for, it represents a 2nd consecutive victory over the FDA. ARE THERE ANY OTHER COMPANIES THAT ARE 2-0 AGAINST THE FDA? The victories are stunning and point to a pattern of abuse by the FDA ever since they decided to make ADCOM about CVE reduction, when clearly that wasn't the intention early on. The reason to award ANCHOR or to award any company some labeling expansion before longer term studies become available is the ability to pay for those studies. No other drug had anything close to a JELIS study to point to as an actual reason to believe CVE reduction would be the result. Only Amarin, and yet they're the only company punished with a drug that EXCEEDED EVERY PARAMETER sought by the FDA in ANCHOR with a safety profile similar to placebo. That kind of rejection has not happened in HISTORY. The continuous studies here and in Japan showing the anti-inflammatory impact of pure EPA have been "pondered" by the FDA and then summarily dismissed as "not enough evidence". Heck, they've got a drug just approved, Praulent, that already in very small studies shows cognitive impairment, maybe leading to Alzheimers or something else very bad in a very short time, they don't know. But they approved it because guess what, it improves a lipid parameter????? This is a clear pattern of abuse. I'm very surprised Praulent has been approved for a patient population 2.5 times the size of MARINE without knowing hardly anything about really obvious possible negative results. After winning the first amendment case, Amarin might just decide to keep on after the FDA with a criminal case.
There is a .0000001 % chance of Watson being allowed to appeal the FDA's lost case. The reason is this is the FDA's territory and nobody else. They rule on NCE or NME period. The court is this case is only an avenue for the party that was seeking exclusivity to sue the FDA, no one else. The FDA can come back and appeal, but to have another company step in and in effect do the FDA's job is beyond the pale. Still, a Judge could decide they have standing. If that happens, then I would say the fix is in and forces beyond the law have taken over, much as I feel some higher ups at the FDA did at ADCOM. Then Watson would likely win the appeal and be able to win the patent war over a company with barely the resources to survive funding Reduce-It. That's terrifying. On the other hand, the filing indicates a level of interest in Vascepa that suggests BP is figuring out they may have only this chance left to stop a juggernaut from arriving, with the Baker Bros to prevent any cheap tactic to buy for loose change. The next two weeks will be unbelievably good unless that .0000001 % chance occurs. The Watson case will be thrown out, the NCE will be awarded, Engelmayer will likely give Amarin some labeling relief and any frigging scientist with a darned brain can already tell Reduce-It is probably going to work, (that's why Watson wants it so bad they are trying this last ditch effort). That's exhilarating.
Akanz, awesome to hear from you. Things are pretty exciting. Praulent is incredible. Best to you.
No, but there is technically merit if someone in power reads the law a certain way. Much the same as the FDA denied the safest drug imaginable with a study that showed true promise. Their logic technically made sense, but it was a wretched thought process.
If Watson gets to argue against Amarin in an appeal, they will be assuming the role of the FDA. As such, they will be accorded the role and presumably the power of a government agency with personal financial motives to pervert the arguments. Oh well, it's Amarin, stomp away.
Agree. Watson would be stepping in to use substantial resources to gain benefit against a company that was harmed not only by the ruling of NME but also the 18 month FDA delay. Watson is indeed injured by the courts ruling, but only because of the FDA's mistake. To now allow Watson to punish Amarin in court is horrifying in precedent.
It has my attention for sure. Obviously this is unusual and I'm disgusted but fascinated too. I thought what the FDA did to AMRN via NCE, SPA, ADCOM, and ignoring all the science since then was bad enough. This would be our court system chipping in and butchering Amarin in an even more horrible way. I know a lot of observers are saying the Watson filing is ridiculous, but as an Amarin watcher, I wouldn't be surprised. Saddened beyond belief, but not surprised.
The FDA has deep pockets but they have to Marshall their resources to greatest effect. Allergan on the other hand can devote millions and millions to the NCE case and weaken Amarin along with winning the case then they can go after the patents. If the court allows this appeal, Amarin is done.
So we now have generic makers chiming in on the NCE decision. If the court takes this up that's a pretty indication the corruption goes higher. Well, I guess generic cheap Vascepa is a good thing. Amarin just got in the way. Thoroughly disgusting yet a learning moment.
Sales of Niaspan continued over a billion dollars in 2012 and 2013 with the failed Aim-High study to help the FDA keep labeling beneficial. Vascepa has a successful study that needs to be verified, JELIS, while running a $150 million study the FDA required for ANCHOR approval. I "get it" Jesse.