We started back into Acadia Pharmaceuticals today, after being extremely patient, since selling shares the morning that the CEO announced resignation in March 2015. We wrote about that here, Acadia CEO Resigns - Effective Immediately. Fundamentally not much has changed with their lead drug Nuplazid. They have an FDA potential approval date of May 1st, 2016. A list of important reiterating facts are below.
-Nuplazid will be the only approved drug for Parkinson's Disease Psychosis (PDP).
-Their patent runs through 2028 (prior to any Hatch-Waxman addition) in the U.S. and 2025 in the EU. So approximately 12 years of exclusivity U.S., unless a new drug comes to market during that time frame.
-The drug could receive premium pricing up to around $15,000 per year for PDP patients, and be seen as a cost savings for family and the medical system.
-Nuplazid may have the potential to treat Alzheimer's Agitation, which at present is another unmet need, as the company plans to run a phase 2 clinical trial mid 2016.
-The drug could potentially be used as maintenance therapy for schizophrenia patients, as a safer alternative to current anti-psychotics.
-The company currently has around 124 mn shares outstanding.
-Their cash position is around $500 mn.
-ADCOM (advisory committee) will meet on March 29th.
Bottom Line: A weak overall market and biotechnology in particular, has allowed us to buy back shares of ACAD at reasonable prices. I am expecting a black box warning label upon approval around May 1st, but do not believe that will have a major impact on the success of Nuplazid for PDP. Thank you for reading.
-Nuplazid will be the only approved drug for Parkinson's Disease Psychosis (PDP).
-Their patent runs through 2028 (prior to any Hatch-Waxman addition) in the U.S. and 2025 in the EU. So approximately 12 years of exclusivity U.S., unless a new drug comes to market during that time frame.
-The drug could receive premium pricing up to around $15,000 per year for PDP patients, and be seen as a cost savings for family and the medical system.
-Nuplazid may have the potential to treat Alzheimer's Agitation, which at present is another unmet need, as the company plans to run a phase 2 clinical trial mid 2016.
-The drug could potentially be used as maintenance therapy for schizophrenia patients, as a safer alternative to current anti-psychotics.
-The company currently has around 124 mn shares outstanding.
-Their cash position is around $500 mn.
-ADCOM (advisory committee) will meet on March 29th.
Bottom Line: A weak overall market and biotechnology in particular, has allowed us to buy back shares of ACAD at reasonable prices. I am expecting a black box warning label upon approval around May 1st, but do not believe that will have a major impact on the success of Nuplazid for PDP. Thank you for reading.
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