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Steve Rosenman
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Mr. Rosenman has nearly 15-years executive experience in the health and wellness sectors, including weight loss, cosmetics skincare and nutrition, both Rx and OTC. Expertise areas include strategic market and product planning and corporate development (evaluation, recommendation and execution of... More
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  • VVUS Attractive At Current Levels

    At current levels, I view VVUS as a buy opportunity and cite that the newly installed management board has the experience and proven history to steer the company into the hands of a better suited pharma company-- to market their lead weight loss product. This road may not be easy or quick though, as the drug has some regulatory hurdles to get around before full marketing potential is realized. Therefore, interested partners/suitors may have to sit on the sideline while the company makes progress on the regulatory / marketing front.

    For this reason, a buy at these levels with a conviction to hold at least 12 months should provide promising returns. My 12-mo target would be $15-17.

    I do not like any of the other weight loss drugs in this space.

    Tags: VVUS
    Sep 17 3:16 PM | Link | 3 Comments
  • Explosive Bidding Situation Setting Up For Amarin

    Several recent developments flying under the radar right now:

    The patent appeal that is unfavorable to GSK presents three major strategic plays to acquire Amarin (NASDAQ:AMRN):

    1. GSK main player - in order to defend against Lovaza revenue loss from potential future generics

    2. AZN back in as a suitor - in order to maintain a player in the Omega-3 space --the Lovaza generic ruling cancels out Omthera completely

    3. Teva now makes more sense - in order to lock up the Omega-3 drug class and price protect against other generic plays

    Also, AMRN has named Lipator as the stain agent to be patented with Vascepa. That means PFE prime suitor as well.

    I will reiterate my stand on NCE success, Anchor approval in December and a $28-32 short term (within 12-mo) price target.

    Tags: AMRN, TEVA, PFE, GSK, AZN
    Sep 16 2:00 PM | Link | 46 Comments
  • Note From Aegis On AMRN Situation
     

     

    Teva / Par Lovaza Win Is A Blip: Reiterate Buy

     
    • Generic Lovaza May Still Be Years Away. Yesterday, it was announced that Teva Pharmaceutical Industries (TEVA/NYSE, Not Rated) and Par Pharmaceutical Co. (Private) had won an appeal against Pronova BioPharma in the U.S. Court of Appeals in their ongoing battle to obtain the right to launch a generic version of Pronova's Lovaza (omega-3-acid ethyl esters) in the U.S. We believe that the negative reaction to this news by Amarin investors was both ill-considered and unwarranted. In anticipation of approval of Vascepa™ in mixed dyslipidemia in December 2013, we reiterate our Buy rating and 12-month price target of $30.00 on Amarin shares.
    • Teva / Par Victory Does Not Mean Curtains For Amarin. We believe that the Lovaza patent news yesterday is of minimal relevance for several reasons. First, this appeals court decision does not automatically allow Teva and Par to begin marketing a Lovaza generic in the U.S. The case was yesterday remanded back to the lower district court, which in 2012 ruled in favor of Pronova. Second, we believe that Teva may have problems accessing sufficient fish oil supply to even make a generic version of Lovaza at commercial scale. Third, even if Lovaza generics eventually appear in the U.S., we believe that Amarin's Vascepa will remain viable as a commercial franchise because we remain optimistic that the drug will be approved near-term for use in mixed dyslipidemia. As we have stated repeatedly in the past, Lovaza cannot secure a label in mixed dyslipidemia as it elevates LDL-cholesterol. Thus, if Vascepa receives a mixed dyslipidemia label it should effectively become immune to cheaper competitors like Lovaza generics.
    • No Free Ride For Generics. We would remind investors that overturning the Lovaza patent estate is not a particularly noteworthy achievement. One of the Pronova patents initially challenged by Teva and Par expired in March of this year, while the other (the '667 patent) expires in April 2017. Investors would be well-advised to remember that even if generic filers win on the litigation front, they still have to obtain FDA approval for their copycat drugs. Thus far, the FDA has yet to approve a single Lovaza generic. Again, even if generics of Lovaza were to appear, they would not have a label in mixed dyslipidemia and would not be usable in that indication as reimbursement agencies would not be able to pay for them.
    • FDA Advisory Panel Does Not Present Cause For Concern. A panel vote on the approvability of Vascepa in mixed dyslipidemia is taking place on October 16, 2013. There is substantial cardiac outcomes-based evidence, most notably from the well-powered GISSI-Prevenzione and JELIS studies, that prescription-grade omega-3 fatty acids like Vascepa improve cardiovascular outcomes and reduce deaths in mixed dyslipidemia patients.
    Tags: AMRN, GSK, AZN
    Sep 13 9:39 AM | Link | 13 Comments
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