Amarin today tossed another deadline on the bonfire of management vanities, scrapping a self-imposed decision date on hiring a sales force for the recently approved Vascepa. The new deadline is mid-December, when it will get another shot at an FDA decision on new chemical entity status, which has gradually swelled into a major catalyst for the company.
Amarin ($AMRN) "continues to anticipate the launch of Vascepa early in the first quarter of 2013," the biotech confidently announced in an 8-K. But as the weeks have stretched into months of waiting for the NCE news, managing timelines is not one of Amarin's notable strengths right now.
It has grown increasingly clear that the FDA approval of Vascepa, a prescription-strength fish oil drug aimed at the masses of Americans facing an epidemic of cardiovascular disease, was just the first of three key events for the company. Without NCE status, the drug will face a seriously constricted period for exclusivity. Analysts have been pooh-poohing the notion that the company can make a go of this one alone, looking for a pharma player with deep pockets to push this treatment to blockbuster status. And as a result the company remains one of the most frequently cited takeover targets in the business.
But how do you decide an acquisition price without the NCE status resolved? After four months of twisting in the wind, unwilling to pull the trigger on a feeble solo launch, maybe it's time for the dealmakers to get creative on terms. As it stands, Vascepa may soon have to be added to our list of launch disasters.
- here's the 8-K
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