BEDMINSTER, NJ (
included some interesting new language in an
8-K filed Wednesday
regarding Vascepa and the long-delayed FDA decision on New Chemical Entity (NCE) status:
"While Amarin continues to believe its arguments in support of an NCE determination for Vascepa are strong, the FDA may not agree with Amarin's arguments."
Vascepa was approved in late July and yet there's still no FDA decision on the much-needed five years of market exclusivity that comes with NCE designation. [For those keeping score at home, we're on NCE decision delay No. 4.]
What's different this time, however, is that Amarin appears to be finally acknowledging the big risk:
FDA isn't convinced Vascepa deserves NCE designation
because the active ingredient in the prescription fish-oil pill is too similar to
(GSK - Get Report)
The previous two Amarin 8-Ks dealing with Vascepa NCE decision delays did not include the above-mentioned sentence.
Amarin has warned investors about the risks related to Vascepa and NCE designation in previous quarterly SEC filings using the following language:
"We cannot assure you that FDA will make this determination in a timely manner, or that we will be granted NCE exclusivity."
There's a subtle difference but significant.
Amarin also states in Wednesday's 8K:
"As previously disclosed, Amarin continues to anticipate commercial launch of Vascepa in the first quarter of 2013, and continues to consider three potential paths for the marketing and sale of the product: an acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third-party support. As previously disclosed, Amarin is now focused on continued commercial preparations for Vascepa which includes, but is not limited to, finalizing the introduction of Vascepa to managed care plans to gain formulary access, building up inventory levels, hiring key personnel and coordinating other pre-launch marketing activities."
The likelihood that Amarin launches Vascepa on its own grows as the NCE decision delay continues. Amarin bulls continue to insist that NCE status is irrelevant and that a takeover at a big premium is in the works.
Amarin shares are down 8% to $10.89 in Wednesday trading, which means the stock has lost almost 30% of its value since Vascepa was approved. I'd say the market doesn't agree with the Amarin bull story.
-- Reported by Adam Feuerstein in Boston.