Acadia: Progress on Parkinson's?

06/10/2016 7:00 am EST


Russ Belden – guest editor for John McCamant’s The Medical Technology Stock Letter – looks at one of the newsletter’s recommendation biotech holding and the upcoming commercial launch of its a Parkinson’s disease treatment.

Acadia (ACAD) will soon be taking the wraps off the commercial launch of Nuplazid (pimavanserin) for Parkinson’s disease psychoses (PDP).

The FDA provided ACAD with a very broad Nuplazid label in PDP including the most inclusive PDP population possible.

With that label, a high degree of unmet need in PDP and a target product profile that significantly reduces psychoses without impairing PD motor symptoms, in our view, Nuplazid is a blockbuster drug in the making.

Our assumption is that Nuplazid creates a new standard of care in PDP and commands an 80% market share through at least 2024.

With the lengthy delays in the NDA filing in the US, the commercial team led by Executive VP Terry Moore has had ample time to prepare both the market and product for commercial launch.

They have also done extensive work in profiling the neurology, psychiatry MD segments and skilled nursing facilities to strategically design a 133 representative sales force for coverage.

We see Nuplazid having blockbuster potential in PDP alone. Other potential indications can easily double or triple those revenues.

The Michael J. Fox Foundation conducted a PDP webinar on May 19th with the PDP physician community, the MJ Fox Foundation and a courageous husband of a PDP sufferer.

They were all extremely excited about the Nuplazid approval calling it a “break through drug” and described its potential to dramatically improve the lives of PDP patients and their caregivers. In our view, these are important endorsements.

There are several other 2016 catalysts including the EU regulatory filing, the Phase II Alzheimer’s psychoses data and potentially the initiation of the Alzheimer’s agitation and schizophrenia trials.

Meanwhile, as an “unencumbered” company (e.g. no ex-US partner), with a blockbuster drug in neurology and $457m in cash, ACAD certainly makes an attractive takeout opportunity as the M&A continues to heat up.

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By Russ Belden, Guest Editor for The Medical Technology Stock Letter