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 .04%

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. 

Saturday, January 31, 2015

Nuplazid for Juvenile Psychosis

Acadia plans to run a phase 2 trial using their lead drug Nuplazid (pimavanserin) for juveniles with psychotic symptoms in the second half of this year.  This is an area that would be addressing an unmet need, because the current anti-psychotics being used today have been difficult to tolerate for an extended period of time. Some of the side effects exhibited include weight gain, high blood sugar, pleasurelessness, movement disorders, low energy and motivation. The current drugs being used for this age group include, Risperdal, Zyprexa, Serequel, Geodon, Clozaril, and Abilify.  The company plans on testing Nuplazid for patients in the maintenance phase of schizophrenia, which is the time period between acute psychotic episodes, and it will be tested as mono-therapy treatment. We'll have more to say on this trial, and the market opportunity in the future. Thank you for reading.

Wednesday, January 14, 2015

Acadia - JP Morgan Healthcare Conference ($33.76)

Acadia (ACAD) presented yesterday at the annual JP Morgan Healthcare Conference.  Not much new information was presented, just a reiteration of timelines, and current, and future clinical trials.  The breakout session afterwards yielded a few questions regarding their phase 2 ADP (Alzheimer's Disease Psychosis) trial.  
  • The company is looking for a -3 point reduction from placebo on the hallucinations and delusions sub-scale at six weeks, as primary endpoint.
  • Also at six weeks into the trial, they will be using a more broad scale, the NPI - NH (Neuropsychiatric Inventory-Nursing Home) and the CMAI-SF (Cohen Mansfield Agitation Inventory - Short Form) respectively.  The NPI-NH scale encompasses behavioral as well as psychosis as one complete measure.
  • At 12 weeks, they will measure cognition, functional and behavioral performance since the beginning of the trial using the ADCS - CGIC (Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change).
Bottom Line:  Management did another fine job explaining the science, clinical trial updates, and timelines for 2015.  Thank you for reading.

Sunday, January 11, 2015

Lundbeck Clinical Trials - Update

Lundbeck and their marketing partner Otsuka (the manufacturer of the #1 selling drug Abilify) are major players in the central nervous system (CNS) space.  An update on new phase 3 trial data for depression and schizophrenia are listed below.  The links are below.

Lundbeck 2014 Press Releases
Trial: (NCT01360645) Phase 3
Brexpiprazole as adjunct for Major Depressive Disorder (MDD)
Study 1 (2mg + ADT (N=175): -3.21, p=0.0002)  MADRS

Lundbeck 2014 Press Releases
Trial: (NCT01396421) Phase 3
Brexpiprazole as mono-therapy for adults with Acute Schizophrenia.
Total Score (4mg: -19.65, p=0.0006) PANSS

Both studies achieved significant efficacy results, which may lead to approval from the FDA mid 2015.

Saturday, December 27, 2014

"Anecdotal Reports"

Is what Acadia Pharmaceutical CEO Uli Hacksell said he was receiving from the current phase 2 ADP (Alzheimer's Disease Psychosis) trial, during the recent Oppenheimer Healthcare conference on December 10th. He mentioned in addition to the anti-psychotic and sleep benefit from Pimavanserin, there were other potential benefits that Pimavanserin could provide for Alzheimer's patients; such as agitation, anxiety, aggression, and cognition.  Regarding cognition, the CEO believes that Pimavanserin may not increase cognitive loss at the same rate that current Atypical Antipsychotics do.
There has been much mentioned over time about cognition from the CEO and others at Acadia as it pertains to Alzheimer's patients.  The current standard of care involves a group known as cholinergic drugs. The list of current cholinergic drugs approved for cognition/maintenance in Alzheimer's patients are listed below.

Aricept (donepezil) - Approved for all stages of Alzheimer's.
Exelon - Approved to treat mild to moderate Alzheimer's.
Razadyn - Approved to treat mild to moderate Alzheimer's.
Namenda - Approved for moderate to severe Alzheimer's.

Acadia stated that Pimavanserin used with cholinergic drugs has been shown to increase cognition in pre-clinical animal trials.  If it proves out in the current ADP trial, that Alzheimers patients taking Pimavanserin with their cholinergic drug, do not lose cognition at the rate seen with current antipsychotics, then it will be another improvement, alongside other safety factors that Pimavanserin has shown.  The read-out from the ADP trial will be around the fourth quarter of 2015. Thank you for reading.

Friday, December 19, 2014

Acadia Pharma 2015 Event Sheet

Here are some interesting events, with timelines to remember for 2015.

1. Filing of the NDA in the first quarter of 2015.
2. 60 days for the FDA to accept the application.
3. Upon potential acceptance, FDA could also grant priority review. 
4. With priority review, six months PDUFA date, without, 10 months.
5. Sleep disturbance trial for PDP patients first half of 2015.
6. EU filing 6- 9 months post FDA filing, so around 3rd quarter. 
7. Potential top line ADP in fourth quarter of 2015 or around end of 2015. 
8. Schizophrenia maintenance trial to commence 2nd half of 2015. 
9. More information on Pima for Autism 2015.

