marin's November Rendezvous With A Stepmotherly FDA, And Other Headlines: The Good, Bad, And Ugly Of Biopharma
Oct. 14, 2019 1:39 PM ET|40 comments | About: Amarin Corporation plc (AMRN), Includes: AERI, ARDS, ARPO, HZNP
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Summary
Amarin, as we all know, has a November 14 AdCom. What some of us may not know is the history. Covered here.
Amarin has won each battle it has fought with the FDA and its other detractors, and we expect it to win this one resoundingly as well.
Horizon Pharma (phase 3 data), Aerie, and Aridis are some of the other stocks we have covered.
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The FDA has a history of stepmotherly behaviour with Amarin (NASDAQ:AMRN). We saw it between 2013 and 2015, when the FDA issued a CRL to Amarin when the company asked for a very reasonable label expansion - and the FDA took an entire year to even issue the CRL. The saga of those sordid years can be seen in the graph below:
SOURCE
In mid-2015, Amarin filed a suit against the FDA, and a few months later, the court ruled in favour of the company. While us investors were amazed at the spunk of this little company - and the stock did spike a little - the stock took a long time to really recover.
Then finally, last year, the unthinkable happened - the company had incontrovertible proof of how well Vascepa works in patients at cardiovascular risk. This came in the form of the results from the REDUCE-IT trial, which showed - despite its detractors - that Amarin is really worth the trust investors had put into it.
However, the latest gimmicks from the FDA shows us, first, that the regulatory agency is still trying to keep Vascepa down like it did before, but, two, that this is further evidence that Amarin must be really onto something huge, and hence the effort to hold it back.
The latest game that has been played by the FDA sounds eerily similar - a long period of silence, and then a sudden issuance of regulatory decision that is meaningless and harms the stock. Yes, Amarin had 5 million pages of sNDA material from 35,000 patient years of data - it was taking no chances with the FDA. However, surely the FDA didn't notice that only in late August? So, last time, the FDA declared its own SPA with the company null and void. This time, the FDA effectively made its own priority review agreement with Amarin inconsequential by holding back a decision on the advisory committee meeting until the last moment, then declaring one, and thus extending review time to almost what it would have been without the priority review. And all this despite having seen the REDUCE-IT data almost a year ago, giving it enough time to decide whether expert opinion - aka the AdCom - was required or not.
Sometimes one wonders about the games that are played below the radar of public visibility.
So, the current situation - as all Amarin investors know - is that the late September PDUFA date has been replaced by a November 14 AdCom, and then a PDUFA on December 28. Vascepa is already approved as an adjunct to diet to treat very high triglyceride levels, or adult patients with severe hypertriglyceridemia of ≥500 mg/dL, without raising LDL-C or bad cholesterol. The 2013 sNDA was for the next set of patients - those with persistently high triglyceride levels from 200 to 499 mg/dL who are already on statin therapy. The FDA did not approve this sNDA, although the courts determined that Vascepa can market its drug as such, which is not really an approval, but worth it for the drug to make additional millions in sales.
This time, the label expansion is for expanded use of Vascepa to "reduce major adverse cardiovascular events (MACE) in individuals with elevated triglyceride levels, well-controlled low-density lipoprotein (LDL-C, or "bad cholesterol"), and established cardiovascular disease or diabetes."
Now, the September date came through a priority review. Without it, Amarin's date would have been in January. So, this saves it merely a month - thank you very much, FDA.
However, the purpose of this little note - something some investors may not be aware of - is that Amarin has always been a handful for even the FDA. If last time's action is anything to go by, the current low price is a last opportunity of sorts to get in on this drug's success story whose current sales of $400mn is at least a tenth of its predicted sales.
Investors should always keep in mind the tremendously successful results from the REDUCE-IT study. I should keep a sticky note stuck on my work desk with the following words:
Source
Leading to the following table:
Meanwhile, Amarin continues winning every other battle - the big one, REDUCE-IT, the patent battles, the battle against all sorts of misinformation, and some of which I have covered earlier - and we expect it to do nothing less than that in its upcoming struggles with the FDA. Armed with the outstanding results from the REDUCE-IT study, we expect nothing less. January 2020 should bring us a nice little gift in the form of Amarin's stock price hitting the 30s. If it doesn't happen in January, because of some new twist to the FDA tale, be assured it will happen soon enough.
Thanks for reading. Before we end, we want to inform readers that we are in touch with Amarin to get an exclusive interview with CEO John Thero. The interview, if it works out, will be published here on Seeking Alpha shortly, after our subscribers have had a chance to look at it firs
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