You can buy a twin-pack of Omega 3 fish oil at Walmart for six bucks. Yet Amarin ($AMRN) has been so certain that its prescription fish oil will have huge demand that it has spent the last 18 months getting manufacturing supply lines set up and discussing partnerships to make and sell it. Analysts are predicting huge sales and possibly a buyout offer. Analysts are already buzzing about that.
Now we get to find out if they are correct.
The FDA late Thursday gave approval of what Amarin calls Vascepa, a drug that can be used--along with exercise--to fight high levels of blood fat that can lead to stroke and heart attack. While the drug will come up against GlaxoSmithKline's ($GSK) Lovaza, it doesn't have the possible side effect of elevating levels of bad cholesterol.
It was disappointed to learn the FDA didn't give it the labeling it had hoped, limiting the pool of possible users, but expectations remain high.
The company says it expects to begin selling the drug in the first quarter of next year, but it has been preparing for that for over a year. After positive data from two late-stage studies set the stage for approval, the company got supply agreements in hand in preparing for an aggressive marketing campaign for the treatment. It signed deals with two active pharmaceutical ingredients makers and a couple of encapsulators. All with good reason.
This is Amarin's first approved product, but with the right partner to market it, Citi Investment Research forecasts the drug could reach peak sales of $2.6 billion. That would put it ahead of GSK's Lovaza and Abbott's ($ABT) Tricor and Trilipix. That is, of course, if it doesn't get a buyout offer that suits its mood. Analysts are suggesting AstraZeneca ($AZN) or Pfizer ($PFE) might be interested.
Even without a partner, analysts think Vascepa could generate $1.5 billion a year for Amarin, 50% more than sales of Lovaza.
The excitement stems from its clinical trial where Vascepa lowered triglyceride levels by 33% compared to a placebo in patients with baseline levels greater than 500 mg/dl. Shares of Amarin were halted ahead of the announcement at $15.31.
- here's the press release
- Bloomberg's take