Amarin ($AMRN) spooked investors yesterday by disclosing the FDA's apparent reluctance to give its fish-oil drug Vascepa 5-year exclusivity. Approved in July to reduce blood fats known as triglycerides, the drug may not be unique enough to win the agency's designation as a new chemical entity (NCE).
Of course, exclusivity is key for branded drugmakers. Without it, copycats rush in and prices drop. So, Amarin's future is dependent on the FDA's decision. It figures it has three options going forward: Selling itself, finding a partner and launching Vascepa itself, possibly with help from a contractor or partner.
The company has been planning to launch Vascepa early next year, and according to the company's disclosure to the Securities and Exchange Commission, still plans to do so. "Amarin is now focused on continued commercial preparations for Vascepa," the company said in the filing (as quoted by The Street), including building inventory, introducing the drug to managed care plans, and hiring "key personnel."
But the FDA's decision may not go Amarin's way. "While Amarin continues to believe its arguments in support of an NCE determination for Vascepa are strong, the FDA may not agree," the company said in its filing. "Amarin can make no assurance that Vascepa will be granted NCE exclusivity, or that the FDA will make a determination in a timely manner."