Biotech firm Amarin Corp. said Thursday it is putting off a final decision on whether to market heart drug Vascepa without the muscle of a major partner, an announcement that has Wall Street buzzing about why, more than four months after receiving regulatory approval, the company still hasn't hooked up with a heavyweight pharmaceutical marketer.
Amarin's chief executive Joseph Zakrzewski, in a conference call last month, had said the company with R&D headquarters in Groton expected to make a final decision on whether to self-commercialize Vascepa in November. But now the biotech, in a regulatory filing, says it doesn't plan to finalize whether to hire its own sales representatives until sometime in the first half of December.
"Most companies are champing at the bit to start selling within days or a few weeks of approval," said Adam Feuerstein, a blogger for thestreet.com. "Not Amarin, which which apparently believes Vascepa needs aging, like fine red wine, before it hits the market."
Rumors about a possible marketing partner or a buyout of Amarin by such major pharmaceutical companies as Pfizer Inc. and AstraZeneca had been propping up the stock in recent days, and Citigroup initiated coverage of the stock this week with a price target of $20. Thursday's announcement did nothing to hurt the stock price, which was up 11 cents to $11.99 a share by the end of trading on the Nasdaq exchange.
Feuerstein noted that some traders have apparently interpreted the delays as a positive sign that negotiations are still under way and that a deal must be near. He also noted that the company has been hurt by U.S. Food and Drug Administration indecision on whether to grant the fish-oil drug Vascepa the status as a new chemical entity, which would extend the life of Amarin's patent protection and would make the firm more attractive as a buyout.
But David Williamson, a healthcare analyst for the personal-investing website TheMotleyFool.com, said the FDA likely would have rejected the new-chemical status for Vascepa weeks ago if it had any major reservations about the drug. The agency is scheduled to release another series of rulings on various drugs, possibly including Vascepa, Dec. 14, which corresponds closely to Amarin's decision timeline on marketing its own product.
"Vascepa should be a blockbuster regardless," Williamson said in a video posted on the website. "Vascepa could target as much as one third of the U.S. adult population."
Feuerstein wasn't so sure, saying that the company could have negotiated a deal contingent on FDA acceptance of Vascepa as a new chemical entity.
"If Vascepa is the billion-dollar generating blockbuster drug the company and its supporters claim, why hasn't a Big Pharma partner already gobbled up marketing rights?" Feuerstein wrote. "Does fish oil smell any better if it sits around for four months?"