1)The SMA drug study could be stopped at any time based on the safety and efficacy. These children are beating the natural history children both in life time existence and better neurological findings. The approval could be as early as later this year, up to maybe mid 2017.
2)The TTR-amyloidosis drug which is about 12 to18 mos ahead of the competition. Possible approval sometime in mid 2017.
3)The Factor XI inhibitor has been projected from a well-respected person at ISIS to probably get approval in the year 2018.
4)The GCGR blocker should have data out later this year. The amazing thing about the latest data is that if ISIS doses it at lower doses for a prolonged period of time these patients are starting to show the very high efficacy that was seen in the higher but shorter dosed patients. If you remember this drug had some concern about liver enzyme elevations. That does not seem to be the case with the drug is dosed at a lower dose and you do your rechecks a little farther down the road compared to that original study. It was noted that there are seven to eight parties interested in this drug if this prelim data pans out.
5)The GCCR blocker should be coming out with data some time in the second half of the year.
6)The PTP1-B inhibitor looks even more interesting than it did before. Most of the studies were done on African women in South Africa. They were discovered to have some genetic variant where the drug was not very effective. Amazing enough the PTP1-B works the same on African Americans as it does on Caucasions. When you subtract out the South African population the ability to lower HgbA1c was greatly improved to over 1%. This drug also has the advantage of being almost the only insulin sensitizer. According the people at ISIS endocrinologists are really looking forward to this drug getting approved for that very reason.
There is tons more things going on but these are probably the ones that will get attention first. t
First will be the FDA allowing BIIB/ISIS to do what is happening with SRPT's drug for DMD, that being a rolling evaluation of the drug so that it can by used and the drug having on-going data reporting for safety checks and efficacy. I think that this is highly probable from what we are seeing with those children.
Second will be the FDA allowing their Factor XI inhibitor to be studied in patients with atrial fibrillation that also have a heart valve replacement. No Factor Xa inhiibitor nor Factor IIa inhibitor can replace coumadin for this indication. If the Factor XI inhibitor can get that indication and the indication for treating Stage V renal patients with it then this drug will be a multiple billion drug on those two indications alone. t
One thing to really watch out for in regards to ISIS Factor XI inhibitor is the indication for patients with atrial fibrillation WITH a mechanical heart valve. This patient group only has coumadin as a choice now. If you look at just the two indications for this drug, the aforementioned indication and also the one that they have already made public, that being the patients with Stage V chronic kidney disease who also have atrial fib......those two indications will put this drug over $2 billion in sales. The other interesting thing to note is that anyone who is anyone in coagulopathy wanted to make sure that they would be allowed to study the drug even though it got sold to Bayer. Many more good things to note. Just a matter of a little bit more time and shareholders will be very amply rewarded IMO. t
Crusoeandrobin, Did occur to you that this one little payment of $10 million is worth more than vicl has made in over 5 years for milestone payments. Now with the pxx-pxx sandwich swallowed and your $4 million dollar once in a fortnight being digested by wall street vicl really took it on the chin today. I sure hope you Chums sell vicl and get out while you still have some money before it hits the pink sheets. The clock is running as long as it stays below a buck. Please send pictures of potential commune locales and let us vote on which one is best for the Chums. t
If I have a chance will give summary later tonight on it. t
Shelly, you are really not an ISIS investor and really a secret short or you are a terminal neurotic. If you are the second profile I'd sell out and but something very safe and leave the board because if the stock is up you are worried, if the stock is down you are worried. You won't be able to win and you won't be able to sleep. You will ruin your mental health. If you are the former you are then a miniature Chum and you will be spanked in the in intermediate and long term very badly. Either way ISIS isn't for you......ever hear of IBM? t
ISIS has about 400 employees and they have 38 drugs in the pipeline. They may have 40 by year's end. PFE has 88 drugs in their pipeline with 78,000 employees. Dr. Crooke was quoted recently that they have learned and developed more in the last three years than they have over two decades. That is usually how research into new areas goes. Look for ISIS to become the world leader in the orphan drug space within the next two to three years. t
Amgen and Merck (MRK) expand their collaboration to evaluate the efficacy and safety of talimogene laherparepvec in combination with KEYTRUDA (157.35)
The co and Merck (MRK) announced an expanded collaboration to evaluate the efficacy and safety of talimogene laherparepvec, Amgen's investigational oncolytic immunotherapy, in combination with KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, in a Phase 1, open-label trial of patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
In addition, the companies announced that a global, randomized Phase 3 trial evaluating the combination in patients with regionally or distantly metastatic melanoma is being initiated. As previously announced, the compounds are being studied in a Phase 1, open-label trial in this patient population.
This trend will help RNN IMO. t
But that is all good because as a stand alone company it will reach REGN status sometime soon. In the mean time ISIS just got a price tag increase:
$ISIS BMO target $95 today with antitrust clearing news.
