On August 31, 2015 Rxi announced that the 30-day review period for its IND of RXI-109 for scarring of macular degeneration has passed its review period and the IND is now active. The whole point of the 30-day review period is for the FDA to look at pre-clinical data and conclude whether or not the company’s drug is safe enough to inject into a patient’s eyes. Considering 100 or more patients have already been injected with RXIi-109 for skin scarring with no adverse effects it was no surprise that the FDA approved a trial to start for RXI-109 in retinal scarring.
The trial known as RXI-109-1501 will use RXI-109 to attempt to shrink the scarring that occurs in Wet-age related macular degeneration patients. One quick thing to note though is that the company has a lot of confidence in its RXI-109 drug, which is why this compound will be tested in patients with an advanced form of the disease — meaning not newly diagnosed, but those who have had Wet-AMD for years.
There are drugs that treat Wet-AMD but those drugs only deal with the leaking/growth of the blood vessels of the disease. For instance Regeneron Pharmaceuticals (REGN) has its very popular drug Eylea which treats the leaking of the blood vessels in Wet-AMD but does absolutely nothing against the scarring that occurs. Rxi is also in works of its own anti-VEGF Wet-AMD drug so if the RXI-109 deals with the scarring component of the disease then it could quite possibly combine RXI-109 together with its own anti-VEGF drug to make an even more stronger Wet-AMD drug.
Even better news is that because RXI-109 has already been tested with multi-dosing in skin scarring it won’t have to start off with single-dosing in the RXI-109-1501 trial. This means the company can avoid having to start off with a single dose and can go straight to a multi-dose trial which should save the company time and money.
The importance of RXI-109 inhibiting scar growth in Wet-AMD patients is attempting to improve vision for these patients. That is because the aggressive growth of scarring in these patients continues to lead to additional vision loss. If this drug can successfully work it could potentially improve vision in these patients which is also the main goal of an anti-VEGF drug. If the Institutional Review Board — IRB — allows the trial to start it should start recruiting patients sometime in early Q4 2015.
Synergetics USA (NASDAQ:SURG) & Valeant Pharmaceuticals (NYSE:VRX)
On September 2, 2015 Synergetics USA ended the day up 40% after it had announced that Valeant would acquire the company for $166 million. Valeant made an offer to acquire all of Synergetics’ outstanding shares for $6.50 per share which was a 48% premium over the previous close. Synergetics is a pharmaceutical company that is focused on creating surgical products for ophthalmology and Neurosurgery.
Shareholders might be able to receive additional money on top of the buyout money. That is because if pending sales milestones are met Synergetic shareholders would get an additional $1 per share as well. It will be no rush though for the pending milestone payment because it can occur at anytime after the close of this acquisition of Synergetics by Valeant. The closing of the acquisition is expected to occur by Q4 2015.
Valeant is notorious for building its value by acquiring a lot of pharmaceutical companies. One month before this acquisition Valeant bought out Sprout Pharmaceuticals which had its sexual female disfunction drug ADDYI approved by the FDA. Valeant realized the potential market value of the drug and probably decided to quickly scoop up the company for a big sum of $1 billion. Although like this deal and many other deals Valeant has been acquiring companies randomly for their potential profit.
This time around though the acquisition is more of a close synergy with Valeant’s current pipeline. That is because awhile back ago Valeant bought Buasch and Lomb, which primarily dealt with the selling of eye treatment products to the public. As mentioned above Synergetics is a company that strives to make products for ophthalmology which Valeant probably thought would have good synergy with Bausch and Lomb products.
Acadia Pharmaceuticals (NASDAQ:ACAD)
On September 3, 2015 Acadia Pharmaceuticals had announced that it had submitted its New Drug Application — NDA — for NUPLAZID to the FDA. The drug NUPLAZID is a drug created by Acadia to treat Parkinson’s disease patients with psychosis. The drug performed quite well in late stage studies not only proving positive efficacy but also proving to be safer than other anti-psychotic medications.
One question we must know before looking further is to actually know what that the psychosis component means for the Parkinson’s disease? The psychosis component involves patients who experience hallucination and delusions, making everyday life functioning very difficult to maintain. If NUPLAZID is eventually approved by the FDA it would be the first Parkinson’s Disease Psychosis drug to be approved for this patient population.
The National Parkinson’s Foundation estimates that there are 1 million people in the U.S. diagnosed with Parkinson’s and about 5 to 6 milion people worldwide. Although approximately only 40% have the psychosis component of the disease. Despite that, Parkinson’s Disease Psychosis is still quite a huge market for Acadia to target.
Just how powerful was efficacy of NUPLAZID in a late-stage Phase 3 clinical trial? Well so powerful in fact that it was able to meet on all the primary and secondary endpoints of the trial, in addition of showing the ability for the drug to reduce psychosis greatly compared to a placebo compound. This phase 3 trial was known as the Phase III-020 study.
NUPLAZID has also already received FDA priority review by the FDA to advance this drug product as quickly as possible to the market. This is because drugs granted with FDA priority review are given a review time of 6 months instead of 10 months. This pushes up the time table for FDA approval to get this drug to patients who desperately need this improved treatment option.
In additional news the board of directors for Acadia announced the appointment of Steve Davis to Chief Executive Officer — CEO. The ironic thing though is that Steve Davis joined Acadia first as its Chief Financial Officer and now is placed in the role of the company’s CEO. He was made interim CEO previously until a new potential suitor could be found for the position but it seems as if the board were happy to make him a permanent CEO instead.
Disclosure: Author is Long Rxi Pharmaceuticals (RXII)
[Image Courtesy of Wikipedia]