Friday, February 27, 2015

ACAD: Fourth Quarter Conference Call ($37.78)

The company reiterated their timeline for filing the new drug application (NDA), with the FDA, for the indication of Parkinson's Disease Psychosis, in the first quarter of 2015.  The company also gave more confidence in starting a phase 2 clinical study for patients with Parkinson's Disease who have experienced sleep disturbances. That trial is expected to start in the first half of 2015.  The currently running phase 2 Alzheimer's Disease Psychosis (ADP) trial is expected to complete, and announce data mid year 2016.  The timeline to announce that data has been steadily pushed back in time, previously stated as a two year trial (November 2013 - November 2015) to around two and a half years now. The company has stated that patient selection for the study is a critical process for trial success.  The stock is trading near all-time highs, with a market cap of approximately $3.8 billion. Below is a daily chart.  Thank you for reading.
 

Saturday, February 21, 2015

Top Selling Drugs in 2014

The top selling U.S. drugs by sales (as opposed to prescriptions) in 2014 are listed below. The sales were tracked on a 12 month rolling basis from mid 2013 to mid 2014 by research firm IMS Health.

1.  Abilify $7,240 billion

2.  Humira $6,310
3.  Nexium $6,303
4.  Crestor $5,672
5.  Enbrel $5,097
6.  Advair Diskus $5,064
7.  Sovaldi  $4,469
8.  Remicade $4,342
9.  Lantus Solostar $3,829
10. Neulasta $3,688

Abilify achieved the number one spot in 2014 despite receiving an FDA issued black box warning in 2006.

Elderly people with psychosis related-dementia treated with antipsychotic 
medicines including ABILIFY, are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of patients with dementia-related psychosis.

I continue to believe that Acadia Pharmaceutical's drug Nuplazid will become palliative care for the elderly, and follow in the footsteps of Abilify, on a sales growth basis over time. The drug has shown an improved safety profile to that of other atypical antipsychotics already approved. The company has mentioned that a clean label is highly probable when Nuplazid gets approval for Parkinson's Disease Psychosis in 2015.  A clean label for Nuplazid could prompt Neurologist and Psychiatrists to switch at a high rate, and prescribe the drug more readily off-label for similar indications. Sales will likely start strong, as new patients will be prescribed Nuplazid for Parkinson's Disease Psychosis (PDP), existing patients under another therapy will switch at a high rate, and the drug could eventually become an add-on, to existing therapies in other areas, such as cognition. Thank you for reading.   

Monday, February 16, 2015

Alzheimer's Disease - Clinical Trial Success Rate .4%

There has not been a newly approved drug for Alzheimer's Disease since 2004, when Namenda (memantine) was approved to treat the symptoms in moderate to severe AD. In research initiated by Jeffrey Cummings of Cleveland Clinic Lou Ruvo Center For Brain Health, Alzheimer's disease drug-development pipeline: few candidates, frequent failures, found that 244 compounds were assessed in the decade from 2002 to 2012, one was approved for marketing; excluding the 14 compounds currently in phase 3, the success rate for advancing agents for regulatory approval was 0.4% (99.6% attrition). The success rate is among the lowest in any therapeutic area.  The attrition rate for AD treatment is high, with 72% of agents failing in phase 1 clinical trials, 92% failing in phase 2, and 98% failing in phase 3 during the period of 2002 to 2012. Most trials address symptomatic agents to improve cognition, and most therapies address amyloid-beta targets than any other. Thank you for reading.

Monday, February 9, 2015

Analyst Price Targets for Acadia Pharma

The list of analyst covering Acadia Pharma has grown, and so has the price targets they are anticipating in the future.  So, below is a list of a few that have recently updated price projections.

Price Target:
2-24-15  Wainwright: $50.00
2-5-15  Roth: $42.00
11-21-14  Cowen: $46.00
9-22-14  JP Morgan: $33.00

The predominate theme among the analyst is that FDA approval of Nuplazid (pimavanserin) for Parkinson's Disease Psychosis (PDP), is a very high probability event to occur in 2015. Below are the revenue estimates for PDP in the U.S. that Acadia will be addressing with a direct sales force of approximately 135 representatives.

U.S. Peak PDP Revenue:
2-5-15 Roth:  $2.7 billion 
11-21-14 Cowen:  $1.1 billion 
9-22-14 JP Morgan:  $1.0 billion 

US Patent for Nuplazid (pimavanserin) runs to mid 2028.

Bottom Line:  Always interesting to see what analyst are thinking with their price targets and revenue estimates.  The above revenue estimates exclude Europe and the rest of world for PDP. Also, excludes any revenue for Alzheimer's Disease Psychosis (ADP), Schizophrenia, or sleep maintenance. Thank you for reading.