Neurogen Hoping Aplindore Data Kick Starts a Rebound
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October 14, 2008 Neurogen hoping aplindore data kick starts a rebound Evaluate Vantage As one of the worst performing pharma or biotech stocks so far this year, Neurogen provided beleaguered investors with some much-needed positive news today that its phase II candidate aplindore displayed encouraging efficacy and safety data in the treatment of restless legs syndrome (RLS) and Parkinson’s disease. Neurogen’s shares, having lost almost all their value this year (Companies on the way to being 2008's winners and losers - US focus, August 7, 2008), jumped as much as 35% in early trading today to $0.31. However, with the stock threatened with de-listing from the Nasdaq exchange if the shares do not consistently trade above $1 by February and still only priced at half the current cash per share value of $0.63, the company still has some way to go win back investors who have clearly fled the stock this year. Encouraging side effect profile Aplindore is a partial dopamine agonist, similar to GlaxoSmithKline’s Requip which is approved to treat both RLS and Parkinson’s disease and last year recorded sales of $693m. However, with expiry of the drug’s main patent in May, sales are expected to decline 16% annually over the next seven years to a relatively modest $200m by 2014. Therefore, with generics set to be firmly established by the time aplindore reaches the market, Neurogen is pinning its hopes on the fact this dopamine agonist does not cause some of the occasionally debilitating side effects which can result from using currently approved RLS and Parkinson’s treatments. The phase II data released today showed aplindore met its primary efficacy endpoints in both trials, with a particularly comparable side effect profile to placebo in the RLS trial. However, the data set was not entirely positive with the Parkinson’s trial failing to produce a robust dosing effect, as the highest doses failed to demonstrate significant efficacy levels. Adipiplon setbacks One of the main reasons Neurogen’s shares have suffered so much this year is due to the developmental setbacks for the company’s lead pipeline drug adipiplon to treat insomnia. A pivotal phase II/III trial was delayed in April and then completely suspended in July, due to a higher than expected rate of unwanted next day effects such as excessive grogginess and amnestic events. Neurogen believes these adverse events may have been caused by the bilayer tablet formulation, used for the first time in this trial, not performing as expected. With the company conducting an investigation into what went wrong, the only remaining short-term catalyst for Neurogen’s shares rests with the results of a phase II trial for adipiplon to treat anxiety, due by the end of the year. With today's reasonably positive news failing to return the shares back to the relative safe haven level of $1, where they were just three months ago, Neurogen will be desperate for more positive data to help maintain the momentum of this mini-revival. More from Evaluate Vantage Evaluate HQ 44-(0)20-7377-0800 Evaluate Americas +1-617-573-9450 Evaluate APAC +81-(0)80-1164-4754 © Copyright 2021 Evaluate Ltd..