Updates on 3 Heavily-Watched Companies With Recent Launches Print E-mail
By Brian Wilson - Lead Contributor   
Monday, 22 July 2013 11:46
Amarin (NASDAQ: AMRN) is continuing to commercialize Vascepa – their omega-3 pill which contains over 95% eicosapentaenoic acid. The drug, which launched back in Janury 2013, is getting closer to meeting Wall Street’s sales estimates (a ballpark estimate of $1.5 M in sales per week) on stagnant/declining sales of competing omega-3 pill Lovaza, although the stock has been extremely weak despite heavy buying interest in the biotech and specialty pharmaceuticals sector. The stock recently hit 52-week lows and remained depressed after a recent financing, although AMRN seems to have stabilized.

Investors are still paying attention to Vascepa prescription data, although more interest in being generated by the company’s upcoming catalysts. Of particularly interest is the scheduling of an FDA adcom for the ANCHOR sNDA, which expands Vascepa’s hypertriglyceridemia indication to patients with over 200 mg/dL and essentially grows Vascepa’s target patient population tenfold. The adcom is scheduled for October 16th 2013, while the PDUFA goal date is December 20th 2013. December 2013 and January 2014 options have become very expensive, and should remain this way as long as the catalysts remain. The stock is generally expected to stay rangebound leading up to these catalysts, although investors should note that a surprise NCE decision or data release could move the stock significantly.

Vivus (NADSAQ: VVUS) Qsymia (phentermine, topiramate ER) prescriptions rose 17% last week (versus two weeks ago) driven heavily by precriptions filled at brick and mortar stores. This is a confirmation of an expectation started back in April 2013 that a removal of the restrictive REMS amendment that limited Qsymia to mail order pharmacies during its initial launch phase would drastically boost the drug’s performance on the market. Qsymia, which is the most efficacious prescription obesity drug on the market (based on clinical trial data). Note that there are still lingering concerns regarding the cardiovascular risk profile of phentermine (one of the two active ingredients of the drug), although a growing base of primary care physicians seem to view obesity as a bigger threat.

Also interesting from Vivus is the apparent conclusion of the proxy battle between First Manhattan and Vivus management. The board was expanded to 11 members, from 9, with 6 nominees that were placed by First Manhattan. This should put an end to the volatility introduced by the proxy battle, since the probability of a bidding war has dropped.

Arena (NASDAQ: ARNA) is having trouble launching Belviq (lorcaserin), which seems to be spooking the shareholders who were expecting the drug to crush Qsymia with ease. Although it’s too early to draw any solid conclusions, the market is clearly disappointed with ARNA. The stock recently made a 52-week low of $6.65/share, and is struggling to break a steady downtrend. Having said this, the drug is still making progress – prescriptions rose every consecutive week since launch except for the holiday week of June 30th to July 5th. Many more details should be available when the company presents Q2 earnings in August.




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