Acadia Pharmaceutical - "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.

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.

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. 

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, for accelerated approval, and overall survival (OS) follow-up data for full approval.  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.

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.