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Acadia Has A Steep Path Ahead

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Strong Bio


  • Lead product sales are ramping up for NUPLAZID, indicated for Parkinson's delusions and hallucination.
  • Research and development expenses for label expansion of NUPLAZID in Parkinson's psychosis, depression, and schizophrenia are ramping up as well.
  • Untapped label expansion trials for NUPLAZID in post-traumatic stress disorder, trauma, and drug abuse markets could further expand its market significantly.

Acadia Pharmaceuticals (NASDAQ:ACAD) is a $3.4 billion market cap company focused on developing treatments for central nervous system disorders with unmet needs. The company's lead product, NUPLAZID (oral Pimavanserin, a selective serotonin inverse 5-HT2A receptor agonist), was approved by the FDA in April 2016 to treat delusions and hallucinations accompanied with Parkinson's disease. It is the only FDA approved drug for this indication. The drug received breakthrough therapy designation from the FDA in 2014.

Acadia's 155 person sales team, with 25 long-term specialists, continues to penetrate NUPLAZID (pimavanserin) into long-term care markets and commercial coverage under Medicare. The company's pipeline continues to advance with ongoing trials including a Phase 2 study in Alzheimer’s disease agitation, schizophrenia inadequate response, schizophrenia negative symptoms, and major depressive disorder. ACAD's Phase 3 study in Alzheimer's disease psychosis is expected to be initiated in 2H 2017. The company has one collaboration with Allergan (AGN) for the development of alpha adrenergic drug candidates to treat chronic pain.

There is clearly a need for treating Parkinson's psychosis. It is considered the second-most "prevalent and burdensome" age-related neurodegenerative disorder behind Alzheimer’s disease. Studies indicate that over the lifetime of the disease, nearly 60% of patients develop some kind of serious psychotic symptoms, with as many as 75% developing visual hallucinations and as many as 60-80% developing auditory hallucinations.

Combine the fact that the 2015 global census data leads to estimates for adults over 65 will increase from 8.5% to 16.7% of the population over the next decade, and we can see that there will be an increasing need for these therapies. It is estimated that one million people in the U.S. have Parkinson's Disease (PD), and over five million people have Alzheimer's Disease (AD).

Prior to approval of primavanserin for PD delusions and hallucinations, clozapine and quetiapine were the

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Strong Bio is a growth-focused analyst seeking identification of unique investment opportunities in biotechnology that arise as high probability market niche innovation or expansion based on scientific peer-reviewed evidence supportive of novel mechanism(s) of action.  By diligently screening investment candidates in multiple biotechnology sectors, initial position recommendations and reinforcing position pricing profiles can be systematically evaluated citing fundamental trends for investors to exploit.  If you would like to request that Strong Bio publish an article on a company of interest, please request by private message.  Strong Bio reminds the reader that investment in biotechnology can be considered high risk, and diversification of assets is a necessity.  Strong Bio is a personal branding of F. Thomas Crump, Ph.D., in an attempt to communicate with a biotechnology stock club that got too large to communicate with by text.  Strong Bio mobile app under construction.

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