Acadia Pharmaceuticals (NASDAQ:ACAD)
On November 3, 2015 Acadia had announced that the FDA had given its Parkinson’s Drug, NUPLAZID, FDA priority review. To understand what this means, we must first understand what the FDA priority review actually means? A company is only given FDA priority review if the drug it has developed treats an unmet medical need where patients have no other options. In Acadia’s case the company uses NUPLAZID to help patients with Parkinson’s Disease Psychosis.
Parkinson’s Disease Psychosis patients don’t have any other option to help them with their disease. In this case the FDA wants to review the drug at a quicker pace than normal. Acadia has already filed its NDA for FDA approval of NUPLAZID. Since Acadia got the FDA priority review for its drug it will be reviewed in 6 months instead of 10 months. This quicker review time accomplishes two things. For one it allows the company to generate revenue earlier than it normally would. Secondly it allows these patients with no treatment options to get a drug that will help with their symptoms.
With NUPLAZID possibly being the only FDA approved drug in the market to help these patients it means that Acadia will have no competition. With no competition it leaves the ability for the company to generate all the profit for this indication. In the United states there a total of one million people with Parkinson’s, while the rest of the globe represents around four million people. Of all these people with Alzheimer’s around 40% have Parkinson’s Disease Psychosis. What specifically classifies a patient with Parkinson’s Disease Psychosis is having a few symptoms such as: Delusions, hallucinations, caregiver burden, reduced quality of life.
Rxi Pharmaceuticals (NASDAQ:RXII)
On November 5, 2015 Rxi Pharmaceuticals announced that it had initiated its phase 1/2 trial for retinal scarring of macular degeneration. More specifically the company is recruiting patients with wet-age related macular degenartion — Wet-AMD. When patients have Wet-AMD they have popped blood vessels in the macula of the eye that leak. This leaking of the blood vessels leads to vision loss over time.
There are many anti-VEGF drugs that treat Wet-AMD, but a popular one known as Eylea comes from a biotechnology company known as Regeneron Pharmaceuticals (NASDAQ:REGN). These anti-VEGF drugs definitely help stop the the blood vessels from continuously leaking. Unfortunately, patients with Wet-AMD also get small scars in the eye which can also cause vision loss over time. Eylea and other anti-VEGF treatments do nothing against the scarring that occurs in Wet-AMD.
On the other hand Rxi believes that its RXI-109 drug can help reduce these scars in the eye and help improve vision for these patients. The phase 1/2 trial that is known as RXI-109-1501 will evaluate both the safety and early efficacy of RXI-109. There truly is no clear way of knowing if RXI-109 will be successful in treating these small scars in Wet-AMD patients, but considering the company has already reported positive phase 2a hypertrophic scar results it should also obtain positive efficacy when this trial reports out sometime in 2016.
AstraZeneca (NYSE:AZN) & ZS Pharma (NASDAQ:ZSPH)
On November 6, 2015 AstraZeneca announced that it had acquired ZS Pharma for $2.7 billion. AstraZeneca acquired ZS Pharma in an all cash type transaction for $90 per share. This is pretty big because it was a 40% premium over the closing share price the prior day. Why did AstraZeneca acquire ZS Pharma? The primary purpose is probably because AstraZeneca’s cardiovascular pipeline is starting to trim down a bit.
This is because AstraZeneca will soon be facing a patent loss on a big selling cardiovascular drug known as Crestor. This acquisition of ZS Pharma will definitely help add more products to AstraZeneca’s pipeline. One specific product is a drug in ZS Pharma’s pipeline known as ZS-9 that treats a disease known as hyperkalemia. Before we go any further we have to understand what hyperkalemia is? Hyperkalemia is a disease characterized by high potassium levels in the blood.
High potassium levels in the blood is nothing to ignore, because it leads to irregular heart rhythms. These irregular hear rhythms could possibly lead to a stroke or other heart related problems. The FDA is currently reviewing the ZS-9 drug and if it is approved it could help a lot of patients. The FDA date on whether to approve ZS-9 or not is set for May 26th of 2016. If ZS-9 is ultimately approved by the FDA it won’t start generating revenue for AstraZeneca until late 2016. This ZS-9 drug is a pretty big opportunity though because analysts are expecting it could generate up to $1 billion in sales annually.
Disclosure: Long Rxi Pharmaceuticals (RXII)
[Image Courtesy of Wikipedia]