I asked CEO Joe Zakrzewski why his stock traded like crap (I did use the word "crap") if the commercial potential for AMR101 was in the multi-billions of dollars as he discussed during his presentation. Seriously, Amarin trades like the AMR101 phase III trials failed.I didn't expect Zakrzewski to respond by confessing any mortal sins. He blamed the weak overall market. He said "rightly or wrongly" investors expected a partnership or takeout too soon. [He said nothing about his previous comments that definitely help set those expectations.] He called the drops in Amarin's stock price based on the early rejections of the AMR101 patents as "much ado about nothing." I'm glad I asked the question. Zakrzewski handled it as best as he possibly could given the situation. He's right about AMR101's blockbuster commercial potential and the really great data from the Marine and Anchor phase III studies. FDA has not said anything to Amarin about changing its mind regarding the initial approvability of AMR101 based on the Marine data in very high triglyceride patients. Specifically, the FDA has not said anything about requiring outcomes data in order to approve AMR101 based on Marine. On New Chemical Entity (NCE) status, Zakrzewski said Amarin fundamentally believes that AMR101 is a different drug than Lovaza and the other medicinal fish oils currently on the market, mainly due to its purity. He also made this good point: "To my knowledge, an outcomes study has never being requested for a drug that didn't get NCE status." If FDA wasn't prepared to provide Amarin with the eight or so years of market exclusivity that comes with NCE status, would the agency really demand the conduct of an 8,000-patient cardiovascular outcomes study that will cost $120 million? It doesn't make sense to me. Zakrzewski also stressed that FDA has never indicated or threatened Amarin with withholding or denial of NCE status for AMR101. A September 2010 story in a local newspaper reported that Amarin's congressman, Rep. Joe Courtney, was asked for help to smooth over AMR101's NCE status with FDA. Courtney asked Amarin, generally, what he could do to help the company, Zakrzewksi said. Amarin didn't specifically ask the congressman to lobby FDA regarding AMR101's NCE status because FDA hadn't raised any issue or concern with NCE status, Zakrzrewski said. Zakrzewski didn't say anything new regarding AMR101 patents. He stressed, as he has done in the past, that Amarin is filing dozens of new patent applications based on the Marine and Anchor data. He's hopeful about getting some patent acceptances or approval this year based on an accelerated filing program. All in, I do feel better about Amarin after hearing Zakrzrewski offer his spiel at the conference today. More importantly, will investors here who heard him speak or meet with him over the next four days start buying Amarin's stock? Let's hope so. P.S. One question I thought about asking Zakrzewski but decided to shut up because someone would smack me: "Are you now in active negotiations with potential partners or buyers?" --Written by Adam Feuerstein in San Francisco.
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