FDA approves Intra-Cellullar's schizophrenia drug, shares soar 85% By Trisha Roy , Reuters•December 23, 2019 By Trisha Roy (Reuters) - Intra-Cellular Therapies Inc said on Monday its lead drug to treat schizophrenia in adults has received approval from the U.S. Food and Drug Administration, sending its shares soaring 85%. The company said it will price the drug, Caplyta, closer to its launch. Caplyta, which has been approved as a once-daily dose of 42 mg, has shown to regulate three neurotransmitter systems — serotonin, dopamine and glutamate — linked to severe mental illnesses. Intra-Cellular plans to launch the drug later in the first quarter of 2020 and is in talks with health insurers on the its potential coverage. The company will market Caplyta on its own worldwide, it said. The approval comes with FDA's harshest warning that the drug is not for the treatment of patients with dementia-related psychosis. Schizophrenia is a chronic mental disorder that causes distortion in thoughts, hallucinations and feelings of fright and paranoia, affecting about 2.4 million adults in the United States. An approval will de-risk the market inefficiency driven by investors' concerns regarding the pace at which Caplyta will be adopted post launch as a differentiated neuropsychiatric product in early 2020, Cantor Fitzgerald analyst Charles Duncan said, ahead of the FDA decision. "We anticipate first couple of quarters to be driven by pharmacy stockpiling with sales revenue reflecting in the third quarter of 2020," added Fitzgerald. Existing anti-psychotic drugs in the market include Rexulti from Danish drugmaker H. Lundbeck A/S and Japan’s Otsuka Pharmaceutical Co Ltd, Allergan Plc’s Vraylar and Johnson & Johnson's Invega. In trials, Caplyta did NOT CAUSE AKATHISIA, a feeling of jitteriness among patients, which is extraordinarily uncomfortable and makes people "jump out of their skin", the company said. The drug is also being developed by Intra-Cellular for other indications including bipolar depression, depressive disorders and agitation in patients with Alzheimer’s disease. Shares of the company were trading at $23 before the bell and were set to open at more than one and a half year high.
Well, it’s not good for the rest of the branded drugs. But remember one thing that we have that they don’t have, and that’s a brand new batch of patient profiles to start 2020 with, thanks to good old Max! Yes, we will lose some people to Intra-Cellular, but no big deal. Lundbeck can always find some poor laid-off bastard/bitch to hire. Stay focused! Stay frosty! The enemy will be everywhere in 2020! Hone your skills to a razor’s edge {whatever that means}. Rexulti will be King of the Atypicals in 2020!
Keep on dreaming. Otsuka will boast record sales at the end of 2020, not because of more scripts, but because of 2 totally unjustified price hikes!!! The company will not even bother to tell us, our customers will tell us that their patients are outraged!!!
That’s exactly why the government should impose price controls on drugs, especially me-too drugs like Rexulti. If a drug cannot prove superiority over what would be their competitors (not every single one) in head-to-head studies, the FDA should reject it. Tell us, what are YOU going to do differently with AM, Rexulti or Trintellix in 2020 to hit your sky high goals? This should be fun!
What can you do differently???? We have not received ONE new, creative piece of material for years!!! Instead we rehash the same bullshit on every call. It's no wonder physicians shut their doors. There is nothing new or valuable about Rexulti for the providers to spend their time with us. If I was a provider I would definitely NOT see a Rexulti rep!!! Total waste of time at this point. I just wonder what all these overpaid morons at the home office do all day??!!
Probably the same as you. You pretend to work, get an undeserved pay check and gripe about it every step of the way. I think it’s you who is the fraud. Quit and do something honorable or worthwhile in your mind.
Since you are so smart....Remember WIIFM? (what’s in it for me) So tell me, what’s in it for the Provider at this point???? Waiting for your answer, dipshit!!
Seems I struck a nerve or hit too close to home. If you don’t have a job that provides any value or substance, then quit. Don’t resort to profanity or act offended, just go away. Flip houses, flip burgers, or flip those ‘sale’ signs near street corners but you aren’t making a difference here. Look in the mirror. I have a huge support of writers because I will it that way. My enthusiasm and passion causes people to act and write. Been that way with every products I’ve sold. I know people like you: C student, lucked into this job and thinks they are smarter and more deserving than everyone else. Go start a tech company or a restaurant. Otherwise you are just a leach on the system.
As I predicted...you can't answer the question of what's in it for the provider at this point!! Thank you Mr DM. And I hate to disappoint you: I was never a C student. Anyone making such an assumption without having seen my academic record has not exactly eaten the intelligence with a soup spoon....Not that it matters, but I also have an MBA and finished in the top 10% of my class. Now, go ahead and keep drinking the company kool-aid!! And no, I have absolutely no feelings of entitlement!!! I just want a damn answer to my question, nothing else. I don't believe for a moment that your ear-to-ear grin and enthusiasm sells anything after you have seen the doctor for over a hundred times with the same information. But nice try!!!
"Leach on the system"....who isn't a leach on the system?????...We all are, you and myself included!! When you promote cough syrup and quinidine for over 1200 bucks a month, when the cost should be 10 bucks we are all leaches. So don't give me your phony sophistication and attitude!!
