Steve Rosenman's  Instablog

The erroneous coverage by various media outlets and Street.com slime-ball Adam Fuerstein attempts to relate a poorly designed Italian OTC fish oil study with outcomes for Omega-3 class Rx drugs. WRONG GUYS...

Let me ask a question. If you had a headache and intended to use Tylenol at the 500mg effective dose, but only took 50mg, would you expect your headache to go away? Let me be more blunt, as someone from Aegis Capital notes, do you value a fake Rolex the same as a real one?

The above sentiments should put to bed any concerns over this re-hashed Italian study relating to bottom of the barrel fish oil, but if not consider:

• Vascepa has shown a dose dependent benefit. Mr. Fuerstein, since you clearly cannot read clinical trial data properly, if at all, that means the more you take, the better it works, both on linear indication and up vertically into other areas of cardio events, as proven in Jelis study. 1,000 mg is not 4,000 mg. I believe everyone can agree on that.
• Next, the study did not use Vascepa. It did not even use Lovaza. Amarin has already proven through Marine and anchor, the chemical differences and method of action vs. standard OTC fish oil. It's simply not debatable if you look at the data.
• Vascepa does not have the same side effects profile of other fish oils, including OTC. These side effects do the opposite you want for overall cholesterol management in relation to preventing cardio events.
• The Italian study was barely fine for comparing OTC supplements at 1,000mg and common grades of fish oil; but completely irrelevant to relate to Rx for more than the reasons listed above, for one, IT DID NOT BREAK DOWN AND GO DOUBLE BLIND ON ANY ONE INDICATION, it grouped all potential events together with no segmentation on at-risk patients. Really...???try doing that in the U.S.

What a joke... if anything, it promotes people to not use OTC and switch to Rx as soon as possible.

5/8/2013, 11:35pm updated

Changing my 2013 view for Amarin price target from $28-32 to $34 by May 2014 as company is well positioned to achieve NCE from FDA, be given Anchor indication approval on or before December 20, 2013; latest intel suggests the company is in very late stage discussions with potential strategic partners/suitors on how to proceed with launching Anchor.

Additionally, Marine launch seems to be going as forecasted. I do not believe we have a VVUS situation here and management likely to confirm slow, but steady and positive trend on 5/9 investor conference call. There could be slight, non-material upside or downside to the expected revenues generated over the past 3 months from Marine, but the launch seems to be trending as any new small pharma company launch would-- slow to start, with increasing scripts.

I believe FDA has given important clues over the past 2 months of how NCE will be treated, the company may know "when". A possible update on the conference call, but more likely this front will remain quiet, in the best interest of AMRN-FDA dealings.

Risk from other future Omega-3 class drugs (OMTH, NEPT), very mitigated as the aforementioned companies currently do not have FDA approval and their lead drug candidates either have poor therapeutic profiles compared to Vascepa or are highly unlikely to succeed through late stage development and be commercialized as Rx.

Recent chatter/media about poorly constructed Italian OTC class Omega-3 study completely irrelevant to Vascepa and Rx class Omega-3, which perform off different chemical entities, concentrations and dosages. I refer to Anchor (dose dependent at 4g) and Jelis as material indicators for potential Vascepa Reduce-It outcomes.

Conference call likely to revolve (from management's point of view) around expected demand for Anchor and favorable supply and patent position. CC likely to revolve (from analyst and investor perspective) on strategic path for anchor launch.

Semi-fab equipment company launching next-gen products that dramatically improve semi fab efficiency. Likely further partnership with LAM or direct BO from competitor.