Replies to post #57923 on GoodFellas Big Board Catalyst and Chart Plays

[beach_trades]

JPM conference perhaps

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83396666&txt2find=jpm

[SamsaricSufferer]

ACAD +12% on much higher than average volume. Read CN's post from JPM healthcare conference.



This is one of the pearls of the developemental biotechs. Has a real chance for approval in an unserved market worth 1B+ annually in sales.

[SamsaricSufferer]

ACAD 5.67 +8.6% DD and Update

None of this information has changed. Except the trial was very successful. I appended updated info at the end.

Original DD post from Sept. 2012:

"ACAD - More DD Why this time is different.

Primavaserin is being studied as a treatment for Parkinson's disease induced psychosis (PIP). Eventually 60% of Parkinson's patients develop PIP. PIP is very difficult to treat because the drugs used to treat the primary motor symptoms of Parkinson's Disease are blocked by currently available antipsychotic drugs. If you treat the PIP symptoms, the primary motor symptoms get worse. PIP patients are caught in a therapeutic crack between two severe symptom groups.

Parkinson's disease is a disease of aging. All anti-psychotics have a black box warning about their use in the elderly due to the significantly increased mortality and morbidity in dementia patients treated with these agents. This is because of factors such as the increased fall risk and resultant hips fractures in elderly patients on antipsychotics.

ACAD had two previous failed PH III trials for this drug due poor study design. The drug was studied in patients in the Eastern Europe and India, as well as the US. Due to the lower standards of care for PIP patients in Eastern Europe and India, those patients had an usually high placebo effect. The increased care and attention the placebo patients received as a result of study enrollment caused an improvement in the psychosis symptom scores masking primavaserin's drug signal to the point of statistical insignificance. The subset of patients treated in the US showed a very significant response but was too small a sample to power the study statistically. ACAD pulled the plug on the last study early and the stock plummeted.

Endpoints in studies of psychiatric symptoms are subjective. They are prone to placebo confounding. The endpoints are often improvements in symptom inventories scored by observers. These inventories are broadly valid because they are normed on large population samples. However individual patients scores are subject to variability among observers due to differences in training, experience and individual biases.

This is very different from the drug studies used in oncology or cardiology. These studies use endpoints like decreased mortality, progression free survival, lowered cholesterol levels, decreased heart attacks and strokes. These are more objective, easily measured, and quantified endpoints in which the placebo effect can be effectively controlled through double blinding.

ACAD is conducting the present phase 3 study entirely in sites located in the US. All patients enrolled in the study have a 2 week lead in period of socialization and other environmental care enhancements before being randomized to drug or placebo to attenuate the placebo response background. Only the higher and statistically more effective 40mg dose is being studied in the treatment arm. The frequency of evaluation has been decreased, again to decrease the placebo background. The evaluations will be conducted with the patient and primary caregiver via videoconference by a smaller group of evaluators improving consistancy of scoring. The evaluation tool has been simplified and is a 9 item subset of the 20 item Scale of Assessment of Positive Symptoms (SAPS) used previously. This change was agreed to by the FDA as the 9 symptoms being rated were the only ones that apply to PIP. The other 11 items apply to schizophrenia psychosis symptoms and were excluded.

The result is a more rigorously controlled study with a simplified endpoint assessment tool. Primavaserin has been demonstrated safe and very well tolerated with minor adverse effects. The US patient population in the previous studies 40mg treatment arm showed a significant improvement in SAPS scores.

IMO this study has a much better chance of being acceptable to the FDA because of these factors.

1 No other treatment alternative for the given indication.
2 Demonstration of safety and efficacy through the new study design.
3 Improved adverse effect profile versus other antipsychotics, including the newer atypical antipsychotics.

If approved then primavaserin’s use can easily be broadened to other much larger markets such as schizophrenia and bi-polar disorder first through off label use and later through clinical trial validation. It has the potential to be another Seroquel (sales of $3.8B in 2010) or Zyprexa (Sales of $2.5B in 2010).

