BEDMINSTER, NJ (
) --Here we go again.
disclosed yet another delay Thursday. This time, the company is putting off a decision on hiring a sales force to sell Vascepa until the first half of December. Amarin had promised an announcement by the end of November.
For those keeping score at home, FDA approved Amarin's triglyceride-lowering, prescription-grade fish oil pill 126 days ago. After all the time, effort and cost to get a drug approved, most companies are chomping at the bit to start selling within days or a few weeks of approval.
Not Amarin, which apparently believes Vascepa needs aging, like fine red wine, before it hits the market. Does fish oil smell any better if it sits around for four months?
Amarin bulls will disagree, of course. They believe the company is both a victim of FDA's stubbornness over the still-unresolved NCE (market exclusivity) issue, and sneaky smart because negotiations for a blockbuster buyout deal must be imminent, hence all the delays.
It's no coincidence a decision on Vascepa's commercial launch is being delayed until mid-December since that coincides with FDA's next-scheduled update of the Orange Book. Amarin is clearly hoping (praying) that FDA gives in and grants NCE status to Vascepa.
How this helps Amarin avoid the disastrous "go it alone" Vascepa launch isn't clear. 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?
We know the uncertainty around Vascepa's NCE status has hurt Amarin -- management acknowledged this on its last conference call -- but that shouldn't have stopped the company and an interested, motivated suitor from negotiating a deal with a contingent value right (CVR) tied to Vascepa's NCE status.
For example, Big Pharma X agrees to buy Amarin today for $15 per share. If Vascepa wins NCE status later, Big Pharma X will pay an additional $10 per share to Amarin shareholders.
We've seen CVR-incentivized deals used commonly in bio-pharma.
created a CVR tied to the cancer drug Abraxane when it acquired Abraxis BioScience.
and Genzyme negotiated a CVR as part of their buyout deal.
Amarin should be the poster child for a CVR-type acquisition yet so far, no deal has been announced. To me, that's telling, and not in a good way.
What we get instead from Amarin is delay after delay layered on top of more delays. I commend Amarin bulls for their patience and relentless optimism. I just don't share the sentiment.
-- Reported by Adam Feuerstein in Boston.