Amarin (NASDAQ:AMRN) was the proverbial belle of the ball this summer after its hypertriglyceridemia drug Vascepa got the green light from the FDA. Investors were initially optimistic about this drug's blockbuster potential, and a buyout seemed to be a foregone conclusion.
However, uncertainty relating to Vascepa's NCE status has weighed heavily on this stock in recent months. Shares have slumped more than 15% since the beginning of October, and this has to be a sign that investors are losing confidence in Vascepa's chances of getting this designation. However, after dropping almost 4.5% today, shares of Amarin are rebounding after hours.
Could the tide be turning for this fledgling drugmaker? What did management say in its Q3 earnings call this evening that might have calmed investor fears?
Here are the essential takeaways from Amarin's third quarter report:
To NCE or not to NCE ... that is the question
Vascepa's New Chemical Entity, or NCE status, has dominated headlines of late, and much of tonight's conference call revolved around this issue. Amarin expected the FDA to award Vascepa the NCE designation -- and the accompanying five years of marketing exclusivity -- back in August. We're now approaching the middle of November, and the FDA still has not made up its mind. So where does the company stand today?
Amarin's CEO Joseph Zakrzewski stated that, while having the NCE would be a welcomed result, the company is more focused on expanding Vascepa's patent protection. Whether the drug gets the full five years, or only the abbreviated three years of exclusivity, Amarin believes that intellectual property will still be the strongest long-term roadblock to generic competition.
In any case, it sounds like Amarin simply wants the FDA to make a decision so it can figure out which commercialization strategy to pursue.
Deal, or no deal?
There has also been mounting speculation that Amarin remains a buyout target, regardless of Vascepa's NCE status. In fact, after being asked point blank whether a recent article linking AstraZeneca (NASDAQ:AZN) to an Amarin buyout had any truth to it, Zakrzewski simply replied "no comment." Despite this coy answer, it suggests that AstraZeneca is indeed one of many companies discussing either a buyout or partnership with Amarin.
However, it's also possible that the company could market Vascepa on its own early in 2013. This could mean that GlaxoSmithKline's (NYSE:GSK) hypertriglyceridemia drug Lovaza will compete with Vascepa sooner rather than later.
While management was confident about Amarin's future, it looks like this company will be stuck in neutral until the FDA decides whether Vascepa qualifies for NCE or not.