Already suffering from an expert panel rejection for an expanded label on its cholesterol drug Vascepa, Amarin was subjected to another drubbing on Wall Street after the FDA formally withdrew its Special Protocol Assessment agreement on a study of the treatment.
Shares of Amarin were blasted this morning--plunging 63%--as investors got a chance to vote with their money on the company's prospects following a decisive failure to persuade an FDA advisory committee that its fish-oil pill Vascepa should be approved for a much wider audience.
An FDA advisory panel is against extending the use of Amarin's fish-oil drug Vascepa with a cholesterol-lowering statin to reduce the risk of coronary disease; they are not convinced that doing so will prevent users from getting the potentially fatal disease.
So what is the difference between a drug approved to treat very high triglycerides and one approved to treat merely high triglycerides? Thirty-six million more potential patients, and, in the case of Amarin's Vascepa, maybe the results of a clinical trial on heart risks.
Poor Amarin and its still unrealized hopes for its fish oil cholesterol pill, Vascepa. A U.S. appeals court has paved the way for generic versions of blockbuster Lovaza, which GlaxoSmithKline and Pronova BioPharma sell, but the news undercut the much smaller Amarin, which has been trying hard to get traction for its own omega-3 drug.
Irish drugmaker Amarin continues to stack up manufacturing partners for the API for its fish oil drug Vascepa. While its decision to launch the drug without a partner has meant slow going in getting it to market, Amarin has pushed ahead with deals with contract manufacturers, hoping to get FDA approval for a fourth API maker.
Amarin, which has been setting up a global network of contractors for manufacturing its fish oil product Vascepa so it is ready to go when it starts its hard push for the heart drug, has forged two more links in the chain of manufacturing facilities.
Let's face it: When it comes to new drug approvals, projected blockbuster revenue is one of the sexiest aspects of the story. So when Biogen Idec's new Tecfidera was approved for multiple sclerosis, the main competition was seen in bidding up what the drug is likely to bring in for the Boston-based biotech. And the numbers soared to full mega-blockbuster status.
Omthera Pharmaceuticals is heading to Wall Street in search of $75 million of IPO cash to support a prospective launch of an omega-3 drug, soon after the biotech reported positive Phase III data and laid out plans to file for an approval within months.
The future of Amarin ($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.