received good news Thursday night --
FDA approval of its prescription fish-oil pill Vascepa
. The news prompted Ken M. to ask, "Thanks for the Amarin scoop… Any advice for the near future (like as near as today) on that stock would be welcome here."
Vascepa's approval is obviously a nice win for Amarin but also expected and the easiest of the three major hurdles facing the company. [The other two being the decision on New Chemical Entity status and Vascepa's commercialization strategy - both still unknown.]
My quick take on the Vascepa approval and label: Strong. In particular, the FDA allowed Amarin to include data and language in the label that describes LDL neutrality, meaning no increases in "bad" cholesterol, as well as reductions in ApoB. Both these benefits differentiate Vascepa from
Lovaza in a good way and help Amarin strengthen the patent estate around the drug.
What's missing from the label? Not much. No mention of the "Anchor" data in high triglyceride patients but inclusion would have been a surprise gift from FDA. Amarin will still move forward with plans to expand Vascepa's label through an expanded approval.
What's left to do and worry about? First on the list is the length of Vascepa's market exclusivity -- five years or three years -- via a decision on New Chemical Entity (NCE) status. It would have been nice had this decision been made and announced Thursday night but Amarin said (not unexpectedly) that NCE status would be announced in the middle of next month when FDA updates the Electronic Orange Book.
Sell-side analysts who cover Amarin have been de-emphasizing the importance of NCE status in relation to the growing strength of Vascepa's patent portfolio. That’s true to some extent but I still believe gaining NCE status and the five-year market exclusivity is significant for the drug and the stock because it keeps generic competitors at bay longer. Without NCE status, generic drug company will be able to file paragraph IV challenges to Vascepa's patents on an accelerated basis. Amarin will fight generics in court, obviously, but that overhang and uncertainty will weigh on the company's stock price, in my opinion.
Lastly, Amarin hasn't told investors how Vascepa will be marketed. All three options disclosed previously -- selling the company, partnering with a large pharmaceutical company or selling the drug on its own -- are still being considered, Amarin said.