I know several Big Pharma companies are looking to increase their Rev stream are now looking closer at ACAD. It is within reach of several huge companies. ACAD has the World Wide Rights to a Billion Dollar Drug, it will be the only drug indicated for a terrible condition, PDP. This offers an incredible revenue stream for a potential suitor(s). A company with established distribution channels will turn Nuplazid into a money making machine immediately after the approval. At this point, it seems like the cake is on the table we just have to light the candles. Let us say Nuplazid hits the 1+ Billion Rev within 2-3 yrs if it goes it alone. If you look at a few companies BMRN, ILMN, INCY, VRTX, ALXN, They have an Avg Rev stream of $1.5 Billion, an Avg MK of 20.73 Billion, and an Avg share price of $109/share. I think ACAD share price in 2-3 yr will be well over $100/share. A Buy Out will have to approach that number. Several suitors could be, JNJ(38B cash), PFE (20B cash), MRK (13B cash), SNY(10B cash)- Nuplazid will be the first of it's class into a major CNS market. Nuplazid is also a foot in the door for Alzheimer's Disease (Alzheimer's Agitation) not to mention the cherry on top-Off Label use for the many psychosis conditions thanks to the Amarin Corporation which settled its case with the FDA....which now allows "truthful and non-misleading speech" promoting off-label use -meaning not approved by the FDA. So lets get the lighter out and get ready to blow out the candles.
Please don't give that A-ole any credit, he's an opportunist. Many of us longs have been saying that for a few years already. AF jumps on when it is obvious approval is eminent and a Buy Out is on everyone's mind. He's like a broken clock...correct twice a day. His calls are no better than a coin flip. 50% correct. His best days are behind him. Believe me at the first sign of weakness he will jump off the ship and say " I told you so. ". He's an ingrate carpetbagger.
This is from my previous post ....A drug price comparison site goodrx-dot-you know what, showed the Abilify 20 mg BRAND NAME price, 30 tablets, per month for 12 months TOTAL 1 yr range is $15,216 to $17,316. So I think the price quoted (13K) will be a Brand Name price for 1 yr, but for the lowest dose tablet. ...Abilify comes in 2mg, 5mg, 10mg, 15mg, 20mg and 30mg. It comes in Oral solution, disintegrating tab, tablet and vial(injection)....See recent post reg B of A
So if we use the 13K per yr/ per patient- 400K PDP patients in the USA with 1M PD patients only, So after 1 yr of release after approval, lets say a very conservative 10% of the PDP patients are taking Nuplazid. That's 40,000 patients x $13,000 per yr = $520,000,000 by end of year 1, if its closer to 20%(80K patients) that would be $1,040,000,000. And remember the 13K per year is for the lowest dose pill only. Share price...I am thinking at this point if the market stays weak, approval is worth about $ 35-45+/share and after the 1 year of sales approx $70-80+. BUY OUT just after approval, about the same as that 1 yr price. In a hot market we are talking at least 30% higher. This is what I consider a conservative view. Why, only considering the low dose pill price for only 10% of the patient population, not considering approval in the EU with their 1.6M PD and 640K PDP patients, not considering OFF Label use, bidding war etc
ACAD could be " The Stock of the Year 2016 ".
3 Upcoming FDA Decisions We're Most Excited About
Here's how Acadia, Intercept, and Clovis Oncology could win big in 2016.
Photo source: flickr.com.
Interested in what biotechs might soon bag an important new drug approval? Then the Motley Fool has a treat for you today.
Below, three of our contributors share their picks for biotechs on the cusp of a make-or-break FDA decision. The upside of a green light is huge considering how much the odds are stacked against an investigational compound making it all the way to approval.
It takes about 12 years for an experimental drug to travel from the laboratory to your medicine cabinet, and the chances it will make it are a meager one in 5,000. According to Forbes, the overall cost of creating a new drug averages $5 billion. Of course, that takes into account all the failures; companies don't spend that on each drug.
The good news is that about 80% of drugs that made it through the gauntlet of clinical testing to Phase III gain FDA approval. So, when a drug gets close to receiving a regulatory decision, investors should be on high alert.
Brian Feroldi: One upcoming FDA decision that I'm especially excited to hear about is for ACADIA Pharmaceuticals' (NASDAQ:ACAD) Nuplazid, which was submitted last last year as a potential treatment for psychosis associated with Parkinson's disease, or PDP.
The National Parkinson Foundation estimates that roughly 400,000 Americans suffer from PDP, which can cause hallucinations and delusions and places a huge burden on caregivers. In phase 3 trials, Nuplazid was shown to lower the impact that PDP had on patients' lives when compared to placebo, and it also helped improved patients' sleep cycles. Nuplazid helped to reduce the burden placed on caregivers, and the results were seen regardless of the patient's age, sex, or race.
With no other approved drugs on the market to treat PDP, the FDA granted Nuplazid with breakthrough therapy designation and has given it a priority review. The target PDUFA decision date is May 1, 2016 .
This date should be exciting for investors, as well, as peak sales for Nuplazid are currently running around $2 billion. That number could grow considerably in the future, too, since Nuplazid is also being studied as a treatment for Alzheimer's Disease Psychosis and Schizophrenia. If Nuplazid gets the green light on May 1st, then it bodes well for the drug's chances with future conditions. I, for one, am excited to see what will happen.
Whatever, its the safest drug and the ONLY drug for the indication of PDP. It won't matter, the FDA will not be able to prevent doctors from using the drug off label once it gets rolling. It's coming down the tracks.... and there's not a dame thing the shorts can do about it.
