The future of Amarin ($AMRN) and its fish oil product Vascepa got a little more slippery Thursday. The Irish company said it had obtained $100 million in private financing to move forward with the drug come what may.
It will hire up to 300 sales reps to prepare to launch the omega-3 product in the U.S. early next year. Then it will see whether it will find marriage, a marketing partner or go it alone with the drug, which the FDA approved in July but the company has not yet gotten off the ground. It was looking for the FDA to designate it a New Chemical Entity (NCE), which would give the company two more years of exclusivity, but the agency has delayed that decision several times and meanwhile Amarin's fortunes have been sinking.
In a conference call, CEO Joe Zakrzewski called the failure to get the NCE tag "much ado about nothing," The Street said. But investors were not pleased to hear the company is taking on $100 million in debt. Its shares were off 21% in after hours trading, The Street pointed out. Earlier rumors that Amarin was in the sights of several companies have also since cooled. Analysts had suggested that AstraZeneca ($AZN) or Pfizer ($PFE) might be interested.
This is Amarin's first approved product and with the right partner to market it, Citi Investment Research forecasts that the drug could reach peak sales of $2.6 billion. That would put it ahead of GlaxoSmithKline's ($GSK) Lovaza and Abbott's ($ABT) Tricor and Trilipix. 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 33% compared with a placebo in patients with baseline levels greater than 500 mg/dl. But things have yet to play out the way they were predicted.
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