Sources:

http://www.acadia-pharm.com/pipeline/pimavanserin.htm

ACADIA Pharmaceuticals at Stifel Nicolaus Healthcare Conference Presentation - archived
Wednesday, September 5, 2012 3:50 p.m. ET http://www.veracast.com/webcasts/stifel/healthcare2012/27114337.cfm

http://clinicaltrials.gov/ct2/show/NCT01174004?term=acadia&rank=3

http://seekingalpha.com/article/265370-optimistic-on-acadia-solid-cash-position-increased-confidence-in-phase-3-trial

http://www.dailyfinance.com/2011/02/27/top-selling-drugs-are-about-to-lose-patent-protection-ready/

This is all information available from public sources or my opinion. Do your own due diligence. I have done mine."

Now the Results

Primary Endpoint:

ACAD reported SAPS-PD score improvements of -5.73 from a baseline of 15.88 vs -2.73 from a baseline of 14.73 for placebo. Translated into English patients on primavaserin improved twice as much as patients on placebo with a p=0.0001 in 185 patients with 90 on placebo vs 95 primavaserin patients.

Secondary Endpoints:

"The secondary efficacy measure in the trial was an assessment of clinical global improvement by the investigator using the CGI-I scale. Pimavanserin demonstrated a highly significant improvement on this measure (p=0.001), further supporting its antipsychotic efficacy."

"Pimavanserin demonstrated significant improvements on both nighttime sleep (p=0.045) and daytime wakefulness (p=0.012) on SCOPA."

"Pimavanserin demonstrated a highly significant improvement on the Caregiver Burden Scale (p=0.002)."

Adverse Drug Reactions:

"Adverse events were generally characterized as mild to moderate in nature."
IMO, the ADR's were not statistically significant from the placebo arm.

Also:

"Ninety percent of the patients who completed the clinical phase of this trial elected to roll over into the ongoing open-label safety extension study. Patients were only eligible to participate in the extension study if the treating investigator also deemed them to be likely to benefit from continued treatment with pimavanserin."


Anything you want to know about the trial design is included in the PR. Acadia PR from 11/27/12


The Confirmatory Phase III Trial

From the PR, emphasis added:"Following the successful outcome of this pivotal Phase III trial, we will continue our ongoing preparations for a confirmatory pivotal Phase III trial, the -021 Study, using the same trial design.”

This was confirmed recently at the JPM conference and was the reason for the pop earlier this month, IMO. <link back>

Other Topics:

ACAD raised $86.4M through a dilution via a private stock placement. 19 million shares of stock was sold at the previous day's close of $4.43, not at a discount for $84.2M. The placement also included warrants for 500K shares at 0.001 per share for an additional $2.2M or $4.40 per share. Again the warrants were not sold at a discount. When announced the stock rose to close at 5.14. This was financing from a position of strength and cleared up any overhanging worry about dilution. Financing left it with about $100M COH given the $23M COH MRQ ending 9/30/12 in the 10Q.

http://www.sec.gov/Archives/edgar/data/1070494/000119312512499436/d452263d8k.htm

http://finance.yahoo.com/news/acadia-pharma-rises-following-private-201248220.html

Most Recent 10Q:

http://www.sec.gov/Archives/edgar/data/1070494/000119312512451812/d410323d10q.htm#toc410323_4 Does not include $86.4M raised in December.

ACAD is in an definite uptrend since it put a post trial results bottom in at 4.18 on 12/10/12. It keeps spiking and retracing establishing higher highs and higher lows. It closed above it's post trial surge and close of 5.43 on 11/27. ACAD hit an intraday high of 6.53 on 11/27.

Baker Brothers have taken a 19.9% stake in ACAD.

http://www.sec.gov/Archives/edgar/data/1070494/000114420412069312/v330838_sc13d.htm

Visium Balanced Master Fund has a 6.2% stake.

http://www.sec.gov/Archives/edgar/data/1070494/000119312512512903/d458107dsc13g.htm

It may retrace near term if the pattern holds on these spikes but IMO, this one goes way higher this year.

http://stockcharts.com/h-sc/ui?s=acad