So, as if investors didn’t have enough to be happy about, news got even better in 2013. On April 11, ACADIA announced that it no longer needed to run another phase 3 trial for Pimavanserin. This was very good news as the company would have had to wait longer to file for approval, and another trial would have possibly taken another two years to conduct.
The FDA had stated that the positive pivotal phase 3 study 0-20, plus the other safety studies would be adequate enough for approval. While that remains as good news, the downside is that ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) is not planning to file its NDA for Pimavanserin until late 2014. The good part about Pimavanserin is that it can also be used to target against Alzheimers disease psychosis.
The company currently boasts a market cap of $948.2 million, and trades way above its 52-week low of $1.30. Just in 2013 alone, ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) is trading up 165% year to date. That doesn’t mean investors shouldn’t consider investing in the company. Long-term there is more opportunity in this name as the company still has a huge pipeline of other drug candidates.
Results that started it all
The phase 3 trial was to test safety and efficacy endpoints of patients with Parkinsons. In terms of safety, there were only a few patients who experienced moderate to mild adverse events. In the worse case scenario, 11.7% of patients ended up with Urinary Tract Infection as a side effect of Pimavanserin. The key lesson here is that patients needed this drug, and the study was safe. The patients didn’t mind the side effects, so much that 90% of them wanted to roll over to the next planned phase 3 study.
The efficacy seen was amazing, and that’s why ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) had gone up so much over the past few months. The efficacy scale used to measure Parkinson’s disease is called SAPS-PD, a 9 item scale. The Pimavanserin arm achieved a 5.79 point improvement at day 43, compared to placebo only achieving a 2.73 point difference. These results showed that ACADIA achieved its primary endpoint by achieving a significant number over the placebo.
A drug like this, with significant outcome, would be a huge boost to Parkinson’s disease patients. Why an investor should take a look at this company is because the market is huge for this indication. The market for Parkinson’s is expected to grow according to the National Parkinson’s Foundation.
There is a huge opportunity with this name as there are about one million patients in the United states with Parkinson’s disease. Worldwide, it is an even bigger number with about six million people with Parkinson’s. I think with this in mind, ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) is a good investment for any long-term buyer.
