2012-11-28 00:50:31 -
By Scott Matusow, Contributor
Acadia Pharma (NASDAQ: ACAD)
Acadia announced today successful top-line results from its pivotal Phase III
trial evaluating the efficacy, tolerability and safety of Pimavanserin in
patients with Parkinson's disease psychosis (PDP). Pimavanserin is Acadia's
proprietary, non-dopaminergic product candidate that selectively blocks
serotonin 5-HT(2A) receptors. Pimavanserin met the primary endpoint in the Phase
III trial by demonstrating highly significant antipsychotic efficacy as measured
using the 9-item SAPS-PD scale (p=0.001). Pimavanserin also met the key
secondary endpoint for motoric tolerability as measured using Parts II and III
of the Unified Parkinson's Disease Rating Scale, or UPDRS. These results were
further supported by a highly significant improvement in the secondary efficacy
measure, the Clinical Global Impression Improvement, or CGI-I, scale (p=0.001).
In addition, clinical benefits were observed in all exploratory efficacy
measures with
significant improvements in nighttime sleep, daytime wakefulness
and caregiver burden. Consistent with previous studies, Pimavanserin was safe
and well tolerated in this Phase III trial.
However, the company needs to conduct another Phase III trial of Pimavanserin in
Parkinson's patients in order to confirm Tuesday's results. Two previous late-
stage studies of the drug failed to demonstrate a significant reduction in
psychotic episodes -- this is why I believe it's a sure fire short-sell
currently.
Amicus Therapeutics, Inc. (NASDAQ: FOLD)
A potentially big catalyst coming up for Amicus is the release of the phase III
results related to its medication for Fabry disease.
On September 6th, Amicus issued a press release to update the screening profiles
related to this study. Labeled study 011, this is one of two ongoing Phase 3
studies of migalastat HCl monotherapy being conducted by Amicus and
GlaxoSmithKline (GSK)
The primary endpoint target in Study 011 is a change in interstitial capillary
GL-3 as measured in kidney biopsy at 6 months versus baseline. The six month
primary treatment period in Study 011 was completed in the second quarter of
2012 and the six-month follow-up period is expected to complete in the December
2012. Amicus and GSK will also un-blind and analyze data from the primary six
month treatment at this time. Currently, both companies remain blinded to all
results.
There has been historic difficulty in finding successful treatments for rare
genetic diseases. If Amicus can show successful phase III data here, it could
very well be like a "kodak" moment in medicine's war against genetic diseases.
Amicus has the potential to be a double from its current price level on positive
Phase III data, much like we have seen this morning with Acadia -- in my
opinion. Also, GSK owns 20% of Amicus, so a buyout is possible on positive data
here, as this has been GSK'S M.O in the past. Because of these factors, Amicus
could easily see a double in its stock price as we saw with Acadia this morning.
With a market cap of $260.49M and GSK already owning 20% of the company, I can
easily see a buyout price of $600M which would cost GSK a lot less due the above
mentioned fact of current ownership in the company.
Anacor Pharmaceuticals (NASDAQ: ANAC)
Anacor has seen a recent spike in its stock price as traders and investors have
begun to take notice of several catalysts upcoming in the near term for the
company.
Anacor plans to announce top-line data for Tavaborole in January 2013 for the
first Phase III trials related to this drug in treating Onychomycosis. Six weeks
later, the company expects the second trial results to be publicized for this
same indication. Onychomycosis is a fungal infection of the nail and nail bed
that affects approximately 35 million people in the United States. The company
plans to file an NDA for tavaborole in mid-2013, subject to the results of the
phase three trials.
By the end of this year, Anacor plans to announce data from the phase two
safety, pharmacokinetics, and efficacy study related to AN2728. AN2728 is a
topical anti-inflammatory product candidate for the treatment of dermatitis and
psoriasis in adolescents. The company expects to initiate phase two trials in
children ages 2-11 shortly after the announcement of these results. Atopic
dermatitis is a chronic rash characterized by inflammation and itching and
affects an estimated 10% to 20% of infants and young children. Psoriasis is a
chronic inflammatory skin disease that affects approximately 7.5 million people
in the United States and over 100 million people worldwide.
The treatment, if eventually FDA approved, would compete against Sanofi's (SNY)
Penlac and Novartis's (NVS) Lamisil.
To offer an idea of the potential market for Tavaborole, Penlac at its peak
realized $330M world wide sales, while Lamisil realized $1.2B in peak sales. If
Tavaborole ultimately gains FDA approval, the treatment could prove itself a
very strong revenue generator for Anac.
Based on it's current market cap of $199.54M, Anac seems rather undervalued at
this level. A stock price of at least $6 a share is where it should be trading
in my opinion, with a longer term price that should be seeing $10 a share, if
everything goes correctly for the company.
Long: ANAC, FOLD
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