Sorry about your father. It is a terrible condition.
It is very frustrating for the doctors and nursing staff also due to the lack of good, safe options.I had several patients with various types of dementia. One patient in particular became very combative with his cane towards another patient because he thought the patient was going to kill him. I gave him Seroquel...but it didn't seem to help until the dose was increased and made him sleepy in the day time. He slept most of the day. The nurses tolerated this sedated patient which was easier to deal with than a combative patient. Now we have Nuplazid, it will be a God Send for those patients and their families.
So how come he didn't bad mouth the Mexican government, one of the most corrupt governments in the world. Everything in Mexico is a big pay off, from the guy that gives you a parking ticket to the President of that rat hole. The government doesn't give a #$%$ about the people, wouldn't even provide clean water or a decent sewer system...The government is packing away all their cartel pay off money and oil money into off shore accounts. They turn their back to all the murders and drug dealers. Mexico, the land of my people and I am so glad my grand parents walked across the muddy Rio Grande in the early 1900's. Missing students...what missing students? Oh they gave it a show to go out and look for them, what a joke. When police went looking for the 40+ missing students they found a mass grave yard...but it wasn't the students, it was 150 other dead people that they don't even know who they are or who killed them.. But the Pope ( I am Catholic too) has the time to whine about Trump wanting a secure board, please. Don't get me started on Mexico, my people.
Anavex Life Sciences Corp., a biopharmaceutical company focused on the development of new therapies for neurodegenerative and central nervous system (CNS) diseases, among others, recently announced the presentation of preclinical data for one of its lead drug candidates, ANAVEX2-73, as a multiple sclerosis (MS) treatment. The preclinical study’s lead investigator, Dr. Robert Lisak, will present a poster on the study’s results at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2016.
The poster, “Sigma-1 Receptor Agonists Inhibit Oligodendrocyte Cytotoxicity Induced by Molecules Involved in Cell Damage in Multiple Sclerosis,” will be presented on Friday, Feb. 19, by Dr. Lisak, an MD and professor of neurology at Wayne State University School of Medicine, Michigan.
MS is characterized by harmful pro-inflammatory damage to myelin, the lipidic material that protects the nerve fibers in the central and peripheral nervous systems. Demyelination, the process of myelin destruction, is a hallmark of MS, leading to progressive neurodegeneration and synaptic failure, with no current effective therapies to stop it.
Myelination, the process of myelin formation, is carried out by oligodendrocytes in the CNS. Although these cells do not proliferate or regenerate in the adult CNS, oligodendrocyte progenitor cells (OPCs) have been shown to migrate, proliferate, and partially remyelinate axons injured by MS lesions. As a result, pharmacologic agents that decrease or prevent the death of oligodendrocytes and OPCs, and protect them from damage by inflammatory agents present in MS lesions, are greatly needed.
Researchers have been focusing on the sigma-1 receptor (S-1R), a receptor upregulated during cellular stress and involved in calcium homeostasis, whose activation through agonists has been shown to have neuroprotective effects both in vitro and in vivo.
Dextromethorphan (DM), an approved S-1R agonist, is reported to protect oligodendrocytes in vitro from the harmful effects of a series of toxic agents, such as reactive oxygen species (ROS) and glutamate. In this study, the team investigated if ANAVEX2-73, a S-1R agonist chemically unrelated to DM, also had a protective effect on oligodendrocytes. ANAVEX2-73 is a clinical stage compound currently being assessed in a Phase 2a trial for Alzheimer’s disease treatment.
Researchers prepared cell cultures enriched with oligodendrocytes from newborn rat brains. These cultures were incubated with different concentrations of ANAVEX2-73 and exposed to different toxic molecules. Through analysis of cell death, they observed that, after exposure to any of the toxic molecules, ANAVEX2-73 reduced oligodendrocyte cell death by over 50 percent.
According to the meeting’s abstract, the research team concluded, “Studies to determine the relative roles of S-1R agonism (…) are objectives for future studies. ANAVEX2-73 and DM are small molecules that enter the central nervous system and thus have potential to provide protection of OL [oligodendrocytes] in MS.”
The Maiden and the Cat
My love but lives an ocean away
He sails there far today
I spy a glimpse a dream in his eye
'Twas a cloudy sky
My brother is teaching the cat to dance
How funny that would be
Meow kicks up and jumps so high
It rains upon the sea
But merry old men in books of lore
Gorge beer upon my floor
Till my love comes back to me
A cat is all I see
OK I'll take the 90-95% Approval chance with one side note...the closer we get to May 1, the higher the % of Approval chance. So tomorrow its 95%...Tue 96%...Weds 97%...Thur 98%...Fri 99%....Sat 99.9%. Sun we are going to party like its 1999.
What we will be witnessed to is Transformation. A small risky biotech into a major company with a NEW, ONE OF A KIND, FIRST IN ITS CLASS DRUG that will be the ONLY DRUG INDICATED for a condition, PDP, that rivals most World Wide Epidemics. And ACAD owns the World Wide Rights. The train is about to leave the station.
I have a house for sale in Pueblo, Colorado...I kept getting low ball offers. My agent encouraged me to counter offer them, but that didn't help. So I decided to treat these potential buyers like bashers. The next 2 low ball offers I got I told my agent to IGNORE them. Do not counter - in fact don't even answer them. It worked. The next offer was above the sale price. Thank you bashers.
After 30 yrs of market experience...I learned just when you think you got it covered the market has a way of making you look foolish. Good luck.
The security systems are all down...a short dimwit is trying to still Dino embryos shares...and the ACAD T rex is about to break though the down electric fence.