The stock is up on over three times normal volume. More importantly this patent as someone else noted was given in a country where it is hard to get patents. The potential is there for RNN to be sort of a partner in any old CA drugs where a big pharma can take a generic come to RNN and get a proprietary drug out of it. The delivery system could make for that win-win-win situation where the patient gets less toxicity with less drug delivered and delivered to the right target, the purchaser of the technology will have a proprietary drug and hopefully market leader, and RNN should be able to collect royalties from the drug......which I would estimate to be in the 12-15% range for each drug. That is about what the inventors of the XL delivery system got for small molecules that used their technology like the old Procardia XL. The royalities could be somewhat higher if the drugs being used aren't small molecules or based on the delivery system being more complex. This somewhat good news doesn't really pertain to the main core of RNN's business but it shows that the company is not sitting on their hands. Continue to look for RNN to be above $3 per share over the next eight to twelve mos. now.
Flintstone, I want to thank you for the early prune head cheer as it looks like it might help ISIS. I heard that Dr. Dorr got counseling and learned that you can't go backwards, only forward and that he is doing well and regrets that his name keeps coming up on this board without his permission. Oh BTW I hope you sell some vicl before it goes bankrupt so you can get some new shoes.......I've always marveled at how you stop your car with your feet. t
They have lost almost all of their net worth banking on vicl, they have eaten a pxx-pxx sandwich in the last few weeks, they remain very loyal to their meager pipeline and their sea captain vj. They should all have been extras in the movie Helen of Troy with that blind loyalty. t
Again you Chums are losing credibility on the board in everything you say except for the reverse VOO-DOO curse and the fact that we know you all like pxx-pxx sandwiches. Where is your link to such info??? BTW did you Chums get together over the weekend for a Chum commiseration and decide to sell vicl from what you've learned here?? t
Kynamro has three presentations coming from the ISA in Amsterdam later this month. ApoB100 inhibition has a good chance of being found to be much more effective in lowering CV events in patients with Stage V CKD and on dialysis. Statins barely help in this group of patients, so far PCSK9 inhibitors the same. Could relate to elevated levels of Lp-PLA2 levels that this population has in higher amounts than the general population, and this population also has HDL that doesn't work. Also, watch for possibly Mipo's ability to stop progression of Alzh dx. hueynotesnothing, you might want to buy some ISIS and hide it from the Chums. Even in a commune you deserve some privacy. t
tudywad, You are right, I'm not afraid to work. I also like to help people and have been trying to help you Chums now for over three months. Whoever is the lead Chum is steering you down the wrong road. Be a good alien and quietly sell your vicl and buy ISIS. You won't regret it and everyone here will sleep better knowing that the aliens won't be homeless without a planet. t
I don't think you have a science background and I don't think you really understand the product or its potential. You seem to give out a good insult yourself as well. t
Chums, I'm going to listen to this Friday's CC and report findings here because you guys don't reside in the usual area one would expect...that being the vicl board. I'll give you an honest opinion of whether I think you are betting on plug or a real thorough bred when you continue to hold what seems to be an extremely bad dog/plug horse. I can't recommend enough that you sell half of your vicl now and let's see what the CC shows to be the future. I just wish that vj would help bankroll your commune so that you would have some place to go should vicl go down the tubes as most experts I check with expect to happen. That includes technicians, biotech analysts, feng-shui experts, and other people in biotech. The sooner you leave this dinosaur the better, but let's give it a last chance. t
Listened to it live, and will re-listen tonight. I think it was an excellent CC and to me it reinforces that the time line for ISIS always being in the dog house with the general public and the whippling boy for the shorts will soon end forever.
Xarelto is partnered from Bayer with Janseen and they are owned by JNJ. Thus the reps from Janseen do 90% of the selling of Xarelto at this time. So something to keep your eye on as this develops over the next few years with Xarelto's patent waning. Bayer's choice will be to really ramp up their own sales force(assuming approval of Factor XI inhibitor of course), or the transfer of sales power over to the Janseen sales force that is selling Xarelto now. Janseen did buy that Mab not yet in trials as a Factor XI inhibitor potential competitor about a month ago.
The thing that Bayer has going for it is the "blue prints" in regards to setting up studies for this area of medicine in what you need to know. They are coupling that with extraordinary interest in this field to the point that they aren't going to let any moss grow under their feet. Money has never really controlled Dr. Crooke and that's why the upfront payment doesn't mean too much to him. The rapid, broad advancement of this potentially huge block buster is what drives him. This drug should be drug of the year in about two to three years. t
littlekim, ISIS has two drugs on the market right now. Both have more potential than the drugs that vicl has. That isn't the issue, and what will make you sing a Rainy Night in Georgia will be the upcoming meds from them that will be blockbusters. No one can say they we weren't warned by the Chums, so Don't Get All Shook UP, and don't have things Always on My(your) Mind. You and the Chums need to be saying to each other Baby Let's Play House for when you get into the commune. It will be a Dark Moon over you Chums soon. You will be in Double Trouble over a Full Moon. You will call Johnny and Franky about your G. I. Blues from holding vicl and not listening about buying ISIS. You will keep on thinking about Getting Home Somehow, but with your low vicl share price you won't make it out of the commune. You will Have Hard Luck and Hard Knocks because you were a hard head. You will say Help Me because I'm Hot Dog. You will also say I Don't Want to Be Stung just because I was stupid and invested in vicl. I'm Indescribably Blue because I've been a vicl holder. It Hurts Me, I sure wish I would have listened to the ISIS holders.
That is OK LilKim, you've been channeling Elvis:
http://en.wikipedia.org/wiki/List_of_songs_recorded_by_Elvis_Presley Sell vicl and you'll be OK. t