The folks screaming at me now for being bearish about Amarin (you're not screaming Tom, I appreciate that) have short memories. As Tom notes, I was an early Amarin bull, writing about the blockbuster potential of AMR-101 (now Vascepa) as far back as May 2010. Amarin shares were worth about $2.50 back then. I was firmly in the Amarin bull camp through the release of the MARINE data the ANCHOR data and FDA approval. I also believed initially that FDA would grant Vascepa New Chemical Entity (NCE) status.
But I also know better than to be wed to a stock. When facts change, opinions should change. That's why I'm more bearish on Amarin now. The facts have changed. Delay after delay signals FDA isn't likely to grant NCE status to Vascepa. Amarin has not found a commercial partner for Vascepa, nor has the company been acquired (despite being shopped around for a long time). Amarin executives have sold significant chunks of stock at prices higher than where shares trade today.
Troubling signs, all, which is why I changed my mind about the stock. You and others might disagree with me. I respect that. Markets are made up of people with opposing views. I'm doing the best I can to be right about Amarin. My track record so far is pretty darn good. I hope that run will continue.
With regard to Vascepa's NCE status, on Thursday, the health care research firm Marwood Group issued a note to clients predicting FDA would deny Amarin's request. The report is detailed but here's the summary:Marwood believes that the FDA will determine that Vascepa is not an NCE because the active ingredient in Vascepa is also contained in Lovaza, and therefore has been already approved by the agency previously. We believe that Vascepa does qualify for three years of market exclusivity, based on the new clinical data that was part of the application. While the FDA has shown some latitude in the past in its definition of NCE status, we believe that Vascepa does not fall into a category that would qualify for NCE status. Previously FDA awarded NCE status to Lovenox (a low molecular weight heparin product), hyaluronidase products, pancreatic enzymes and Vyvanse, which were cases where some ambiguity existed regarding previous approval of the active moiety. In contrast the FDA did not award NCE status to conjugated estrogen products. We believe that the Vascepa decision more closely aligns with the conjugated estrogen example.
One more Amarin email, this one from Trez45, "What will you do if Amarin announces a buy out next month timed to its third-quarter conference call?" I will congratulate Amarin longs, assuming the acquisition price is at a significant premium to the company's recent $15-per-share high. I will admit my recent bearishness was overdone. I will also be incredibly surprised because I don't believe Amarin is going to announce a buyout on its third-quarter conference call. Amarin's third-quarter earnings release and call are important. Vascepa was approved in late July but the company has still not made public the drug's commercial launch plans. Amarin can't delay forever because investors are already growing impatient. If Amarin has a partner lined up to help launch Vascepa, then management needs to disclose. If not, then step up and admit that they're moving ahead on their own.