I could see Vertex CF partnership or acquisition in the near future. I think investors would like this move, as long as it doesn't make Kalydeco, 809, 661, etc...look bad. Any partnership must be perceived as a compliment to their CF program. That Vertex is attacking CF from multiple fronts...really marking their territory in CF. Thoughts?
I wondered what will happen to the stock price if/when another company announces a drug that's as good if not better than what Vertex is doing, though a few years out in terms of approval. I bet it would cause at least some sort of short term storm, maybe not long term. I just want them to keep making great CF meds!
Thanks for the replies.
I actually do not think the trial has begun quite yet, 'Q'...but, maybe I am wrong.
Small clarification, many CF patients take antibiotics on a daily or every other day basis as a prophylactic...usually Azithromycin while others take regular high doses Ibuprofen - both have proven to help FEV1 scores. And, I know Vertex has no intention of pulling people off the trial who take antibiotics.
I am happy to say that my child is scheduled to be in this trial. Originally, we were looking at mid April...then it got shifted to mid May...now it looks like early June. Exciting times, indeed!
I believe that VRTX knows 809 will 'work'...they just want to maximize their success and eliminate ANY mistakes. I think last year's announcement fiasco has made them more cautious.
Wondering if anyone is following the shifting dates for the K+809 trial. Has anyone the latest on when the trial will begin?
MD - While it would be wonderful/incredible/amazing to see 809 shipping in 2014, I would say that is too aggressive and unrealistic. VRTX is already a bit behind where they wanted to be for phase III's right now. I would be satisfied with mid-2015 (without mistakes/reporting errors along the way)... Verty & Third - am I right on this? (not to split hairs, just working to set proper expectations).
Good stuff Verti - thanks!
I would love more/better news on heter's for 809 and/661.
I would say that if the July (or late June - the earlier the better, I say) 'final data' backs the 8.5% improvement recently reported, that the stock could sustain a significant uptick. During this report it would also be good to learn of their plans to implement their phase iii's (and beyond) in a fastidious and responsible manner.
I've ignored so many posters over the last week I wasn't sure if I missed any of Third's postings on the events of the last week.
What say you, Third?
Read that part over, and over...an 8.5% improvement is amazing. The CF audience will take that type of improvement all day long...(especially when it's not an increase due to an antibiotic or steroid!)
Keep in mind what this drug does long term...809/ + K keeps changes the lung surface/environment which not only improves the lung function short term (56 days) but especially long term because the lungs become less hospitable to infections!
Investor don't understand CF and are entitled to freak out if they want to...buy, sell, short, puts, calls, stops...WHATEVER...however, patients can stay positive because this news still very very positive. On to phase iii's!
Kalydeco get's approved in record time & benefiting more than expected.
809 (heading to phase 3...as fast as possible ~ 'all goes well', 2015)
661 (may be so good that it could go to phase 3? ~ 'all goes well', 2017)
Quite the conundrum for Vertex and the CFF!!? :-)
Somebody, pinch me!
These 'first drugs', Kalydeco, 809, 661 are just that...first drugs that attempt to 'correct the root cause of CF". NOTE: they WILL NOT be the end all ~ be all. These wonderful and ‘pioneering’ drugs will be ADDED to the CF patients therapeutic arsenal which, if all goes well, will get smaller as certain drugs become unnecessary since the lungs should become less hospitable to the plethora of issues that plague CF lungs. Use of antibiotics, antifungals, steroids, mucus thinners, the list goes on, should decrease and perhaps someday even stop. Bottom line, Kalydeco (K) or 809+K or 661 should make the lungs a happier & healthy place…that’s a good thing! That’s progress but keep in mind the following…
(God willing) each of Vertex's CF drugs WILL get superseded by a BETTER corrector/potentiator or ‘other method’ of ‘CF correction’ or who knows what down the road (maybe even gene therapy). I bet by 2027 (that’s the patent life, I think) CF patients won't be using ANY of these Vertex drugs because a company like Pfizer, Genzyme, or even a small biotech will have gotten something better approved. In many ways, Vertex is doing the ‘heavy lifting’ for these other companies – several companies are HOT on their path and want this blockbuster market too…that’s not so good for investors…but darn good for CF-ers! Perhaps I’ll find some of you on these other threads along the way?
