Months of waiting anxiously for a key decision from the FDA on its newly-approved fish-oil therapy Vascepa has created an unsettling aroma of uncertainty over the future of Amarin ($AMRN). And it's spurring some dyspeptic reactions in the biotech investor community.
In biotech, a company's fate is usually fairly clearly mapped out by the time its first new drug approval lands. It will launch on its own, or already has a Big Pharma company lined up to do the heavy lifting of commercialization work. But Amarin isn't the typical biotech. It scored an FDA approval for the mass-market therapy on its own back in July, heightening lingering expectations that a big player would either swallow the company whole, strike a lucrative marketing partnership or the company would go it alone and hire a sales force. But the company has been forced to struggle in limbo as regulators ponder whether the treatment qualifies for new chemical entity status, a key determinant of just how long generic competition can be kept at bay. And instead of exciting investors, the waiting game has caused a steady leak in the company's share price, now down about 30% since the regulatory OK came through.
"Another delay today raises questions about whether Amarin will move forward with partnership and buyout discussions or continue to wait for an answer from FDA," Wedbush analyst Akiva Felt told The Wall Street Journal last Friday.
That's what TheStreet's Adam Feuerstein has been saying for months now, rarely missing a chance to shout out catcalls on Twitter as the delay turned from weeks into months. If the company is faced with continued delays and doesn't pull the trigger soon, he notes, Amarin is in danger of missing its early-2013 window for launching the drug, which would lead to more bloodletting on the stock price.
Amarin Chief Executive Joseph Zakrzewski has slowly opened up to the implications of the delay, telling investors recently that it would be hard to strike a deal without a final decision on the NCE status. And every Friday the agency's Orange Book doesn't resolve the issue, uncertainties will continue to confound the company.
Forbes, meanwhile, added insult to injury with a story from Matthew Herper raising some disturbing questions about Vascepa's market potential. Amarin's chief rival, GlaxoSmithKline's Lovaza, has seen declining sales as doubts grow in the medical community about the efficacy of the fish-oil approach.
The takeover rumors, meanwhile, have continued unabated. Israel's Calcalist reported last week that Teva ($TEVA) and AstraZeneca ($AZN) were leading contenders for a takeover. But as FierceBiotech noted recently, Amarin has long been a rumored takeover target, with a potential big product in house and little chance of doing it justice by selling it alone.
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