Amarin: Prepping for FDA Approval Decision

BEDMINSTER, NJ ( TheStreet) --An Amarin ( AMRN) primer ahead of Thursday's expected FDA approval decision for the company's prescription fish-oil pill AMR101:

What time will the FDA decision be announced?

Impossible to say. We may hear in the middle of the day, like we did Friday with Onyx Pharmaceuticals ( ONXX), or not until evening as with Vivus ( VVUS). If you're trading the Amarin approval decision, my best advice is to be ready for news any time after noon EDT. And don't forget that Amarin may decide to halt trading at some point Thursday ahead of the announcement.

Is there a web site I can follow to read about the FDA decision in real time?

The FDA updates its web site with new drug approvals but generally not in real time. Same with FDA's online press room.

Amarin will issue a press release, of course, but I'll be shocked if the company is first out of the gate with the AMR101 news (unless the drug is rejected, which isn't likely.)

Your best bet for instantaneous reporting of the AMR101 decision is Twitter. Log into StockTwits and follow the $AMRN feed. If/when there's real news on AMR101, you'll see it on StockTwits instantaneously. I have a pretty good track record of having a fast draw with FDA drug approval news, so you can follow me on Twitter as well at @adamfeuerstein.

What's the chance that FDA will reject AMR101?

Tiny. I'd give it single-digit odds, certainly no more than that. Investors expect AMR101's approval Thursday by a wide margin -- and rightly so. If FDA rejects AMR101, the outstanding issues are likely to be relatively easy to fix.

Will FDA announce AMR101's New Chemical Entity (NCE) status simultaneously with approval?

Not necessarily. FDA may not make the AMR101 NCE decision public until the Electronic Orange Book (EOB) is next updated, which means Aug. 10.

Amarin has stated previously, however, that FDA may announce its approval decision and NCE status simultaneously. We'll know Thursday.

AMR101? I thought Amarin changed the drug's name to Vascepa?

If we believe the marketing web site leaked Friday, AMR101's new brand name will be Vascepa. Note that Amarin has also trademarked some other possible names, too, including Amracor and Civapri. I'll start referring to AMR101 as Vascepa.

Arena Pharmaceuticals (ARNA) and Vivus have both traded lower since their respective drug approvals. Is this what we can also expect from Amarin?

The recent trading pattern for FDA drug approvals (see Arena, Vivus) has been a short-term price spike followed fairly quickly by significant selling/profit taking. With expectations for Vascepa approval so high already, what's preventing Amarin from acting just like Arena and Vivus did?

Here's my prediction (which is probably not worth the electronic ink used to print it): Amarin shares trade up to $18-20 on approval with NCE status still undisclosed but then sell off as investors start wondering about Vascepa's launch. There's more upside in the stock -- and durable -- if approval and NCE status (five years' exclusivity) are granted Thursday, even more if Amarin announces a boffo partnership or takeout in conjunction with Vascepa's approval. Maybe that Pfizer ( PFE) partnership/takeover rumor is true?!?!?

If Vascepa is approved but FDA denies NCE status, Amarin shares fall below $15 (how about $12-13?) unless the company props up the stock with a boffo partnership or takeout.

Why can't Amarin sell Vascepa on its own and retain all the drug's profits?

Amarin could do that but Wall Street won't be happy about it. Let's face it, investors want Amarin to be sold soon after Vascepa's approval. Amarin's stock price sinks the moment CEO Joe Zakrzewski starts talking about launching Vascepa solo. Investors may not even be happy if Amarin decides to remain independent but sell Vascepa though a Big Pharma partner (like Pfizer!) even though the company could still do very well under this scenario.

Aside from the approval (expected) and granting of NCE status (hoped for), what else should investors be looking for from the Vascepa announcement Thursday?

Watch to see if FDA approves Vascepa with a broader label that includes reductions in triglycerides (TG) and apolipoprotein B (ApoB), the substance that carries LDL (bad) cholesterol throughout the body. An indication for ApoB lowering would differentiate Vascepa further from GlaxoSmithKline's ( GSK) Lovaza, which is only approved for TG reduction. This broader label would also further strengthen Amarin's patent position.

Another possible upside: Inclusion in the Vascepa label of data from the phase III "Anchor" study in patients with high TGs (as opposed to a label that only includes data in patients with very high TG levels from the "Marine" study.)

Amarin already plans to seek an expanded label for Vascepa to cover the larger patient population indicated by the Anchor study data. But if these Anchor data (TG reductions and no reductions or even decreases in LDL) are mentioned in the initial label, doctors may be more willing to prescribe the drug to a broader patient population immediately.

How big of a drug can Vascepa be if you include only the very high TG patient population from the Marine study?

Here's the simplest way of thinking about Vascepa's commercial potential: Glaxo's Lovaza generates sales of around $1 billion annually derived from single-digit market share among the 3.8 million people with very high trigylceride levels. Lovaza is not prescribed to the 36 million people with high triglyceride levels. Vascepa is superior to Lovaza.

Vascepa peak sales have the potential to be two, three or even four times that of Lovaza if Amarin or its partner/acquirer can grow the market for prescription fish oil. Positive results from the ongoing cardiovascular outcomes study would be a huge growth driver, and of course, the company must fend off generic competition for as long as possible, hopefully through 2030.

--Written by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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