Sunday, December 14, 2014

A Technical Look at Acadia Pharma ($32.53)

Some charts of Acadia as the stock is now making new highs on a weekly basis.
Above daily chart is a nice looking breakout to new highs.  Even though overbought somewhat on the daily, the chart can stay overbought for much longer on a technical basis.  
On a comparative basis, ACAD has outperformed the XBI biotech sector and the S&P 500 the last three days, as the market has sold off.  Thank you for reading.  We hold ACAD as a long term investment.  

Monday, December 8, 2014

MEI Pharma: ASH and Investor Conference Update

MEIP just finished with their annual investor / analyst conference this evening and ASH on Saturday. There are a few issues at hand that have left me to believe that Pracinostat / Vidaza combination for Newly Diagnosed Elderly Patients with AML, may not be the combo that achieves a significant improvement over existing therapy for these patients.  At least as far as overall survival may be concerned.  The company has released positive interim CR (complete remission) data throughout the phase 2 AML trial.  What we did not hear, up until the investor conference is below.

1. Six patients out of 41 had to have dose reduction.  First Vidaza then Pracinostat reduced, with the majority being Vidaza reduced out of six.
2. The company is planning a 450 patient phase 3 AML trial in June 2015, with a planned primary end point being (CR) or complete response, and secondary endpoints being overall survival (OS), overall response rate (ORR) transfusion independence rate, duration of response, progression free survival (PFS), tolerability and AE rate.  But the company said that discussions with the FDA is still ongoing, and will have to see if the CR is a valid primary endpoint for the filing of an NDA.
3. The age group for this AML phase 3 trial in elderly population is planning on being lowered from greater or equal to 65 years, down to greater or equal to 60 years of age.

The reason that the company is planning a phase 3 trial using CR as the endpoint could be because of the lowering of dose in the current trial. Patients may be exhibiting greater side effects than initially thought.  If that is the case, the lowering of the dose could impact overall survival, and may be the reason that they are planning a phase 3 trial using CR as the primary endpoint rather than OS.  There has to be a trade off between receiving enough of the drug for efficacy and the safety profile for the elderly population.  In this case, with six patients, the lowering of the dosage of Vidaza to keep patients on therapy was the step taken.  The inclusion criteria for the planned phase 3 trial of 60 years of age rather than the current trial design of 65 years, is another reason to believe that the combination may be too adverse for patients 65 years and older, and that an extra five year reduction could make the drug combination more tolerable.  

Tuesday, December 2, 2014

MEIP: Completes Enrollment Front Line AML

Today MEI Pharma announced that enrollment for their phase 2 trial for patients who are elderly, newly diagnosed with AML (acute myeloid leukemia) is complete.  This trial enrolled 50 patients extremely fast since August 1st, when they only had 14 total enrollments.  Since then, the company announced that they achieved 8 (CR) complete remissions, or 57% in November with no progressions...

Avanir Pharmaceuticals: Buy Out

A busy day as one of the stocks we hold received a buyout offer from Otsuka Pharmaceuticals (the maker of Abilify) for $3.54 billion or $17.00 per share, in a stock transaction. My initial impression is that Otsuka received a good deal, as they will get a nice pipeline including indications such as agitation / aggression in Alzheimer's patients (phase 3 2015), along with Major Depressive Disorder or (MDD), which is in the early stages of a phase 2 trial.  AVNR patents extend out to 2030.  

Monday, November 24, 2014

Acadia Pharma: New High ($29.53)

Acadia has closed at a new all-time high on a inter-weekly basis.  The stock finished the day strong, on above average volume.  Below is a weekly chart of ACAD.
Bottom Line:  Even though the company announced a short delay for filing their new drug application for Nuplazid, the stock held up well, and has actually advanced higher.  Last week, the analyst house Cowen Group, provided coverage on ACAD with a buy rating, and a $46.00 price target on the stock. Perhaps that, and a strong biotech sector has contributed to the new high.  Thank you for reading.  We currently hold ACAD, and AVNR.  

Thursday, November 20, 2014

MEI Pharma: AML Trial Update ($6.90)

Trial updates are coming in quite fast now, as companies seeing positive results want to bring that information to the public as soon as possible. Many are scheduled to appear at the ASH Conference on December 6th. MEI Pharma just updated investors on their AML phase 2 trial using Pracinostat (an HDACi) in combination with Vidaza for elderly newly diagnosed patients...

Thursday, November 13, 2014

MDS & AML: Assessing the Landscape

There has not been an effective, and safe, FDA approved drug for MDS (myelodysplastic syndrome) or AML (acute myeloid leukemia) since Vidaza in 2004 and Dacogen in 2006.  This post will examine the competitive landscape of companies with the hope of meeting the unmet need for MDS and AML patients...
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