Here’s a few random thoughts on CF meds/treatments and their respective futures…(to name a few obviously)
- Pulmozyme sales (Roche/Genentech) will plummet 3-5 years after a drug like 809 gets approved – they only way they will maintain revenues with Pulmozyme will be by reformulating to a dry inhaled version, maybe adding something else to make it even better.
- HTS treatments will continue for the long haul – but –the delivery may change to a dry inhaled type…much faster and better than nebulization…there’s a company I think in Boston working on this I think.
-TOBI/inhaled antibiotics – sales will plummet in the next 5-7 years…won’t be needed nearly as much.
-Allergy/Mold sufferers will likely have to remain vigilant even after a corrector/potentiator gets approved…the world needs better drugs to deal with aspergillus it’s a bigger problem than people know.
- Pancreatic enzyme makers are pretty safe. CF patients shouldn’t have as many issues keeping their weight on because they’re not fighting lung infections. But, “gut issues” will persist for years though CF patients should get some relief from these correctors/potentiators. It would be great to see Eli Lilly to get their synthetic pancreatic enzyme resubmitted to the FDA…it blows away Creon and others and doesn’t come from pigs! (no plastic in the capsules either!)
SC vs FEV
I am thinking VRTX MGT was hedging the trial outcome in the case that FEV wasn't impressive they could fall back on SC levels. Now that they have the gold standard looking positive (FEV) they're going to downplay the significance of SC or at least wait until they have results that can be presented in a positive light.
Thanks for the notes...all in all very very good! Progress! We will certainly try to get her in this trial...but it will all depend on how they set it up. If they're looking for pretty girls with cf...she's a shoe-in. ;-)
question....assuming things continue to go well...when could 809 be available?
I don't understand the wording "pivotal trial" vs phase 3 trial - are they the same? Then...
After a successful phase 3 I understand there's still the NDA (new drug approval) process...I think that took 4 months, for Kalydeco, right but that was unusually fast, right?
Thanks for the input!!!
Personally...I felt SC value is important but takes a back seat to FEV increase.
This is the news that DD 508-ers have been seeking. Now to get to phase iii and FDA approval...I've become too cynical to think that's a slam dunk, but I am happier than years today - the future is brighter today than ever before.
Another piece that I picked up from the transcript of the earnings report was the following...especially the last sentence. knocking on wood.
"In addition to the 3 pivotal studies of KALYDECO monotherapy that I just mentioned, we're also conducting 2 Phase II exploratory studies that combine KALYDECO with a CFTR corrector, either VX-809 or VX-661 and people with CF with a common CFTR mutation called Delta 508. The goal of combining KALYDECO with the correctors is to provide a majority of the CF population with a new treatment option. We expect to get the final results from the study of KALYDECO in VX-809 in mid-2012, followed by data from the KALYDECO on VX-661 study in the second half of this year.
Because we have a deep knowledge and understanding of this disease, we have high hopes for what we may be able to do for the many children and adults living with cystic fibrosis."
"With positive blog data and other positive hints, in my humble opinion, buy on the dips here. Because by the end of the year, this stock should triple."
From your lips to God's ears John50... :-) I am encouraged by some of the verbiage in this release...in particular this quote;
"Additionally, Vertex today announced that it expects to obtain data from multiple ongoing clinical trials beginning in the second quarter, including data from a Phase 2 study evaluating KALYDECO in combination with VX-809 in people with the most common type of cystic fibrosis (CF) and the first viral kinetic data of the nucleotide hepatitis C virus (HCV) polymerase inhibitors ALS-2220 and ALS-2158."
They didn't "have to" remind investors of this fact but they did. Makes me think they're not afraid to highlight 809's potential.