ACADIA Pharmaceuticals Inc (ACAD) Message Board

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Biotech / Medical : ACADIA Pharmaceuticals Inc (ACAD)

ACAD 22.69

-0.1%

3:59 PM EDT

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To: mopgcw who wrote (540)	8/14/2009 8:26:59 PM
From: mopgcw	of 588

Citi: ACADIA Pharmaceuticals Inc (ACAD) Binary Event Preview: Ph. 3 Pimavanserin PDP Data Expected 3Q; Demanding Trial; But Potentially Large Market Opportunity ? Ph. 3 Results Major Event — Data from first Ph. 3 trial for Pimavanserin in Parkinson’s disease psychosis (PDP) is expected in 3Q. Positive results could drive ACAD to ~$15 level (based on 6x royalty on peak sales of ~$400 to $500M); negative results could push shares down to cash level of ~$1. ? PDP Represents Real Unmet Need with no approved Tx — Approximately 300K of the ~1.6M Parkinson’s patients experience psychosis. Currently offlabel used drugs carry black-box warning and/or have no data to support their use in PDP. If approved, we think ACAD’s partner, Biovail, will develop Pimavanserin for psychosis associated with other conditions. ? Ph. 3 Trial Design — Trial enrolled 298 pts randomized to 10mg or 40mg Pimavanserin, or Placebo, over 6 week treatment period. The primary endpoint is antipsychotic efficacy measured by the SAPS scale. For successful trial, at least one Pimavanserin arm must hit p<.025 vs. placebo. ? Key Positive is Mechanism of Action (MOA) — Pimavanserin, a 5HT 2A inverse agonist, has a similar MOA to low-dose clozapine, the only drug that has shown efficacy in PDP. ? Key Negative is the Metric — SAPS scale (1° endpoint) was designed for schizophrenia, not PDP. Many of the items on the scale do not apply to PDP patients and it is not clear how well it captures the treatment effect.

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