Acadia Has Tough Road Ahead With Nuplazid Success

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Mar 15, 2015

The shares of the Acadia Pharmaceuticals (ACAD, Financial) are in trouble waters as it has slipped by over 20% on extremely high volumes yesterday. There are reasons at play behind this sudden nosedive and analysts believe them to be the lackadaisical move by the pharmaceutical company itself that pushed the sales in a dungeon.

The company was previously researching on the Parkinson disease psychosis drug Nuplazid which was about to be launched during this quarter in the second half of the year and was further delayed citing issues with their competency to manufacture the drug on a commercial scale, raised apprehension in investors hence resulting in such a result.

Acadia’s claim to fame

Acadia in 2014 was quite the achiever and the list was marked by some of their important achievements. They were head on into the research of Nuplazid for the treatment of Parkinson’s disease psychosis (PDP) which was a well thought move and was supposed to go for FDA approval this quarter.

They also clocked a significant growth in drug-drug program and their stability program for registration batches followed by some successful pre-NDA meetings with the FDA. FDA also granted them breakthrough therapy designation for NUPLAZID which is worth a mention. PDP is a disease whose cure still demands a lot of research and the designation that FDA assigned to Acadia was a major step towards eradication of the disease. Seems like quite a responsibility for Acadia to match up to the world’s expectations.

Acadia’s Tough Ride Ahead

Coming back to the hard hitting reality that caused the downfall for Acadia, there remains many reasons to discuss on. The first being the Bio-pharmaceutical company announcing on Wednesday afternoon the retirement of its CEO Uli Hacksell who was also a member of its board of directors pulled strings to stop the shares from soaring. The company updated that their Chief Financial Officer Steve Davis will take over as interim CEO.

In a recent announcement Acadia added that during the second half of the year they will submit for Nuplazid approval as they had changed the timing of its planned New Drug Application (NDA) although they had previous plans to submit the application in the first quarter.

In view of its poor market performance analysts assume that Acadia Pharmaceuticals needs solemn help with Nuplazid. They are also a little too apprehensive over the incompetency of Acadia to develop Nuplazid in a commercially viable process, which is yet to see the FDA’s nod. The only factor regarding the FDA’s approval in favour of the pharmaceutical giant is the breakthrough therapy designation for NUPLAZID that it has earned from FDA, apart from which everything that concerns FDA’s approval is still unsorted.

The need of the hour is having an effective commercial manufacturing procedure in place to handle high demand which would play a positive catalyst for FDA’s approval. It is a challenge now for Acadia to prove that it can match up to the tentative demand of one million plus Parkinson disease patients in the U.S. There is no determined measure of PD affected patients in the U.S. it could range from 20% to 50%, it is now for Acadia to ensure that they can supply Nuplazid to the latter smoothly without any glitch in production chain.

Last Thoughts

It will be hence a pivotal year for Acadia and to stand up to the expectation, Acadia will use the previous year’s accomplishments as bedrock. As they near the submission of their NDA, work for FDA approval and is preparing the stage to launch Nuplazid in a big way across the United States it remains to be observed how efficiently and effectively the new management handles the high pressure work schedule. If everything goes fine from here it can bolster Acadia to new highs in the pharmaceutical sector.